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Also known as Allogeneic Anti-CD19 CAR T cells
PBCAR19B · 1 trial · 2 indications
To determine the maximum tolerated dose (MTD)
To assess adverse events as dose limiting toxicities as defined by the protocol and CTCAE v5.0.
| Arm | Type | Description |
|---|---|---|
| Dose Level 1 | EXPERIMENTAL | In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL). Route of Administration: Intravenous injection/infusion. |
| Dose Level 2 | EXPERIMENTAL | In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL). Route of Administration: Intravenous injection/infusion. |
| Dose Level 3 | EXPERIMENTAL | In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL). Route of Administration: Intravenous injection/infusion. |
| Name | Type | Description |
|---|---|---|
| PBCAR19B | GENETIC | Single dose of Allogeneic Anti-CD19 CAR T cells will be injected/infused |
Inclusion Criteria: * Relapsed or refractory CD19+ expressing malignancies * At least 2 prior regimens per Standard of Care Exclusion Criteria: * No history of active CNS involvement
PBCAR19B is an investigational gene therapy being studied in adults with CD19-expressing malignancies, including hematologic malignancies. It is designed for patients whose cancers express the CD19 antigen. The only clinical trial of PBCAR19B completed to date enrolled 13 participants in the United States.
PBCAR19B targets CD19, an antigen expressed on the surface of certain malignant cells in hematologic cancers. CD19 is the molecular target of the therapy, and the study population was selected for CD19-expressing malignancies. This target-directed approach is intended to focus the therapy on CD19-positive cancer cells.
PBCAR19B is being developed by Precision BioSciences, Inc., which trades on the Nasdaq under the ticker DTIL. The company is the sponsor of the clinical program evaluating PBCAR19B in CD19-expressing malignancies.
PBCAR19B is in Phase 1 clinical development. It is an investigational gene therapy and has not been approved by the FDA. The Phase 1 dose-escalation study of PBCAR19B has been completed, with no active trials currently listed for the program.
PBCAR19B has been evaluated in one clinical trial, NCT04649112, titled a dose-escalation study of safety of PBCAR19B in participants with CD19-expressing malignancies. The Phase 1 trial enrolled 13 adults aged 18 years and older in the United States and is now completed.