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.
Study sponsor and potential other locations can be found 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