Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04030195 | Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL | PHASE1 | COMPLETED | 18 | — | — | Mar 24, 2020 | Jun 24, 2021 | Jan 31, 2023 | 5 | United States |
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 ...