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

Not Recruiting

Trial ID: NCT04030195


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)

Stanford Investigator(s)

David Miklos
David Miklos

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)


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

   - 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

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.


genetic: PBCAR20A

drug: Fludarabine

drug: Cyclophosphamide

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Amy Pottenger

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