Treatment Use of the CliniMACS® CD34 TCR Alpha/Beta for Allogenic Transplant (Expanded Access Use)
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
AgeUp to 21
SponsorVictor Aquino
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CliniMACS® CD34 TCR Alpha/Beta
Treatment groups
No treatment groups listed
Sponsors and collaborators
Victor Aquino
Lead sponsor
University of Texas Southwestern Medical Center
Sponsor institution
Source ClinicalTrials.gov