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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06551584 | Phase I Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT | PHASE1 | RECRUITING | 24 | — | — | Dec 1, 2025 | Dec 1, 2026 | Jan 30, 2026 | 1 | United States |
The proportion of patients who, at Day +100 have not experienced any severe transplant-related adverse events including non-relapse mortality (NRM), primary graft failure, acute GVHD (grade 2-4), acute GVHD grade 3-4, or opportunistic infections (grade 4-5).
| Arm | Type | Description |
|---|---|---|
| ORCA-T + (tacrolimus and ruxolitinib) | EXPERIMENTAL | Dual-agent tacrolimus starting on the day after Tcon infusion (Day +3 or Day +4) and ruxolitinib starting on the day after tacrolimus (Day +4 or Day +5). |
| Name | Type | Description |
|---|---|---|
| ORCA-T | DRUG | On Day 0, participants will receive an infusion of Orca-T HSPCs and Orca-T Tregs. On Day +2 or +3 (between approximately 48 to 72 hours of Day 0), patients will receive an infusion of the Orca-T Tcons. There is no dose escalation or de-escalation planned for the Orca-T investigational product. |
Inclusion Criteria: 1. Eligible diseases: * Acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) as defined in Section 6.1.3; with or without the presence of known minimal residual disease, or * Myelodysplasic syndrom...