Non Hodgkin Lymphoma Clinical Trial
Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL
This is a Phase 1/2a, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR20A in adult subjects with r/r B-cell NHL (Cohort A) or r/r CLL/SLL (Cohort B).
This is a multicenter, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate safety, tolerability, clinical activity, and find an appropriate dose to optimize safety and efficacy of PBCAR20A in subjects with relapsed/refractory (r/r) CD20+ Non-Hodgkin Lymphoma (NHL) or r/r Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Before initiating PBCAR20A, therapy, subjects will be administered lymphodepletion chemotherapy composed of fludarabine and cyclophosphamide. At Day 0 of the Treatment Period, subjects will receive a single intravenous (IV) infusion of PBCAR20A. All subjects are monitored during the treatment period through Day 28. All subjects who receive a dose of PBCAR20A will be followed in a separate long-term follow-up (LTFU) study for 15 years after exiting this study.
Key Inclusion Criteria
Criteria for NHL:
r/r CD20+ B-cell NHL that is histologically confirmed by archived tumor biopsy tissue from the last relapse and corresponding pathology report.
Measurable or detectable disease according to the Lugano classification.
Primary refractory disease or r/r disease after a response to 2 prior regimens.
Criteria for CLL/SLL:
Diagnosis of CD20+ CLL with indication for treatment based on the iwCLL guidelines and clinically measurable disease or SLL with measurable disease that is biopsy-proven SLL.
Previously failed/tolerant to at least 2 prior lines of systemic targeted therapy of known benefit.
Criteria for both NHL and CLL/SLL:
Study participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Study participant has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.
Key Exclusion Criteria:
Criteria for NHL:
Requirement for urgent therapy due to mass effects such as bowel obstruction, spinal cord, or blood vessel compression.
Active central nervous system (CNS) disease. A negative computed tomography (CT)/magnetic resonance imaging (MRI) is required at Screening if the study participant has a history of CNS lymphoma.
Criteria for NHL and CLL/SLL:
Active CNS disease. A negative lumbar puncture is required at Screening if the study participant has a history of CNS disease.
Previous 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.
Active uncontrolled fungal, bacterial, viral, protozoal, or other infection.
Any form of primary immunodeficiency.
History of human immunodeficiency virus (HIV) infection.
Active hepatitis B or C.
Uncontrolled cardiovascular disease.
Hypertension crisis or hypertensive encephalopathy within 3 months prior to Screening.
Presence of a CNS disorder that renders ineligible for treatment.
History of a genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman Diamond syndrome, or any other known bone marrow failure syndrome.
Received ASCT within 45 days of Screening if the study participant has met the rest of the count requirements.
Must not have received systemic corticosteroid therapy for at least 7 days prior to initiating lymphodepletion chemotherapy.
Received a live vaccine within 4 weeks before Screening.
Radiotherapy within 4 weeks determined on a case-by-case basis.
Presence of a pleural/peritoneal/pericardial catheter.
Current use of any anticoagulant or antiplatelet therapy.
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There are 5 Locations for this study
Duarte California, 91010, United States
Stanford California, 94305, United States
New York New York, 10032, United States
Cleveland Ohio, 44195, United States
Houston Texas, 77030, United States
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