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
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: Yes
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.
Investigator(s)
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)
Contact us to find out if this trial is right for you.
Contact
Amy Pottenger
650-736-1400
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