Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 for the treatment of CD19-expressing malignancies, which are hematologic cancers that carry the CD19 marker on their cells. It is currently in Phase 1 clinical development and is not yet approved by the FDA.
PBCAR19B is being developed by Precision BioSciences, Inc., a biopharmaceutical company whose stock trades under the ticker DTIL. The company is conducting clinical research on this investigational therapy for oncology indications.
PBCAR19B is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated for safety and efficacy in clinical trials.
PBCAR19B has been studied in a Phase 1 dose-escalation trial with the identifier NCT04649112. This completed trial enrolled 13 participants with CD19-expressing malignancies, including hematologic malignancies, and was conducted in the United States with adults aged 18 years and older.
PBCAR19B is a gene therapy designed to target CD19, a protein found on the surface of certain cancer cells. By targeting CD19, the therapy aims to direct the immune system against malignant cells that express this marker, potentially offering a treatment approach for CD19-expressing malignancies.