Treatment Use of the CliniMACS® CD34 TCR Alpha/Beta for Allogenic Transplant (Expanded Access Use)

NCT06393660 | Unknown

• 1 other identifier: STU-2024-0185
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The protocol is designed to provide access to patients to the Clinimacs® CD34 TCRαβ system to prepare cells for an unlabeled indication using an HLA-compatible related or unrelated donor for allogenic transplant.

Conditions

Transplant-Related Disorder; GVH - Graft Versus Host Reaction

Keywords

TCR Alpha/Beta; CliniMACS

Interventions

CliniMACS® CD34 TCR Alpha/Beta DEVICE

CliniMACS System uses an automated antibody/magnetic beads column system that allows efficient depletion of TCRαβ and CD19+ cells without relevant loss of cell viability. Hematopoietic stem cells are retained in sufficient numbers to permit engraftment and hematopoietic reconstitution. Humanitarian Exemption IDE approval has been obtained for CD34+ cell selection as a method of T-cell depletion.

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age less than 22 years of age
• No available genotypically matched related donor (sibling)
• Availability of a suitable donor and graft source
• Haploidentical related mobilized peripheral blood cells
• /10 or 10/10 allele matched (HLA-A, -B, -C, -DRB1, -DQB1) volunteer unrelated donor mobilized peripheral blood cells
• Matching as described in the Recipient and Donor Suitability Criteria
• Size and vascular access appropriate by center standard for peripheral blood stem cell (PBSC) collection. Donors with inadequate peripheral access will require placement of an apheresis catheter for collection.
• Must meet appropriate screening/eligibility requirements:
• Haploidentical matched family members: screened by center health screens and found to be eligible.
• Unrelated donors: meet suitability criteria to donate PBSC
• HIV negative
• Not pregnant or lactating
• Recipient must not have high-level donor specific anti-HLA antibodies according to institutional practices.
• Must agree to donate PBSC
• Must give informed consent

You may not qualify if:

• Pregnant or lactating females are ineligible as the risk to unborn children and infants is unknown
• Presence of life-threatening, uncontrolled opportunistic infection (fungal, bacterial, or viral infections). Patients with history of fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no or minimal evidence of disease remaining by CT evaluation.
• HIV or HTLV I/II infection

Sponsors & Collaborators

• Victor Aquino: lead

Study Sites (1)

Children's Medical Center - Dallas

Dallas, Texas, 75235, United States

AVAILABLE

Central Study Contacts

Victor Aquino, MD

CONTACT

214-648-3896; Victor.Aquino@utsouthwestern.edu

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: May 1, 2024
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)