Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for the treatment of relapsed or refractory Non-Hodgkin's Lymphoma, as well as relapsed or refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. It is an oncology therapy developed by Precision BioSciences, Inc.
PBCAR20A is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol DTIL. The company is conducting clinical research on this investigational gene therapy for hematologic malignancies.
PBCAR20A is in Phase 1 clinical development. It is an investigational gene therapy and has not been approved by the FDA. The drug is being evaluated in an early-stage clinical trial to assess its safety and tolerability.
PBCAR20A has been studied in one clinical trial, identified as NCT04030195. This 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/Small Lymphocytic Lymphoma. The trial enrolled 18 participants in the United States.
PBCAR20A is a gene therapy that is being developed for oncology indications. The available information does not specify whether it is a CAR-T therapy or describe its mechanism of action. The drug is being studied in patients with relapsed or refractory B-cell malignancies.