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 or r/r CLL/SLL.
Inclusion Criteria
- 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.
Additional locations may be listed on ClinicalTrials.gov for NCT04030195.
Locations matching your search criteria
United States
New York
New York
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.
Trial PhasePhase I/II
Trial Typetreatment
Lead OrganizationPrecision BioSciences
- Primary IDPBCAR20A-01
- Secondary IDsNCI-2020-00365
- ClinicalTrials.gov IDNCT04030195