Use of any investigational product within 4 weeks prior to randomization
Patients whose apheresis product were to be further selected and purified
Active, known, clinically serious infections within the 14 days prior to first dose of investigational product
Prior history of anaphylaxis with this product type
Agree to use condoms until 30 days following the last dose of investigational product, or
Subject has received treatment with any investigational immunotherapy within 2 years prior to study screening or has received treatment with any other investigational product within 28 days prior to study screening
Subject who has been treated with an investigational product and has not completed the entire follow-up period for that investigational product;
Treatment with any investigational product within 28 days prior to Screening.
Radiation therapy within 4 weeks of investigational product.
Cytotoxic chemotherapy within 4 weeks of investigational product (6 weeks for mitomycin C or nitrosoureas) if immediate prior regimen was administered on an every 3 4 week schedule or 2 weeks of investigational product if immediate prior regimen consisted of weekly therapy.
Any other anti cancer agents (eg, hormonal, biological, investigational) within 5 times the half life prior to investigational product.
Subjects who have participated in a clinical trial within 30 days of Screening or are scheduled to receive an investigational product.
Previous investigational product (IP) assignment in the present study
Administration of another investigational medicinal product within 30 days before the screening period.
Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational medicinal product (IMP) within ? 5 x the half-life of the IMP prior to day 1 cycle 1 of Minnelide.
Have received or are receiving an investigational medicinal product (IMP) or other systemic anticancer treatment within 2 weeks prior to the first dose of study treatment
Participating in any other clinical trials using an investigational product.
Treatment with any small molecule investigational medicinal product (IMP) within 28 days prior to first dose
investigational product AGS-16C3F and/or,
Known allergy or hypersensitivity to investigational product (IP) or any excipient
Patients who are currently participating in any other clinical trial of an investigational product
Hemoglobin >= 8.0 g/dL within first 2 weeks prior to first dose of investigational product
Patients who are currently participating in any other clinical trial of an investigational product
The subject must have no measurable disease at the time of investigational product administration\r\n* The subject must complete all prior surgery requiring general anesthesia at least four (4) weeks before administration of the investigational product; the subject must complete all surgery requiring local/epidural anesthesia at least seventy-two (72) hours prior to administration of the investigational product\r\n* The subject must complete all prior systemic chemotherapy therapy, and all adverse events have either returned to baseline or have stabilized at least four (4) weeks prior to administration of the investigational product\r\n* The subject must complete all prior systemic radiation therapy at least four (4) weeks prior to administration of the investigational product; the subject must complete all prior focal radiation therapy at least two (2) weeks prior to the administration of the investigational agent; the subject must not have received a radiopharmaceutical within eight (8) weeks prior to the administration of the investigational product\r\n* The subject may continue hormonal therapy (i.e. tamoxifen, anastrozole) during the study
The subject has a history of anaphylaxis or other serious adverse reactions relating to administration of any components of the investigational product
Treatment with an investigational product during the last 2 weeks
Requiring blood product support
Receipt of radiation therapy within 4 weeks prior to starting investigational product, or limited field of radiation for palliation within 2 weeks of the first dose of investigational product
Requiring blood product support
Intolerance to the investigational product or its excipients, or any condition that would significantly impair and/or prohibit the patient's participation in the study, as per the Investigator's judgment.
Current or recent treatment with any other investigational medicinal product or device
Received an investigational product or been treated with an investigational device within 30 days prior to first drug administration, or plans to start any other investigational product or device study within 30 days after last drug administration.
Use of any investigational product within 4 weeks prior to randomization
Has received a T-cell product within 6 weeks prior to planned infusion of genetically modified T cells.
Requiring blood product support
Requiring ongoing blood product support at time of pre-registration
Requiring blood product support
Research product must pass all release tests
Use of any investigational product within 30 days prior to randomization
Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used)
Investigational medicinal product within the last 30 days prior to screening
Investigational medicinal product within the last 30 days prior to screening
Treatment with any investigational product within < 4 half-lives for each individual investigational product OR 28 days prior to randomization
Patient has an investigational medicinal product within the last 30 days prior to screening.
Male subjects must refrain from donating sperm starting at the planned first dose of investigational product (IP) until 30 days following the last dose of IP
Had chemotherapy or radiotherapy within 4 weeks prior to the first day of Investigational Product (IP) administration.
Participation in a therapeutic investigational study within 4 weeks prior to enrollment, or anticipated treatment with another investigational product while on study; this refers to non-commercially approved investigational drugs different than those used in this protocol
Patients on immunosuppressants, systemic corticosteroids, or any other investigational product.
Known allergy or hypersensitivity to Investigational Product.
Current, or recent (within 30 days, or 5 half-lives of investigational product) participation in other clinical trials of investigational agents and/or containing interventional procedures deemed contrary to the objectives and conduct of this trial.
Use of any investigational product or investigational medical device within 28 days prior to enrollment
Patient who will be receiving another investigational product during the study
No treatment with an investigational product or device within 21 days of cycle 1 day 1
The patient has received therapeutic dose chemotherapy or radiotherapy ? 21 days prior to start of Investigational Product.
The patient has received maintenance dose chemotherapy (e.g., low dose cyclophosphamide) ? 7 days from the first dose of Investigational Product.
The patient has received any investigational therapy ? 28 days prior to start of Investigational Product. Investigational therapy is defined as any medicinal product that is not approved in the country of treatment for any indication, adult or pediatric.
The patient has received any biological therapy ? 7 days prior to the start of Investigational Product, or monoclonal antibody ? 3 half-lives or 28 days, whichever is shorter, prior to the first dose of Investigational Product.
Concurrent use of any other investigational product
Treatment with an investigational product or device within 21 days of cycle 1 day 1
Patients who have received another investigational product within the longer of 14 days or 5 half-lives of the previous product
DONOR: Alternatively to a fresh unmodified leukapheresis product, previously collected cryopreserved peripheral blood stem cells (PBSC) after mobilization with G-CSF or cryopreserved unmodified leukapheresis product from the original donor can be used; if cryopreserved product is not available, the following criteria apply for the DLI product:
Exposure to an investigational product or investigational device in another clinical study within 4 weeks prior to C1D1, or is scheduled to participate in another clinical study involving an investigational product or device during the course of this study
Understand that the (investigational Product) IP could have a potential teratogenic risk.
Prior treatment with any investigational product within the past 4 weeks
All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product; if the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study
Subjects receiving any other investigational medicinal product or anti-cancer therapy.
The subject has received an investigational product within the following time period prior to the first dosing day in the current study: 28 days or 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is warranted by the data).
Received an investigational product within 28 days of study treatment or planned to receive within 28 days after vaccine administration
The patient has received any investigational or non-registered medicinal product other than the study treat-ment within 30 days preceding the first dose of study treatment or plans to receive such a drug during the study period.
The patient has received any investigational or non-registered medicinal product other than the study medi-cation within 30 days preceding the first dose of study medication or plans to receive such a drug during the study period.
Other investigational product-concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited
Other medications that might interfere with the evaluation of the investigational product
Other investigational product — concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited
Other medications that might interfere with the evaluation of the investigational product
Known or suspected hypersensitivity to any of the constituents of the investigational product
Subjects must be willing to undergo a cystoscopy on study for investigational product removal.
Subjects who have received radiotherapy to the pelvis and/or sternum within one year of first Investigational Product administration
Subjects who have had a venous or arterial embolic event AND who have received anti-coagulant treatment, where both the event and the treatment were within six months of the first Investigational Product administration
Subjects who have received treatment with an investigational agent within 30 days of the projected first administration of Investigational Product (Day 0)
Less than 30 days since receipt of any investigational product or device. Investigational use/receipt of a medicinal product or device that has been approved by the country's local regulatory authority for any indication is permitted.
RECIPIENT: Other investigational product – concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited
RECIPIENT: Other medications that might interfere with the evaluation of the investigational product
Administration of any blood product within 3 months of enrollment
Participation in a trial of an investigational medicinal product within the previous 28 days
Known clinically-significant doubling in marrow or perIP (INVESTIGATIONAL PRODUCT) heral blood blast percentage (to ? 20%) in the 8-week period leading to the first dose of IP (INVESTIGATIONAL PRODUCT) (Cycle 1, Day 1)
Use of any of the following within 28 days prior to the first dose of IP (INVESTIGATIONAL PRODUCT):
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered product to treat the subject's underlying disease, is allowed.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. NOTE: Subjects enrolled in this study may also be eligible for a four-year gynaecological follow-up of the HPV-015 study, in which no investigational product will be administered. Subjects will be invited to the gynaecological follow-up study if either of the following applies:
Subject has previously received VM110, or any other investigational product in the past thirty days
TOBACCO PRODUCT USERS
testing on site at the institution (urine or serum ßHCG) within 24 hours prior to the start of investigational product administration
Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments
Agrees not to receive any other investigational product or therapy while participating in this study.
Has received an investigational product within the 30 days prior to Lymphoseek administration
Patients with the use of any investigational product or device, excluding fluorodopa (F-DOPA) scans, within 30 days prior to dosing
May have received treatment with an investigational product.
Treatment with any investigational product within 30 days before the first infusion.