Cell-Depleted Donor Grafts for Blood Cancers

Overseen By Melinda Triplet, RN

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Nationwide Children's Hospital

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4-6 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase I/II study designed to evaluate the kinetics of hematopoietic reconstitution and the incidence of acute chronic GVHD after partially matched related donor hematopoietic cell transplantation using an αβTCR/CD19+ cell depleted graft.

Eligibility Criteria

This trial is for children and young adults up to 30 years old with certain blood cancers or preleukemia conditions. They must have suitable organ function, may be eligible for a second transplant if needed, and cannot have active untreated infections. Participants need effective contraception if of childbearing potential and lack an HLA matched sibling donor.

Inclusion Criteria

I am using or willing to use effective birth control if I can have children.

I do not have a sibling donor that matches my HLA type.

My organ functions meet specific health standards.

Exclusion Criteria

I have specific antibodies against donor tissues.

Patient reports a history of allergic reactions to murine protein

I do not have a suitable donor available for my treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo haploidentical hematopoietic cell transplantation using an αβTCR/CD19+ cell depleted graft

4-6 weeks

Multiple visits for transplantation and monitoring

Follow-up

Participants are monitored for safety, immune reconstitution, and incidence of GVHD

4 years

Regular follow-up visits over 4 years

Treatment Details

Interventions

• CliniMACS® TCRαβ/CD19 Combined Depletion System
• Partially Matched Related Donor Hematopoietic Cell Transplantation
• αβTCR/CD19+ Cell Depleted Graft

Trial Overview The study tests the CliniMACS® TCRαβ/CD19 Depletion System in partially matched related donor hematopoietic cell transplantation. It aims to observe how quickly patients recover their blood cells and the occurrence of graft-versus-host disease after the procedure.

Participant Groups

Group I: CliniMACS Isolation Experimental Treatment 1 Intervention

The mobilized peripheral blood cell collection (apheresis product) will be processed using a Miltenyi CliniMACS device according to the manufacturing instructions. The processing will deplete the αβTCR+ cells and CD19+ cells from the apheresis product to formulate the graft.

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+