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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 16, 2022

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2027

Conditions
Acute Myeloid LeukemiaAcute Lymphoid LeukemiaMixed Phenotype Acute LeukemiaAcute Undifferentiated LeukemiaChronic Myeloid Leukemia in Myeloid Blast CrisisChronic Myeloid Leukemia in Lymphoid Blast Crisis (Diagnosis)Chronic Myeloid Leukemia - Accelerated Phase
Interventions
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.

Trial Locations (4)

32608

RECRUITING

University of Florida, Gainesville

33136

RECRUITING

University of Miami, Miami

33155

RECRUITING

Nicklaus Children's Hospital, Miami

33701

RECRUITING

Johns Hopkins All Children's Hospital, St. Petersburg

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Orca Biosystems, Inc.

INDUSTRY

collaborator

Florida Department of Health

OTHER_GOV

lead

University of Florida

OTHER

NCT05322850 - Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT) | Biotech Hunter | Biotech Hunter