©2022 Stanford Medicine
Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL
Not Recruiting
Trial ID: NCT04030195
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)
Stanford Investigator(s)
David Miklos
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
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.
Intervention(s):
genetic: PBCAR20A
drug: Fludarabine
drug: Cyclophosphamide
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Amy Pottenger
650-736-1400