Safety Study of Gene Modified Donor T Cell Infusion After Stem Cell Transplant for Non-Malignant ā¦ (NCT02231710) | Clinical Trial Compass
TerminatedPhase 1
Safety Study of Gene Modified Donor T Cell Infusion After Stem Cell Transplant for Non-Malignant Diseases
Stopped: due to lack of enrollment and changes to the sponsor development portfolio
United States1 participantsStarted 2015-02
Plain-language summary
The purpose of this study is to determine a safe dose of BPX-501 gene modified T cells infused after a haplo-identical stem cell transplant to facilitate engraftment and the safety of Rimiducid (AP1903) on day 7 to prevent GVHD.
Who can participate
Age range4 Months ā 55 Years
SexALL
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Inclusion criteria
ā. Patient must meet eligibility criteria for allogeneic transplantation
ā. Lack of suitable conventional donor (10/10 allele matched related or unrelated donor) or presence of rapidly progressive disease not permitting time to identify an unrelated donor
ā. Males or females
ā. Age \< 55 years old and \> 4 months
ā. Diagnosis of a nonmalignant disorder considered treatable by HCT.
ā. HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, DRBl, and DQB1 loci.
ā. If capable of reproduction, patient must agree to use contraception or abstinence to prevent pregnancy during the first year of enrollment and treatment.
ā. Informed consent signed by patient (if ā„18 years old) or parent/guardian (if \<18 years old).