Hepatitis B or C serologies consistent with past or current infections

Known active infections

No active infections requiring systemic antibiotic treatment (oral antibiotics are acceptable at the discretion of the treating physician)

Subjects with uncontrolled serious infections or a life-threatening illness (unrelated to tumor)

Patients with clinically significant active infections

Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled

Use of antibiotics to treat chronic infections within 28 days prior to first dose

Active systemic infections requiring antibiotics

Active clinically serious infections or other serious uncontrolled medical conditions

Active, known, clinically serious infections within the 14 days prior to first dose of investigational product

Active bacterial infections.

Uncontrolled infections

No active serious infections or other conditions precluding chemotherapy

Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).

Active infections requiring antibiotics, physician monitoring or recurrent fevers >100.4?F (38.0?C) associated with a clinical diagnosis of active infection

Active or uncontrolled infections

Patients with serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy

Active viral or bacterial infections: this includes any infections that are being actively treated even if the signs and symptoms appear to have resolved. Courses of antibiotics or anti-viral treatment should be completed before the patient is enrolled

Active hepatitis viral infections

Active serious infections not controlled by antibiotics

Patients with active infection requiring antibiotics are not eligible (with the exception of uncomplicated UTI and uncomplicated respiratory tract infections)

Active (acute or chronic) or uncontrolled severe infections

History of ocular events related to keratitis or corneal disorders, or any current ongoing active ocular infections.

Patients who have an active infection requiring systemic therapy are not eligible, except for uncomplicated urinary tract infections

Uncontrolled infection; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable

Must have no ongoing active, uncontrolled infections (afebrile for > 48 hours off antibiotics)

Active or uncontrolled infections

Severe infections within 4 weeks prior to Cycle 1, Day 1

Any evidence of serious active infections; any infections being treated must complete antibiotic therapy at least 7 days before planned first dose.

Have active (acute or chronic) or uncontrolled severe infections

Serious illnesses, e.g., serious infections requiring antibiotics

Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)

Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active or uncompensated major medical illnesses

Concurrent opportunistic infections

Concurrent opportunistic infections

Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses

Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses

Concurrent opportunistic infections

Chronic infections (e.g., hepatitis B or C, tuberculosis)

Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses

Concurrent opportunistic infections

Repeated infections requiring oral or i.v. antibiotics

Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy.

Patient with active, uncontrolled infections (patients must be afebrile for > 48 hours off antibiotics).

Active systemic infections requiring anti-infective treatment, coagulation disorders or any other active major medical illnesses.

Active or fungal infections requiring systemic treatment within 7 days prior to screening

Uncontrolled active systemic infections

Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections or major surgery within 28 days prior to study enrollment

Severe infections within 4 weeks prior to enrollment;

Concurrent opportunistic infections

Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active major medical illnesses of the cardiovascular, respiratory or immune system

Patients who have uncontrolled infection are not eligible; patients must have any active infections under control; fungal disease must have been adequately treated for at least 2 weeks before study entry; subjects with bacteremia must have documented negative blood cultures prior to study entry

Active infections

Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system. Principal investigator (PI) or his/her designee shall make the final determination regarding appropriateness of enrollment.

Active or uncontrolled infections

Patients with active infections. The principal investigator (PI) is the final arbiter of the eligibility;

Patients with other uncontrolled infections: For bacterial infections, patients must be receiving therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.

Active systemic infections requiring anti-infective treatment, coagulation disorders or any other active or uncompensated major medical illnesses

Patients with any active and uncontrolled infections (such as bacterial, fungal, and new or reactivated viral infections)

Acute treatment for an infection (excluding fungal infection of the skin and sexually transmitted infections) or other serious medical illness within 14 days prior to randomization

Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy

Infections such as pneumonia or wound infections that would preclude protocol therapy.

Uncontrolled infections.

Concurrent opportunistic infections

Active systemic infections requiring anti-infective treatment, coagulation disorders or any other active or uncompensated major medical illnesses

Acute or chronic infections requiring systemic therapy, including, among others:

Systemic rheumatic or autoimmune diseases or acute or chronic infections

Patients with active systemic infections requiring intravenous antibiotics within 1 week prior to enrollment

No uncontrolled infections;

Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses

Concurrent opportunistic infections

No uncontrolled infections;

Other active infections aside from hepatitis

Presence of any serious illnesses, serious medical conditions, serious medical history, active bacterial or viral infections including hepatitis B or C, or known to be HIV positive.

FOR ALL PHASES (Ib AND II): Uncontrolled infection; active, clinically serious infections (> CTCAE grade 2)

Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease

No active infections

Patients with active infections; the principal investigator (PI) is the final arbiter of the eligibility

Severe infections ? 4 weeks prior to enrolment in the study as well as active, uncontrolled bacterial, viral or fungal infections requiring systemic treatment.

Active infections within 48 hours of study entry

Active uncontrolled acute infections

Active uncontrolled systemic infections (defined as infections causing fevers and infections requiring intravenous antibiotics when the intravenous antibiotics have been administered for less than 72 hours); active coagulation disorders or other major uncontrolled medical illnesses of the cardiovascular, respiratory, endocrine, renal, gastrointestinal, genitourinary or immune system; history of myocardial infarction; history of ventricular tachycardia or ventricular fibrillation; active cardiac arrhythmias (active atrial fibrillation is not allowed, but resolved atrial fibrillation is allowed); active obstructive or restrictive pulmonary disease; or active autoimmune diseases such as rheumatoid arthritis

Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment

Evidence of active infections =< 7 days prior to initiation of study drug therapy (does not apply to viral infections that are presumed to be associated with the underlying tumor type required for study entry)

Active uncontrolled bacterial, fungal, or viral infections – all prior infections must have resolved following optimal therapy

Serious, ongoing, non-malignant disease or infection, which in the opinion of the investigator and/or the sponsor would compromise other protocol objectives; participants with active opportunistic infections are ineligible

Known active infections

CELL PROCUREMENT: Patients who are on treatment for other active uncontrolled infections (not referenced above) with resolution of signs/symptoms are not excluded; non-influenza, non-respiratory syncytial virus (RSV), isolated upper respiratory infections are not excluded; other active uncontrolled infections will be excluded

LYMPHODEPLETION: Patients who are on treatment for other active uncontrolled infections (not referenced above) with resolution of signs/symptoms are not excluded; non-influenza, non-RSV, isolated upper respiratory infections are not excluded; other active uncontrolled infections will be excluded

Significant acute or chronic infections requiring systemic therapy

Patients with active infections; the principal investigator (PI) is the final arbiter of the eligibility

Active, clinically serious infections or other serious uncontrolled medical conditions

Active clinically serious infections requiring antibiotics, antiviral or antifungal agents; participants must be off these agents for at least 28 days prior to the first dose of the study drug

Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy

Patients with active infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study until resolution of the infection; patients on prophylactic antibiotics, antifungals or antivirals are acceptable

Active uncontrolled infection; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable

Uncontrolled infections

Concurrent opportunistic infections

Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses

Concurrent opportunistic infections

Active or uncontrolled infections

Acute, severe infection (e.g., sepsis and opportunistic infections), or active, chronic or persistent infection that might worsen with immunosuppressive treatment (e.g., herpes zoster).

Active or uncontrolled infections

Patient with known active herpes simplex virus infections (prior uncomplicated oral herpes simplex virus [HSV] lesions are not an exclusion), prior complications from HSV infections such as encephalitis, or who require systemic antiviral therapy at the time of study enrollment should be excluded

Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease

Not have active, uncontrolled infections

Active, uncontrolled infections

No active infections requiring systemic antibiotics

Active uncontrolled systemic infections (defined as infections causing fevers and infections requiring intravenous antibiotics when intravenous antibiotics have been administered for less than 72 hours), active coagulation disorders or other major uncontrolled medical illnesses of the cardiovascular, respiratory, endocrine, renal, gastrointestinal, genitourinary or immune system, history of myocardial infarction, history of ventricular tachycardia or ventricular fibrillation, active cardiac arrhythmias (active atrial fibrillation is not allowed, resolved atrial fibrillation not requiring current treatment is allowed [anticoagulants count as current treatment]), active obstructive or restrictive pulmonary disease, active autoimmune diseases such as rheumatoid arthritis

Patients with active systemic infections requiring intravenous antibiotics, coagulation disorders, or other major medical illness of the cardiovascular, respiratory or immune system, which in the opinion of the PI or treating co-investigator is not acceptable risk for ACT, are excluded

Active clinically serious infections (> CTCAE grade 2)

Concurrent opportunistic infections

Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses

Active HBV or HCV infections requiring therapy.

Known active infections or oral temperature > 38.2 Celsius (C) fewer than 72 hours prior to receiving study treatment or systemic infection requiring chronic maintenance or suppressive therapy

Subjects who have uncontrolled infection are not eligible; patients must have any active infections under control; fungal disease must be stable for at least 2 weeks before study entry

PHASE I: Patients should be free of active infection requiring antibiotic therapy (except for uncomplicated urinary tract infections)

PHASE II: Patients should be free of active infection requiring antibiotic therapy (except for uncomplicated urinary tract infections)

Presence of an infection including ulcerations and fungal infections in the breast to be studied

Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy

Uncontrolled infection at the time of enrollment; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable

Active infections requiring therapy, including HIV, hepatitis

Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system; PI or his designee shall make the final determination regarding appropriateness of enrollment

Any active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, such as abnormal stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease; PI or his designee shall make the final determination regarding appropriateness of enrollment

Active known clinically serious infections

Patients with other uncontrolled infections (except HIV/AIDS); for bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment; for fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment; progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection; persisting fever without other signs or symptoms will not be interpreted as progressing infection

Evidence of active infections

ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Evidence of active infections

Patients with uncontrolled active infections (fever >= 38 degrees Celsius [C], septic shock)

Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections or major surgery within 28 days prior to study enrollment

Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator

Serious concomitant systemic disorders (including active infections or chronic infection requiring suppressive antibiotics) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator

Patients with multiple viral infections including AdV are eligible if their AdV infection is persistent despite standard therapy as defined above. Patients with multiple infections with one or more reactivation and one or more controlled infection are eligible to enroll.

Patients with other uncontrolled/progressing infections defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.

Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. This includes but is not limited to:

Uncontrolled infections

Patients with other uncontrolled infections; for bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment; for fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment; progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection; persisting fever without other signs or symptoms will not be interpreted as progressing infection; patients with ongoing viral infections are excluded

Patients with other uncontrolled infections; for bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to generating CTLs; for fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to generating CTLs; progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection; persisting fever without other signs or symptoms will not be interpreted as progressing infection

Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment

Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses

Concurrent opportunistic infections

Patients with active, uncontrolled infections

Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses

Concurrent opportunistic infections

Patients with multiple CMV, EBV, adenovirus, HHV6 and BK virus infections are eligible given that each infection is persistent despite standard therapy; patients with multiple infections with one or more reactivation and one or more controlled infection are eligible to enroll

Patients with other uncontrolled infections; for bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment; for fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment\r\n* Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection; persisting fever without other signs or symptoms will not be interpreted as progressing infection

Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved

Patients with systemic infections and/or organ dysfunction mandating a reduced intensity conditioning regimen are also excluded

Active systemic infections, coagulation disorders, or other major medical illnesses precluding major surgery

Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses

Concurrent opportunistic infections

Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system; PI or his designee shall make the final determination regarding appropriateness of enrollment (Turnstile I)

Any active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, such as abnormal stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease; PI or his designee shall make the final determination regarding appropriateness of enrollment (Turnstile II)

Have active, acute, or chronic clinically significant infections.

Uncontrolled infections; principal investigator (PI) is the final arbiter of this criterion

Patients with untreated positive blood cultures or progressive infections as assessed by radiographic studies

Active Mycobacteria, Histoplasma Capsulatum, Shigella, Salmonella, Campylobacter and Leishmania infections.

Patients who have uncontrolled systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular or respiratory systems

Active and uncontrolled infections

Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system; PI or his designee shall make the final determination regarding appropriateness of enrollment (Turnstile I)

Any active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, such as abnormal stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease; PI or his designee shall make the final determination regarding appropriateness of enrollment (Turnstile II)

Patients with untreated or uncontrolled infections

No uncontrolled infections as determined by the investigator

Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved

Active systemic infections (requiring anti-infective treatment), coagulation disorders, or any other active or uncompensated major medical illnesses

Patients with active bacterial infections with systemic manifestations (malaise, fever, leucocytosis) are not eligible until completion of appropriate therapy.

Recent or ongoing serious infections within 2 weeks

Patients with uncontrolled infections; for bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment; for fungal infections patients must be receiving definitive systemic antifungal therapy and have no signs of progressing infection for 1 week prior to enrollment; progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection; persisting fever without other signs or symptoms will not be interpreted as progressing infection

Active serious infections not controlled by antibiotics

Evidence of active infections

Patients with serious uncontrolled infections will not be eligible

Patients with serious uncontrolled infections at the time of planned transplant will be excluded

Any active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, such as abnormal stress test and/or abnormal PFT; PI or designee shall make the final determination regarding appropriateness of enrollment (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)

Active serious infections not controlled by antibiotics

Known infections:

Uncontrolled infections not responding to antimicrobial therapy or requiring intensive critical care or vasopressors

Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator, including active autoimmune disease requiring treatment within the past 30 days

Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).

Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.

Has uncontrolled active infection of any kind. (Patients with infections controlled by active antibiotic treatment are eligible).

Patients with active chronic or current infections requiring oral or intravenous antibiotics are NOT eligible for enrollment to the study until resolution of the infection and completion of therapeutic antibiotics

Active and uncontrolled systemic infections.

Histry of significant chronic or recurrent infections requiring treatment

Concurrent serious infections (i.e., requiring an intravenous antibiotic)

Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment or survival

Acute or chronic infections requiring systemic therapy, including, among others:

Active clinically serious infections (? CTCAE v4.03 Grade 2).

Active infections

Concurrent vaginal, vulvar, anal lesions or symptomatic infections

Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses

Patients with active infections or oral temperature > 38.2 Celsius (C) within 72 hours of leukapheresis. The procedure may be deferred.

Infections:\r\n* Known active current or history of recurrent bacterial, viral, fungal, parasitic, mycobacterial or other opportunistic infections (including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds)\r\n* Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to enrollment\r\n* History of tuberculosis or positive PPD without anti-mycobacterial therapy and/or active tuberculosis (TB) requiring treatment within the previous 3 years; subjects treated for tuberculosis with no recurrence in 3 years are permitted\r\n* Human immunodeficiency virus (HIV) positive, hepatitis B surface antigen or core antibody positive, hepatitis C infections (current or past), active Epstein-Barr virus infection\r\n* History of 2 or more episodes of cellulitis within the past 12 months\r\n* History of recurrent herpes simplex infections requiring suppressive antiviral therapy\r\n* History of invasive pulmonary infections, including candidiasis, aspergillosis, coccidioidomycosis and pneumocystis jirovecii\r\n* History of recurring or chronic infection

Subjects who have uncontrolled infection are not eligible; patients must have any active infections under control; fungal disease must be stable for at least 2 weeks before study entry

Uncontrolled infections not responsive to antimicrobial therapy requiring intensive critical care

Acute/chronic infections, open wounds, or any active infection requiring intravenous antibiotic therapy =< 12 weeks prior to registration

Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator; this includes scleroderma

DONOR: Current serious systemic illness including uncontrolled infections

Current uncontrolled infections.

Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable

Patients who have an uncontrolled infection are not eligible; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable

Active clinically serious infections or other serious uncontrolled medical conditions

Active systemic infections (defined as infections causing fevers or requiring anti-microbial treatment), active coagulation disorders or other major uncontrolled medical illnesses of the cardiovascular, respiratory, endocrine, renal, gastrointestinal, genitourinary or immune system, history of myocardial infarction, active cardiac arrhythmias, active obstructive or restrictive pulmonary disease

Active infections or oral temperature > 38.2º Celsius (C) within 48 hours of study entry

Uncontrolled infections

Active bacterial, fungal, or viral infections – all prior infections must have resolved following optimal therapy

Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease

Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease

Concurrent opportunistic infections

Active (acute or chronic) or uncontrolled severe infections.

Serious, active infections requiring treatment with IV antibiotics

Patients with active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illness of the cardiovascular, respiratory or immune system, which in the opinion of the PI or treating co-investigator is not acceptable risk for ACT, are excluded

Patients with active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illness of the cardiovascular, respiratory or immune system, which in the opinion of the PI or treating co-investigator is not acceptable risk for ACT, are excluded

Subjects must have recovered from major infections and/or surgical procedures and, in\n             the opinion of the investigator, not have a significant active concurrent medical\n             illness precluding protocol treatment.

Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator

Active (acute or chronic) or uncontrolled severe infections

Serious, ongoing, non-malignant disease or infection, which in the opinion of the investigator and/or the sponsor would compromise other protocol objectives; participants with active opportunistic infections are ineligible

Patients with serious uncontrolled infections at the time of transplant will be excluded

They have active infections such as hepatitis or fungal infections.

Patients with uncontrolled infections will be excluded. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.

Significant acute or chronic infections

Active or uncontrolled infections

Poor medical risk because of systemic diseases (e.g. active uncontrolled infections) in addition to the qualifying disease under study.

Active, unresolved infections

History of chronic or recurrent infections that require continual use of antiviral, antifungal, or antibacterial agents.

Acute infections requiring parenteral therapy

Severe infections at the time of randomization

required parenteral antimicrobial therapy for active, intercurrent infections

Active uncontrolled infections

Known systemic infections including, but not limited to hepatitis B or C, or HIV

All infections must be resolved and the patient must remain afebrile for seven days without antibiotics prior to being placed on study

Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy

Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy

Active systemic infections requiring intravenous antibiotics

Patients with known systemic infections requiring antibiotics or chronic maintenance/suppressive therapy

Active clinically serious infections (> grade 2)

Patients with systemic infections requiring active therapy within 72 hours of lymphodepletion

Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)

Uncontrolled infection within one week of the first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable

Patients with active systemic infections requiring antibiotics or active hepatitis A, B, or C.

Active (acute or chronic) or uncontrolled severe infections (not responding to antibiotics), including acute pelvic inflammatory disease

Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy

No active infections requiring systemic therapy

No active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy

Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable

Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).

History of, or presently active or chronic viral infections (i.e. zoster or hepatitis)

Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable

Active clinically serious infections > CTCAE Grade 2

Evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis B, C and HIV

Subjects with signs or symptoms of other major diseases including, but not limited to: end organ failure, major chronic illnesses other than cancer, coagulation disorders, hemolytic conditions (eg, sickle cell disease ) or active infections that, in the opinion of the investigator, make it undesirable for the subject to participate in the study.

Severe infections within 4 weeks prior to randomization

Active (acute or chronic) or uncontrolled severe infections requiring intravenous antibiotics

Uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicines or a recent infection requiring systemic treatment that was completed ?14 days before the first dose of study drug.

Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.

Severe infections within 4 weeks prior to Cycle 1, Day 1

Infections such as pneumonia or wound infections that would preclude protocol therapy

Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.

Patients must have recovered from any major infections and/or surgical procedures and, in the opinion of the investigator, not have significant active medical illness precluding protocol treatment or survival

Research participants with any uncontrolled illness including ongoing or active infections; research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) positive based on testing performed within 4 weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections

Active clinically serious infections

Infections or intercurrent illness requiring active therapy

Active (acute or chronic) or uncontrolled severe infections hepatitis

Severe infections within 4 weeks prior to Cycle 1 Day 1

Other active serious illnesses (e.g., serious infections requiring antibiotics).

Patients who have active infections requiring therapy.

Serious concurrent medical illnesses (including uncontrolled major cardiac, pulmonary, Child-Pugh C liver or psychiatric diseases) or active major infections (including human immunodeficiency virus [HIV], hepatitis A-C)

Subjects with clinically serious infections requiring ongoing antibiotic therapy

Recent infections requiring systemic treatment need to have completed therapy > 14 days before the first dose of study drug

Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have significant active concurrent medical illnesses precluding study treatment

Patients with infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study; patients on prophylactic antibiotics or antivirals are acceptable.

Subjects who have uncontrolled infection are not eligible; patients must have any active infections under control; fungal disease must be stable for at least 2 weeks before study entry

Any evidence of serious active infections

Concurrent serious uncontrolled infections requiring treatment or known infection with HIV

Severe infections necessitating use of antibiotics / antivirals during the screening period

Serious concomitant systemic disorders (including active infections) or psychiatric illness/social situations that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator

Uncontrolled infections

Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled

Patients must not have any active infections

Serious, active infections must be controlled; patients may be enrolled while still on antibiotics as long as clinical signs of active infection are absent

Serious, active infections requiring treatment with intravenous (IV) antibiotics

Concurrent opportunistic infections

Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease

Patients with severe systemic infections

Uncontrolled systemic disease like active infections

Active serious infections not controlled by antibiotics

Active hepatitis or other active infections

Patients with active clinical infections

Active infections not responding to therapy; all efforts should be made to clear the infection prior to enrollment

Known active infections

Active systemic infections, coagulation disorders or other major medical illnesses

Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.

Significant acute or chronic infections, including:

Patients with active infections requiring systemic treatment.

c. Active or failed to control serious infections (CTCAE version 4.03 > grade 2 infections)

Known active infections

Active systemic infections requiring intravenous antibiotics

Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease

Concurrent opportunistic infections

Active infections requiring systemic antibiotics.

Active infections requiring systemic antibiotics.

certain heart problems, active or chronic infections, serious significant diseases, AIHA requiring treatment, other current cancer or within last 5 years

Patients with acute infections (viral, bacterial or fungal infections requiring therapy)

Active clinically serious infections (i.e. patients currently taking antibiotics)( Grade 2 NCI-CTC Version 3.0)

Known HIV and/or Hepatitis B or C infections

DONOR: Current serious systemic illness including uncontrolled infections

Patients must be free of active infections requiring antibiotics, with the exception of uncomplicated urinary tract infections (UTIs)

Current infections requiring antibiotic therapy.

Any evidence of serious active infections.

DONOR: No active or chronic infections

Clinically significant uncontrolled illness or active infections

Active uncontrolled serious infection or sepsis at study enrollment; patients receiving antibiotics for infections that are under control may be included in the study

Uncontrolled infections not responsive to antimicrobial therapy requiring intensive critical care

Chronic or current infectious disease requiring systemic antibiotics, antifungal (excluding antifungals given for nail-beds infections), or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C

Uncontrolled life-threatening infections

Active or uncontrolled infections

Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator; this includes scleroderma

Patients requiring intravenous (IV) antiviral or IV antibiotic treatment for ongoing infections

Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled or the control of which may be jeopardized by this therapy

Patients requiring IV antiviral or IV antibiotic treatment for ongoing infections

Active and uncontrolled infections, including hepatitis B or C

Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease

Concurrent opportunistic infections

Patients must not have active uncontrolled infections, other medical or psychological/social conditions that might increase the likelihood of patient adverse effects or poor outcomes

Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease

Concurrent opportunistic infections

Active infection requiring systemic treatment or any uncontrolled infections =< 14 days prior to enrollment

8. Any evidence of serious active infections.

Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).

Active infections prior to receiving study treatment or systemic infection requiring chronic maintenance or suppressive therapy

Patients with active infections, including HIV, will be excluded

Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease

Concurrent opportunistic infections

Severe infections within 28 days prior to the first dose of study treatment

Severe intercurrent infections

Concurrent serious infections requiring parenteral antibiotic therapy.

Patients with serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy

Does not have an uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable

Patients with other uncontrolled/progressing infections defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.

Any evidence of serious active infections

Active or chronic recurrent systemic infections that require continuous antimicrobial therapy during the Kevetrin study period

Active infections requiring antibiotics

Infections

Active or incompletely treated infections that could involve the device implant site.

Patients with systemic infections requiring antibiotics or chronic maintenance/suppressive therapy

Patients with uncontrolled concurrent illness, active infection requiring i.v. antibiotics, or uncontrolled infections, or a fever > 38.5°C on the day of scheduled dosing

Active systemic infections (for e.g.: requiring anti-infective treatment), coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease

Concurrent opportunistic infections

Serious, active infections must be controlled; patients may be enrolled while still on antibiotics as long as clinical signs of active infection have resolved

Chronic or current active infections requiring systemic antibiotics, antifungals or antiviral therapy

Known active infection (except fungal nail infections).

Patients with multiple CMV, EBV or adenovirus infections are eligible given that each infection is persistent despite standard therapy as defined above; patients with multiple infections with one persistent infection and one controlled infection are eligible to enroll

Uncontrolled infections; for bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment; for fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment

Active clinically serious infections of > Grade 2 and/or active infections that require treatment with systemic agent

Active infections, including opportunistic infections

Severe systemic infections, current or within the two weeks prior to initiation of AEB071.

Active (acute or chronic) or uncontrolled severe infections

Severe systemic diseases or active uncontrolled infections

Have active, acute, or chronic clinically significant infections or bleeding.

Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.

Severe infections within 4 weeks prior to Cycle 1, Day 1

Recent infections not meeting the criteria for severe infections within 2 weeks prior to Cycle 1, Day 1

Participants who have active, uncontrolled infections.

Patients with important infections requiring antibiotics are INELIGIBLE, but patients who acquire minor infections while on the study may remain on the study

Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease

Concurrent opportunistic infections

Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease

Opportunistic infections

Patients with active infections; the principal investigator (PI) is the final arbiter of the eligibility

Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator

Known active infections requiring IV antibiotic, antiviral, or antifungal therapy.

Acute infections (viral, bacterial or fungal infections requiring therapy).

Patients with active infections, including HIV, will be excluded, due to unknown effects DAC/THU on systemic immunity

Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)

Uncontrolled infection at the time of enrollment; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable

Active systemic infections requiring intravenous antibiotics

Concurrent opportunistic infections

Active systemic infections (for e.g.: requiring anti-infective treatment), coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease

Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease

Concurrent opportunistic infections

Patients with active systemic infections requiring antibiotics or chronic maintenance/suppressive therapy; once the infection in question has resolved and patient is off antimicrobial treatment, patients may participate

Uncontrolled (not being treated) infections at the time of cytoreduction

Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable

Patients with opportunistic viral infections other than CMV

Sepsis and/or acute, chronic, or ongoing infections that are currently being treated with systemic antimicrobials

Local skin infections at or near the acustimulation site

Uncontrolled infections that are not responsive to antimicrobial therapy

Local skin infections at or near the acupuncture sites or are under treatment for active systemic infection

Severe infections within 4 weeks prior to Day 1

Active clinically serious infections of > Grade 2

Active serious infections uncontrolled by antibiotics

Patients who have uncontrolled systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular or respiratory systems.

Patients with any active hepatitis infections.

Acute treatment for an infection (excluding fungal infection of the skin and sexually transmitted infections) or other serious medical illness within 2 weeks before Segment B enrollment

Local skin infections at or near the acupuncture sites or active systemic infection

Patients must have no evidence of active infections at the time of transplantation

There must be no uncontrolled active infections or medical conditions that the investigator feels will compromise the safety of the treatment and/or the assessment of the efficacy of therapy

Patient with active infections

Active and uncontrolled infections

Treatment may be given to eligible patients with a single or multiple infections; patients with multiple infections with one or more reactivation and one or more controlled infection are eligible to enroll

Patients with other uncontrolled infections; for bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment; for fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment; progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection; persisting fever without other signs or symptoms will not be interpreted as progressing infection

Patients with uncontrolled infections

Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment

Active uncontrolled bacterial, fungal, or viral infections – all prior infections must have resolved following optimal therapy

Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment

Active infections requiring systemic therapy

Active infection requiring antimicrobial treatment that would interfere with interpretation of adverse events, cutaneous reactions or efficacy. Treatment of minor concurrent infections should be limited to less than 10 days.

Evidence of severe pulmonary infections, as judged by the investigator

Subject has known or suspected HIV or other active infections requiring acute or chronic treatment with systemic antibiotics. Conditions requiring topical antibiotics are acceptable.

Patients with ongoing symptomatic dental infections

active infections of the oral cavity

Active infection (except mild upper respiratory infections)

Uncontrolled intercurrent illness including, but not limited to active infections

Patients with clinically significant active infections

Patients with known active treatment for hepatitis B and C infections

Active serious infections not controlled by antibiotics

Patients with active urinary tract infections

Patients should not have active infections or concurrent neoplastic disease except for skin cancer

Documented acute prostatitis or urinary tract infections

Active acute infection (i.e. currently treated with antibiotics); patients with chronic infections such as hepatitis B or C, mycobacterium avium or similar infections will be eligible provided they meet all other eligibility criteria

Patients with invasive fungal infections

Patients with known active treatment for hepatitis B and C infections

Clinically active hepatitis A, B, or C infections

Active infections of oral cavity

Patients with active treatment for active hepatitis B and C infections

Patients with active infections.

Severe infections within 4 weeks before randomization or therapeutic oral or IV antibiotics within 2 weeks before randomization

Active, uncontrolled infections within 7 days of study entry requiring systemic therapy.