Trials / Suspended
SuspendedNCT05322850
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT) Recipients With Hematologic Malignancies (HM)
- Status
- Suspended
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- University of Florida · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
This is a first in children prospective study of allogeneic hematopoietic cell transplant using a centrally manufactured engineered donor graft (Orca-Q). The study will assess safety and efficacy of Orca-Q in pediatric patients with hematologic malignancies.
Conditions
- Acute Myeloid Leukemia
- Acute Lymphoid Leukemia
- Mixed Phenotype Acute Leukemia
- Acute Undifferentiated Leukemia
- Chronic Myeloid Leukemia in Myeloid Blast Crisis
- Chronic Myeloid Leukemia in Lymphoid Blast Crisis (Diagnosis)
- Chronic Myeloid Leukemia - Accelerated Phase
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Orca-Q | All transplant recipients enrolled on this study in both the phase I and phase II portions will receive Orca-Q (Orca-Q Prime and Orca-Q Supplement) intravenously following myeloablative conditioning. |
Timeline
- Start date
- 2022-08-16
- Primary completion
- 2026-09-01
- Completion
- 2027-09-01
- First posted
- 2022-04-12
- Last updated
- 2026-04-13
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05322850. Inclusion in this directory is not an endorsement.