Status:
COMPLETED
Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL
Lead Sponsor:
Precision BioSciences, Inc.
Conditions:
Non-Hodgkin's Lymphoma, Relapsed
Chronic Lymphoid Leukemia in Relapse
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
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 appropria...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04030195
Start Date
March 24 2020
End Date
June 24 2021
Last Update
January 31 2023
Active Locations (5)
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1
City of Hope
Duarte, California, United States, 91010
2
Stanford University
Stanford, California, United States, 94305
3
Columbia University
New York, New York, United States, 10032
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195