Dose-escalation Study of Safety of PBCAR0191 in Patients With r/r NHL and r/r B-cell ALL

Conditions:Blood Cancer, Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:March 11, 2019
End Date:June 2021
Contact:Clinical Precision BioSciences, Inc.

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Phase 1/2a, Open-label, Dose-escalation/Expansion, Parallel Assignment Study to Evaluate Safety and Clinical Activity of PBCAR0191 in Subjects With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma and r/r B-cell Acute Lymphoblastic Leukemia

To evaluate the safety and tolerability, find an appropriate dose to optimize safety and
efficacy, and evaluate clinical activity of PBCAR0191 in subjects with relapsed/refractory
(r/r) B-cell acute lymphoblastic leukemia (B-ALL) and non-Hodgkin lymphoma (NHL).

Key Inclusion Criteria*

- Adult patients ≥ 18 years.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

- Subject has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.

Criteria for B-ALL:

- Relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia (B-ALL).

- Philadelphia chromosome positive (Ph+) disease can be eligible if they are intolerant
to tyrosine kinase inhibitor (TKI) therapy or if they have relapsed/refractory

Criteria for NHL:

- r/r CD19+ B-cell NHL that is histologically confirmed by archived tumor biopsy tissue
from last relapse and corresponding pathology report.

- Received at least 2 prior chemotherapy-containing regimens.

- Measurable or detectable disease according to the Lugano Classification.

Key Exclusion Criteria*

- Active hepatitis B or C.

- Active GvHD symptoms.

- C-reactive protein (CRP) >15 mg/dL at screening.

- History of concomitant genetic syndrome known bone marrow failure syndrome.

- Presence of pleural/peritoneal/pericardial catheter.

- Received stem cell transplant within 90 days before screening.

- Received blinatumomab or inotuzumab ozogamicin within 30 days of screening.

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

- Radioimmunotherapy within 6 months before screening that may interfere with the
activity of agents in the study.

- Received an anti-PD-1 or anti-PD-L1 antibodies, or other immune modifying therapy.

Criteria for B-ALL:

- Burkitt cell (L3 ALL) or mixed-lineage acute leukemia.

- Evidence of CNS leukemia.

Criteria for NHL:

- Active hemolytic anemia.

- Active CNS lymphoma.

- Additional criteria apply
We found this trial at
Duarte, California 91010
Phone: 626-218-1133
Duarte, CA
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Tampa, Florida 33612
Tampa, FL
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