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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04649112 | Dose-escalation Study of Safety of PBCAR19B in Participants With CD19-expressing Malignancies | PHASE1 | COMPLETED | 13 | — | — | Jun 16, 2021 | Sep 30, 2023 | Jul 26, 2024 | 7 | United States |
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