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

Trial ID or NCT#

NCT04030195

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and 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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Exclusion Criteria:
  1. 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.
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Investigator(s)

David Miklos
David Miklos
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist, Medical oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

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Contact

Amy Pottenger
650-736-1400

View on ClinicalTrials.gov