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

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Precision BioSciences, Inc.
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Rituximab

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