Gene Therapy Clinical Trials

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

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.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • genetic: PBCAR20A
  • drug: Fludarabine
  • drug: Cyclophosphamide

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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Amy Pottenger
650-736-1400
Not Recruiting