Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Allo-QuadCAR01-T · 1 trial · 4 indications
Incidence and intensity of adverse events (AEs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for cytokine release syndrome (CRS), immune effector cell associated neurotoxicity syndrome (ICANS), tumor lysis syndrome, and graft versus host disease (GvHD), which will be graded according to widely accepted specialized criteria
MTD
Incidence of DLTs
Complete remission rate is defined as the proportion of participants with complete remission, per international working group (IWG) Lugano classification, as assessed by the investigator.
| Arm | Type | Description |
|---|---|---|
| Allo-QuadCAR01-T | EXPERIMENTAL | Phase Ia (Escalation): Participants with relapsed or refractory B-cell malignancies will receive lymphodepleting chemotherapy followed by a single infusion of Allo-QuadCAR01-T. Phase Ib (Expansion): After dose escalation, additional participants with relapsed or refractory B-cell lymphoma will receive lymphodepleting chemotherapy followed by a single infusion of Allo-QuadCAR01-T at one or more tolerable dose levels from Phase Ia. Phase II: Participants with relapsed or refractory DLBCL will receive lymphodepleting chemotherapy, followed by a single infusion of Allo-QuadCAR01-T at the recommended Phase II dose. The primary endpoint is complete response rate at Week 13, with secondary endpoints including duration of response, progression-free survival, and overall survival. |
| Name | Type | Description |
|---|---|---|
| Cyclophosphamide (Non-IMP, Lymphodepletion) | OTHER | Intravenous infusion over 3 days (d-5 to d-3) |
| Fludarabine (Non-IMP, Lymphodepletion) | OTHER | Intravenous infusion over 3 days (d-5 to d-3) |
| Allo-QuadCAR01-T | DRUG | Single dose IV infusion on Day 1 |
Inclusion Criteria: * Adults 18 years or older. * Diagnosed with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukemia (CLL). * Must have received at least 2 prior lines of therapy. * ECOG performance status 0-1 (able to carry out daily activities). * Adequate o...