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Also known as Allogeneic Anti-CD20 CAR T cells
PBCAR20A · 1 trial · 9 indications
The maximum tolerated dose (MTD) is the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy.
Dose-limiting toxicities (DLT) are certain Grade 3 and Grade 4 toxic reactions as defined by the protocol and CTCAE v5.0.
| Arm | Type | Description |
|---|---|---|
| Dose Level 1 of PBCAR20A CAR T cells | EXPERIMENTAL | 1 x 10\^6 chimeric antigen receptor (CAR) T cells per kg body weight. In this study, PBCAR20A, allogeneic anti-cluster of differentiation (CD20) CAR T Cells, is used to treat patients with relapsed or refractory (r/r) CD20+ Non-Hodgkin Lymphoma (NHL) or r/r Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Route of Administration: Intravenous infusion (IV) Lymphodepletion Conditioning: Lymphodepletion will be conducted several days prior to PBCAR20A infusion. A combination of fludarabine and cyclophosphamide will be used for lymphodepletion. |
| Dose Level 2 of PBCAR20A CAR T cells | EXPERIMENTAL | 240 x 10\^6 CAR T cells (flat dose) |
| Dose Level 3 of PBCAR20A CAR T cells | EXPERIMENTAL | 480 x 10\^6 CAR T cells (flat dose) |
| Name | Type | Description |
|---|---|---|
| PBCAR20A | GENETIC | Single dose of Allogeneic Anti-CD20 CAR T cells will be infused, and a classic "3+3" dose escalation will be applied. |
| Fludarabine | DRUG | Fludarabine is used for lymphodepletion (30 mg/m\^2/day, Days -5 to -3). |
| Cyclophosphamide | DRUG | Cyclophosphamide is used for lymphodepletion (500 mg/m\^2/day, Days -5 to -3). |
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 ...
PBCAR20A is an investigational gene therapy developed by Precision BioSciences, Inc. for relapsed non-Hodgkin's lymphoma. It is an allogeneic CAR T therapy designed to target the CD20 protein on B cells. It has been studied in a Phase 1 dose-escalation trial in adults with relapsed or refractory B-cell cancers.
PBCAR20A is being developed for relapsed non-Hodgkin's lymphoma, including relapsed or refractory B-cell non-Hodgkin lymphoma and small lymphocytic lymphoma. The Phase 1 study also enrolled patients with relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma. It is an investigational therapy and has not been approved for commercial use.
PBCAR20A targets CD20, a protein found on the surface of B cells. By binding CD20, the therapy is designed to direct an immune response against malignant B cells in non-Hodgkin's lymphoma and related B-cell malignancies. It is an allogeneic gene therapy, meaning the CAR T cells are derived from a donor rather than the patient.
PBCAR20A is being developed by Precision BioSciences, Inc., a biotechnology company that trades under the ticker DTIL. The company sponsored the Phase 1 dose-escalation study of PBCAR20A in patients with relapsed or refractory non-Hodgkin's lymphoma or chronic lymphocytic leukemia and small lymphocytic lymphoma.
PBCAR20A is in Phase 1 clinical development. Its single registered trial, NCT04030195, was a Phase 1 dose-escalation study evaluating the safety of PBCAR20A in subjects with relapsed or refractory non-Hodgkin's lymphoma or relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma. That trial is completed, and PBCAR20A is not FDA approved.
PBCAR20A has been studied in one clinical trial, NCT04030195, titled a dose-escalation study of the safety of PBCAR20A in subjects with relapsed or refractory non-Hodgkin's lymphoma or relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma. The Phase 1 trial enrolled 18 participants in the United States and is completed.