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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04416984 | Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2) | PHASE1 | ACTIVE NOT_RECRUITING | 160 | — | — | May 21, 2020 | May 1, 2029 | Mar 4, 2026 | 29 | United States, Australia +1 |
Dose limiting toxicity is defined as protocol-defined ALLO-501A-related adverse events with onset within 28 days following infusion
DLT is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion
ORR defined as assessment of CR and PR using Lugano classification criteria 2014
| Arm | Type | Description |
|---|---|---|
| ALLO-501A, ALLO-647 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ALLO-501A | GENETIC | ALLO-501A is an allogeneic CAR T cell therapy targeting CD19 |
| ALLO-647 | BIOLOGICAL | ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen |
| Fludarabine | DRUG | Chemotherapy for lymphodepletion |
| Cyclophosphamide | DRUG | Chemotherapy for lymphodepletion |
Inclusion Criteria: For subjects with LBCL: * Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse per WHO 2017 * At least 1 measurable lesion at time of enrollment * Relapsed or refractory disease after at least 2 lines of chemotherapy * Absence of signi...