Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
pCAR-19B cells · 2 trials · 3 indications
Objective response rate includes CR, CRi.
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Dose-limiting toxicity after cell infusion
| Arm | Type | Description |
|---|---|---|
| pCAR-19B cells | EXPERIMENTAL | Infusion of pCAR-19B cells by dose of 0.6-2 x106 cells/kg |
| Name | Type | Description |
|---|---|---|
| pCAR-19B cells | BIOLOGICAL | Drug: pCAR-19B cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion. |
Inclusion Criteria: 1. The patient himself or his guardian agrees to participate in this clinical trial and signs the Informed Consent Form (ICF), indicating that he understands the purpose and procedures of this clinical trial and is willing to participate in the research; 2. Diagnosed with B-ALL，...
pCAR-19B cells is an investigational cell therapy being developed for the treatment of CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) in children and adolescents. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
pCAR-19B cells is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol DTIL. The company is conducting clinical trials for this investigational therapy in pediatric patients with relapsed or refractory B-ALL.
pCAR-19B cells is currently in Phase 2 clinical development. A Phase 1 study has been completed, and a Phase 2 trial is actively recruiting participants. The therapy remains investigational and has not received regulatory approval.
pCAR-19B cells has been studied in two clinical trials. NCT04888468 was a completed Phase 1 study in 9 patients, and NCT05334823 is an ongoing Phase 2 trial with a target enrollment of 100 patients. Both trials are being conducted in China in pediatric patients with relapsed or refractory B-ALL.
pCAR-19B cells is a chimeric antigen receptor T-cell therapy targeting CD19, a protein expressed on B cells. It is designed to recognize and eliminate CD19-positive leukemia cells in patients with relapsed or refractory B-cell acute lymphoblastic leukemia.