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Dose-escalation Study of Safety of PBCAR20A in Subjects With r / r NHL or r / r CLL / SLL

Trial Status: Active

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 study participants with r / r B-cell NHL (Cohort A) or r / r CLL / SLL (Cohort B).

Inclusion Criteria

  • Key Inclusion Criteria* Criteria for NHL: - r/r 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 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 CLL/SLL: - Active CNS disease. A negative lumbar puncture is required at Screening if the study participant has a history of CNS disease. Criteria for NHL and CLL/SLL: - 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. - Active hemolytic anemia. - 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 1 day prior to initiating lymphodepletion chemotherapy. - Received a systemic biologic agent within 30 days or 5 half-lives. - Received a live vaccine within 4 weeks before Screening. - Received standard cytotoxic chemotherapy within 10 days of 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 criteria apply

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

This is a multicenter, nonrandomized, open-label, parallel assignment, single-dose,

dose-escalation, and dose-expansion study to evaluate the safety and tolerability, find an

appropriate dose to optimize safety and efficacy, and evaluate clinical activity of PBCAR20A

in subjects with relapsed/refractory (r/r) Non-Hodgkin Lymphoma (NHL) or r/r Chronic

Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Before initiating PBCAR20A,

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 Phase Phase I/II

Trial Type Treatment

Lead Organization
Precision BioSciences, Inc.

  • Primary ID PBCAR20A-01
  • Secondary IDs NCI-2020-00365
  • Clinicaltrials.gov ID NCT04030195