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

NCT05322850 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Orca Biosystems, Inc.

    collaborator INDUSTRY

  • Florida Department of Health

    collaborator OTHER_GOV

  • University of Florida

    lead OTHER

Principal Investigators

  • Jordan Milner, MD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-16
Primary Completion
2026-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05322850 on ClinicalTrials.gov