Trial Search Results

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

PBCAR20A is an allogeneic antihuman-cluster of differentiation (CD) 20 chimeric antigen receptor (CAR)T-cell product derived from qualified donor T cells that have been genetically edited to remove theexpression of the endogenous T-cell receptor (TCR). The primary objective of this study is to evaluate the safety and tolerability of PBCAR20A, an allogeneicanti-CD20 chimeric antigen receptor (CAR) T cell investigational product, in study participants withrelapsed/refractory (r/r) cluster of differentiation (CD) 20-positive (CD20+) non-Hodgkin lymphoma (NHL)or r/r CD20+ Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) and find anappropriate dose to optimize safety and efficacy.The secondary objective is to evaluate the clinical activity and safety profile of PBCAR20A in studyparticipants with r/r CD20+ NHL or r/r CD20+ CLL/SLL.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Precision BioSciences, Inc.

Stanford Investigator(s):

Intervention(s):

  • Genetic: PBCAR20A
  • Drug: Fludarabine
  • Drug: Cyclophosphamide

Phase:

Phase 1/Phase 2

Eligibility


Key Inclusion Criteria*

Criteria for NHL:

   - r/r 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 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 CLL/SLL:

   - Active CNS disease. A negative lumbar puncture is required at Screening if the study
   participant has a history of CNS disease.

Criteria for NHL and CLL/SLL:

   - 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.

   - Active hemolytic anemia.

   - 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 1 day prior to
   initiating lymphodepletion chemotherapy.

   - Received a systemic biologic agent within 30 days or 5 half-lives.

   - Received a live vaccine within 4 weeks before Screening.

   - Received standard cytotoxic chemotherapy within 10 days of 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.

      - Additional criteria apply

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