Patients must not have a known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is untreated and/or with a detectable viral load
Patients with known hepatitis B or hepatitis C are not eligible, regardless of concomitant antiretroviral therapy or current viral load
Patients with known human immunodeficiency virus (HIV) disease taking antiretroviral therapy are excluded\r\n* Patients with known chronic active hepatitis B (defined as a positive hepatitis B surface antigen and/or hepatitis B viral load in the last months) are excluded, regardless of antiviral treatment
Have a viral load < international units/milliliter (IU/mL).
Patients with known active hepatitis (i.e., hepatitis B or C) or human immunodeficiency virus (HIV) with detectable viral load (history of HIV with undetectable viral load is allowed)
Active hepatitis C (defined as a positive HCV viral load)
Must be on a multi-drug anti-HIV regimen (excluding zidovudine [AZT, ZDV, Retrovir], or agents containing zidovudine [e.g., Combivir and Trizivir], and efavirenz [Sustiva], or agents containing efavirenz [e.g., Atripla]), and have an HIV- viral load < copies/mL by reverse transcriptase-polymerase chain reaction (RT-PCR) within months prior to study enrollment; for patients who have had negative viral loads in the past months and no known HIV viral load (VL) > copies/mL within the past months, minor fluctuations of viral load (isolated escalations up to copies/mL) are acceptable; the participant's history of negative viral loads may be documented with recent laboratory results and/or a record from the participant's HIV care provider; participants on zidovudine [AZT, ZDV, Retrovir; including Combivir and Trizivir] and efavirenz [Sustiva; including Atripla] must switch to an alternative regimen without anticipated drug-drug interactions or myelosuppressive properties based on known viral resistance patterns and/or ART history, such as raltegravir and Truvada (emtricitabine and tenofovir) at least two weeks prior to the transplant
Participants with hepatitis B should be on appropriate anti-viral therapy at the time of the transplant, and their viral load should be negative; timeline: within weeks prior to enrollment
Known seropositive for or positive viral load for human immunodeficiency virus (HIV) or positive viral loads for infectious hepatitis, type B (HBV) or C (HCV)
Obtained within days prior to CD: HBV viral load negative
Patients with a positive hepatitis B core antibody (HBVcAb) must have negative viral load measurement
HIV or hepatitis C - presence of viral load
CD count < cells/ml and detectable viral load within the least months (HIV infected participants
Active Hepatitis B or C determined by a detectable viral load of HBV or HCV.
Patients with known hepatitis B or C virus (hepatitis B virus [HBV] or hepatitis C virus [HCV]) infection are eligible provided liver function parameters meet laboratory eligibility criteria\r\n* Patients with active HBV infection must have monitoring of viral load and demonstrate adequate treatment with appropriate antiviral therapy according to institutional practice\r\n* Patients with active HCV infection must have monitoring of liver function tests and viral load if indicated according to institutional practice
Known infection with human immunodeficiency virus (HIV); hepatitis B is allowed only if viral load is undetectable and if on anti-hepatitis B therapy like entecavir; hepatitis C is allowed only if viral load is undetectable, and if the patient has received curative therapy
Patients with successfully treated hepatitis C virus (HCV) are eligible if HCV viral load is undetectable
Key Inclusion Criteria:\n\n Up to prior regimens for MCL. Prior therapy must have included:\n\n - Anthracycline or bendamustine-containing chemotherapy and\n\n - Anti-CD monoclonal antibody therapy and\n\n - Ibrutinib or acalabrutinib\n\n At least measurable lesion\n\n Platelet count ? ,/uL\n\n Creatinine clearance (as estimated by Cockcroft Gault) > mL/min\n\n Cardiac ejection fraction ? %, no evidence of pericardial effusion as determined by an\n ECHO, and no clinically significant ECG findings\n\n Baseline oxygen saturation >% on room air.\n\n Key Exclusion Criteria:\n\n - Known history of infection with HIV or hepatitis B (HBsAG positive) or hepatitis C\n virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the\n viral load is undetectable per standard serological and genetic testing\n\n - History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia,\n cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or\n any autoimmune disease with CNS involvement\n\n - Presence of fungal, bacterial, viral, or other infection that is uncontrolled or\n requiring IV antimicrobials for management.
Known active hepatitis, type B or C; patients on suppressive therapy with a negative viral load and no evidence of hepatic damage are eligible
Patients with treated hepatitis virus infections (hepatitis B or hepatitis C) are eligible if they have been definitively treated for months, have no detectable viral load on quantitative PCR, and liver function tests (LFTs) meet eligibility requirements
Patients with hepatitis B virus (HBV) viral load > IU/mL (antiviral therapy per local practice is required)
CELL PROCUREMENT: Patients with the following systemic viral infections will be excluded: active human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV), hepatitis B virus (HBV), hepatitis C virus (HCV) (tests can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells); Note: to meet eligibility subjects are required to be negative for HIV antibody or HIV viral load, negative for HTLV and antibody or polymerase chain reaction (PCR) negative for HTLV and , negative for hepatitis B surface antigen, or negative for HCV antibody or HCV viral load
LYMPHODEPLETION: Patients with the following systemic viral infections will be excluded: active HIV, HTLV, HBV, HCV; Note: To meet eligibility subjects are required to be negative for HIV antibody or HIV viral load, negative for HTLV and antibody or PCR negative for HTLV and , negative for hepatitis B surface antigen, or negative for HCV antibody or HCV viral load
Known hepatitis B or hepatitis C infection; EXCEPTION: if viral load < , IU/L
Has an active infection requiring systemic therapy; exception HIV on antiretrovirals with negative viral load
PRIOR TO CELL PROCUREMENT: Active infection with human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV), hepatitis C virus (HCV) (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) defined as not being well controlled on therapy; patients are required to have negative HIV antibody or negative HIV viral load, negative HTLV and antibodies, negative HCV antibody or viral load
PRIOR TO CELL PROCUREMENT: Patients who are positive for hepatitis B surface antigen are excluded; patients who are hepatitis B surface antigen negative but hepatitis B core antibody positive must have their hepatitis B viral load checked; these subjects will be excluded if their viral load is positive at baseline; subjects who are core antibody positive and viral load negative at baseline will be considered eligible
PRIOR TO LYMPHODEPLETION: Patients who are hepatitis B surface antigen positive are ineligible; patients who are hepatitis B surface antigen negative but hepatitis B core antibody positive must have their hepatitis B viral load checked; these subjects will be excluded if their viral load is positive; subjects who are core antibody positive and viral load negative will be considered eligible; subjects who are hepatitis B virus (HBV) core antibody positive and HBV viral load negative prior to lymphodepletion must have initiated anti-HBV prophylaxis prior to lymphodepletion
PRIOR TO LYMPHODEPLETION: Active infection with HIV, HTLV, HCV (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) defined as not being well controlled on therapy; patients are required to have negative HIV antibody or negative HIV viral load, negative HTLV and antibodies, negative HCV antibody or viral load
PRIOR TO LYMPHODEPLETION: Patients who are positive for hepatitis B surface antigen are excluded; patients who are hepatitis B surface antigen negative but hepatitis B core antibody positive must have their hepatitis B viral load checked; these subjects will be excluded if their viral load is positive at baseline; subjects who are core antibody positive and viral load negative at baseline will be considered eligible if the subject has initiated an anti-HBV prophylaxis regimen prior to lymphodepletion
PRIOR TO INFUSION OF ATLCAR.CD CELLS: Active infection with HIV, HTLV, HCV (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) defined as not being well controlled on therapy; patients are required to have negative HIV antibody or negative HIV viral load, negative HTLV and antibodies, negative HCV antibody or viral load
PRIOR TO INFUSION OF ATLCAR.CD CELLS: Patients who are positive for hepatitis B surface antigen are excluded; patients who are hepatitis B surface antigen negative but hepatitis B core antibody positive must have their hepatitis B viral load checked; these subjects will be excluded if their viral load is positive at baseline; subjects who are core antibody positive and viral load negative at baseline will be considered eligible; these subjects must be receiving antiviral prophylaxis initiated prior to lymphodepletion
Evidence of active infection by hepatitis B and/or C; for patients with hepatitis B treated with anti-virals to undetectable viral load, and for patients with hepatitis C with undetectable ribonucleic acid (RNA) levels and no evidence of liver damage, enrollment may be considered and should discuss first with studys principal investigator
Have received a diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C (patients who are hepatitis C antibody positive may be enrolled if they are confirmed with negative viral load at screening)
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Have received a diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C (patients who are hepatitis C antibody positive may be enrolled if they are confirmed with negative viral load at screening)
Stable, continuous antiretroviral treatment, defined as a multi-drug regimen (excluding zidovudine, also known as azidothymidine [AZT], Retrovir) prior to enrollment, as demonstrated by HIV plasma viral load < copies/mL
Patients with a history of hepatitis C, but have a negative viral load, are eligible
Patients with known active hepatitis C virus (HCV) infection; patients with a history of HCV infection who received definitive therapy and has an undetectable viral load by PCR would be eligible
Patients with PRIMARY HEPATIC CANCER must have an undetectable viral load for Hepatitis B and C.
HIV plasma viral load < copies/ml
Patients with known hepatitis B or hepatitis C infection must have viral load < , IU/L within days prior to registration
Subject with a known history of active chronic HIV, hepatitis B or hepatitis C infections; negative hepatitis C viral load is allowed
Patients with known hepatitis B or hepatitis C infection may be eligible providing they have viral load < , IU/L within days prior to registration
Patients with treated hepatitis virus infections (hepatitis B or hepatitis C) are eligible if they have been definitively treated for months, have no detectable viral load on quantitative PCR, and liver function tests (LFTs) meet eligibility requirements
HBV viral load (VL) < IU/mL (approximately cps/mL)
Additional patients at the discretion of the investigator The management guidelines, in Section , are provided according to the results of the baseline assessment of viral load and serological markers for hepatitis B. Screening for hepatitis C Patients with any of the following risk factors for hepatitis C should be tested using quantitative RNA-PCR:
Participants with active viral hepatitis (positive hepatitis B surface antigen [HepB sAg], positive HepB core antibody [Ab] with positive hepatitis B [HepB] viral load, or positive hepatitis C [HepC] antibody with positive HepC viral load)
Seronegative for hepatitis B antigen, positive hepatitis B tests can be further evaluated by confirmatory tests (hepatitis B [Hep B] deoxyribonucleic acid [DNA] quantitative [Quant], hepatitis B virus [HBV] viral load), and if confirmatory tests are negative, the patient can be enrolled
A diagnosis of active hepatitis B or C as defined by detectable viral load assays in the blood
Have received a diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C (patients who are hepatitis C antibody positive may be enrolled if they are confirmed with negative viral load at screening)
Active human immunodeficiency virus (HIV) or hepatitis B or C with positive viral load, requiring anti-viral therapy
Hepatitis B with positive viral load prior to transplant conditioning or hepatitis C virus
Active infections including hepatitis B and hepatitis C; definition of active hepatitis C infection include:\r\n* Positive hepatitis C virus (HCV) ribonucleic acid (RNA) viral load by quantitative polymerase chain reaction (PCR) testing or if negative HCV RNA viral load BUT on antiviral treatment\r\n* Liver biopsy with pathologic evidence of \r\n** Necrosis and inflammation around the portal areas - piecemeal necrosis or interface hepatitis or necrosis of hepatocytes and focal inflammation in the liver parenchyma\r\n** Inflammatory cells in the portal areas (\portal inflammation\)\r\n** Fibrosis, with early stages being confined to the portal tracts, intermediate stages being expansion of the portal tracts and bridging between portal areas or to the central area, and late stages being frank cirrhosis characterized by architectural disruption of the liver with fibrosis and regeneration
Known HIV or hepatitis B/C infection (testing not required). Subjects who are hepatitis C antibody positive may be enrolled if they are confirmed to have a negative viral load at screening.
All participants must be on antiretroviral therapy for HIV infection with CD count > /mm^ and viral load < copies/mL; participants must be on a stable antiretroviral therapy (ART) regimen that includes at least three agents, as defined below\r\n* If antiretroviral regimen contains zidovudine or strong cytochrome P, family , subfamily A, polypeptide (CypA) inhibitors (e.g. ritonavir or cobicistat-boosted protease inhibitors) and viral load is suppressed (as measured by HIV viral load =< /mL), then antiretroviral therapy must be adjusted to a less toxic therapy not containing these antivirals and must demonstrate stability for at least weeks prior to enrollment\r\n* If on antiviral therapy with zidovudine or protease inhibitors, and viral load is not suppressed (as measured by HIV viral load > copies/mL), then antiretroviral therapy must be adjusted to a less toxic regimen allowing for optimal viral suppression and must demonstrate stability for at least weeks prior to enrollment\r\n* Allowable antiretrovirals include nucleoside or nucleotide inhibitors other than zidovudine, non-nucleoside reverse transcriptase inhibitors including efavirenz, etravirine, rilpivirine, and nevirapine, integrase inhibitors raltegravir or dolutegravir, or entry inhibitors maraviroc or enfuvirtide
Hepatitis C (HCV) virus with detectable viral load or immunological evidence of chronic active disease or receiving/requiring antiviral therapy.
An indeterminate or positive test for antibody to hepatitis C virus (HCV), unless documented to have no detectable viral load on two independent samples.
For patients with hepatocellular carcinoma secondary to hepatitis B or C, test results should be indicative of chronic viral hepatitis infection:\r\n* Patients with hepatitis B\r\n** Antibodies: Hepatitis B surface antigen (HepBsAg) and hepatitis B core antibody (HepBcAb) should be elevated and hepatitis B surface antibody (HepBsAb) and hepatitis Be antibody (HepBeAb) low, indicating chronic infection; if the pattern is different from this, please notify the PI\r\n** Viral load: COBAS TaqMan test measuring hepatitis B virus (HBV) DNA is reduced in chronic phase hepatitis B; the baseline value as the patient enters this study will be useful to discriminate between drug, disease progression, or increased viral load as possible attributions for worsening symptoms\r\n* Patients with hepatitis C\r\n** Antibodies: Anti-hepatitis C virus (HCV) testing-specific tests used will be based on the sites standard procedure for identifying hepatitis C\r\n** Viral load: HCV-RNA should be relatively constant in chronic phase of disease, though the level is typically higher than in the acute phase; the baseline value as the patient enters this study will be useful to discriminate between drug, disease progression, or increased viral load as possible attributions for worsening symptoms
Patients with known hepatitis B or hepatitis C infection may be eligible providing they have viral load < , IU/mL within days prior to registration
Viral load has decreased by >= . logs or viral load < copies/ml plasma on HAART therapy
Active infection with Epstein-Barr virus (EBV) as defined as EBV viral load >= , copies per mL of whole blood; EBV viral load testing is only required if the patient has clinical signs or symptoms suggestive of active EBV infection
Active infection with human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV), hepatitis B virus (HBV), hepatitis C virus (HCV) (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells); active infection is defined as not being well controlled on therapy (Note: to meet eligibility subjects are required to be negative for HIV antibody or HIV viral load, negative for HTLV and antibody, negative for hepatitis B surface antigen, or negative for HCV antibody or HCV viral load)
Patients with a known history of hepatitis C (HCV) will be eligible if they have an undetectable viral load; if the patient received treatment for HCV, then that treatment must have been completed at least three weeks prior to enrollment