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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05182073 | FT576 in Subjects With Multiple Myeloma | PHASE1 | COMPLETED | 31 | — | — | Nov 10, 2021 | Oct 18, 2024 | Dec 12, 2025 | 14 | United States |
| Arm | Type | Description |
|---|---|---|
| Regimens A-A4 | EXPERIMENTAL | FT576 single dose monotherapy in subjects with r/r MM |
| Regimen A1 | EXPERIMENTAL | FT576 multiple dose monotherapy in subjects with r/r MM |
| Regimens B-B4 | EXPERIMENTAL | FT576 single dose in combination with daratumumab in subjects with r/r MM |
| Regimen B1 | EXPERIMENTAL | FT576 multiple dose in combination with daratumumab in subjects with r/r MM |
| Name | Type | Description |
|---|---|---|
| FT576 (Allogenic CAR NK cells with BCMA expression) | DRUG | Experimental Interventional Therapy: FT576 comprises allogeneic natural killer (NK) cells, derived from a clonal, CD38-knockout, human-induced pluripotent stem cell line (iPSC) that expresses anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR), high-affinity, non-cleavable CD16 (hnCD16), and IL-15/IL-15 receptor fusion protein (IL-15RF). |
| Cyclophosphamide | DRUG | Conditioning Agent |
| Fludarabine | DRUG | Conditioning Agent |
| Daratumumab | DRUG | Anti-CD38 Monoclonal Antibody |
| Bendamustine | DRUG | Conditioning Agent |
* Abbreviated inclusion criteria: Diagnosis of r/r MM with measurable disease by at least one of the following: * Serum M-protein ≥1.0 g/dL * Urine M-protein ≥200 mg/24 hours * Involved serum free light chain level ≥10 mg/dL, with an abnormal kappa-lambda ratio if the serum M-protein \<1.0 g/dL an...