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Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)

Name: Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT) — clinical trial record (NCT05322850)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 1/2

SponsorUniversity of Florida

Started2022-08-16

View on ClinicalTrials.gov ↗

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.

Amendment history 1 change detected by DataLookout

2026-09-02

Recruitment resumed after suspension

Trial Details

NCT Number	NCT05322850
Lead Sponsor	University of Florida Collaborators: Orca Biosystems, Inc.
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
Enrollment	40 participants
Start Date	2022-08-16
Primary Completion	2026-09 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2026-09-01