Trials / Recruiting
RecruitingNCT06551584
Phase I Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT
Phase I Trial for Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation From an HLA-Mismatched Donor (7/8) With Orca-T
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The study goal is to characterize the safety of the combination of Orca-T with dual agent GVHD prophylaxis.
Conditions
- Acute Myeloid Leukemia
- Acute Lymphoid Leukemia
- Mixed Phenotype Acute Leukemia
- Myelodysplastic Syndromes
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ORCA-T | 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. |
Timeline
- Start date
- 2025-12-01
- Primary completion
- 2026-05-01
- Completion
- 2026-12-01
- First posted
- 2024-08-13
- Last updated
- 2026-01-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06551584. Inclusion in this directory is not an endorsement.