Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NEXI-003 T cells · 1 trial · 11 indications
Frequencies of patients with treatment-emergent AEs (TEAEs)
DLTs in Cycle 1
Frequencies of patients with treatment-emergent AEs (TEAEs) by severity
Frequencies of patients with treatment-emergent AEs (TEAEs) by relationship to NEXI-003 T cells
Frequencies of patients with treatment-emergent SAEs
Frequencies of patients with treatment-emergent CRS
Frequencies of patients with treatment-emergent ICANS
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 2 x 10\^8 NEXI-003 T cells (derived from peripheral blood mononuclear cells \[PBMCs\] of the patient) administered by intravenous infusion on Day 1 of each cycle |
| Cohort 2 | EXPERIMENTAL | 2 x 10\^8 NEXI-003 T cells (derived from peripheral blood mononuclear cells \[PBMCs\] of the patient) administered by intravenous infusion on Days 1 and 8 of each cycle |
| Cohort 3 | EXPERIMENTAL | 2 x 10\^8 NEXI-003 T cells (derived from peripheral blood mononuclear cells \[PBMCs\] of the patient) administered by intravenous infusion on Days 1, 8, and 15 of each cycle |
| Cohort 4 | EXPERIMENTAL | 4 x 10\^8 NEXI-003 T cells (derived from peripheral blood mononuclear cells \[PBMCs\] of the patient) administered by intravenous infusion on Day 1, and 2 x 10\^8 NEXI-003 T cells administered by intravenous infusion on Days 8 and 15 of each cycle |
| Dose Expansion Stage | EXPERIMENTAL | Dose Expansion Stage to further define the safety and clinical activity, and to confirm the recommended Phase 2 dose of the NEXI- 003 T cell product at the dose established from the Dose Escalation Stage. |
| Name | Type | Description |
|---|---|---|
| Fludarabine | DRUG | Lymphodepletion Chemotherapy on Days -5, -4, and -3 before Cycle 1 ONLY |
| Cyclophosphamide | DRUG | Lymphodepletion Chemotherapy administered on Days -5, -4, and -3 before Cycle 1 ONLY |
| NEXI-003 T cells | BIOLOGICAL | Adoptive Cell Therapy specified dose on specified day(s) |
Inclusion Criteria: 1. The patient will be typed for HLA-A\*0201 expression as determined by high resolution sequence-based typing method. If documented HLA results are available from a previous test, the patient can be enrolled using these results after review and approval by the sponsor. 2. Patie...