RecruitingPhase 1Phase 2NCT05322850

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)


Sponsor

University of Florida

Enrollment

40 participants

Start Date

Aug 16, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This Phase I/II study tests a specially engineered stem cell transplant product called Orca-Q in pediatric and young adult patients with blood cancers (like leukemia or lymphoma), to reduce complications like graft-versus-host disease after bone marrow transplant. **You may be eligible if...** - You are a child or young adult with a blood cancer (leukemia, lymphoma, or similar) - You need a bone marrow (stem cell) transplant - You are being treated at a participating center - A suitable donor is available **You may NOT be eligible if...** - You have severe organ dysfunction - You have an active uncontrolled infection - You have had a prior stem cell transplant (in some protocols) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALOrca-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.


Locations(4)

University of Florida

Gainesville, Florida, United States

University of Miami

Miami, Florida, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

View Full Details on ClinicalTrials.gov

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NCT05322850


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