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A Phase 1 Study of PBCAR19B in Subjects with CD19-expressing Malignancies
PBCAR19B-01 is a Phase 1, first-in-human study of PBCAR19B designed to evaluate the safety and tolerability of PBCAR19B in subjects with relapsed/refractory Non Hodgkin Lymphoma (r/r NHL) and find an appropriate dose to optimize safety and efficacy.
- Subject has an Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
- Measurable or detectable disease (positron emission tomography-positive) with evidence of disease progression after most-recent therapy according to the Lugano classification.
- Subject has adequate bone marrow, renal, hepatic, pulmonary and cardiac function.
- Subject has had a malignancy, besides the malignancies of inclusion (B-cell NHL or CLL/SLL), that in the investigator's opinion, has a high risk of relapse in the next 2 years.
- Recent clinically significant fungal, bacterial, viral, protozoal, or other infection must be resolved and not requiring therapeutic anti-microbial medications at least 7 days prior to lymphodepletion.
- Any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease).
This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety and clinical activity of PBCAR19B in adults with r/r NHL.
Before initiating the study drug, PBCAR19B, all subjects will be administered lymphodepletion chemotherapy.
On Day 0 of the Treatment Period, subjects will receive an injection or intravenous (IV) infusion of PBCAR19B.
All subjects are monitored for adverse effects (AE) during the treatment period through Day 28. All subjects will be monitored for AEs, at minimum, daily on days 0-7, every other day on days 8-14, and 2 times per week until day 28. This can be accomplished without a full study visit, but assessment of new AEs must be done at these intervals. Additionally, vital signs, laboratory testing, and other assessments may be performed as clinically indicated. All subjects will be followed until death, early discontinuation due to disease progression, stem cell transplant, withdrawal due to intolerable toxicity, withdrawal of consent, or Day 360, whichever occurs first. All subjects who receive a dose of PBCAR19B will be followed in a separate long-term follow up (LTFU) study after exiting this study (due to either discontinuation or completion).