TCRαβ/CD19 Depletion of Stem Cell Grafts for Transplant
Megadott ok: No funding available.
Trial details
- Who runs it
- Neena Kapoor, M.D.
- Trial code
- NCT05968170
- Record updated
- 2025. július 14.
- Original description
The CliniMACS® device is FDA-approved only for one indication (CD34+ selection). Additional use of this device outside of this indication requires the use of feasibility studies.Read full original descriptionShow less
A Feasibility Study Using the CliniMACS® Device for T-Cell Receptor (TCR) αβ+CD3+/CD19+ Depleted Hematopoietic Stem Cells for Patients Undergoing Transplant
The CliniMACS® device is FDA-approved only for one indication (CD34+ selection). Additional use of this device outside of this indication requires the use of feasibility studies.
Children, adolescents and young adults with malignant and non-malignant conditions undergoing hematopoietic stem cell transplants will have stem cells selected using alpha-beta+/CD19+ cell depletion. This is a single arm feasibility study using this processing of peripheral stem cells with alternative donor sources (haploidentical, mismatched, matched unrelated) to determine efficacy as seen by engraftment and graft-versus-host disease (GVHD).
Inclusion: Written informed consent (and written assent, if applicable) obtained prior to enrollment; Age < 21; Lansky Play-Performance Scale or Karnofsky Index score ≥ 60%; Adequate organ function (within 4 weeks of initiation of preparative regimen) as evaluated per institutional guidelines. Adequate major organ system function as demonstrated by:; Renal: Creatinine clearance or GFR of ≥ 60mL/min/1.73m2; Hepatic: total bilirubin < 2 mg/dL (unless due to Gilbert syndrome) and ALT/AST ≤ 2.5 times the upper limit of normal; Cardiac: LVEF at rest ≥ 50% or SF ≥ 27% (by MUGA or ECHO); Pulmonary: DLCO, FEV1, and FVC ≥ 50% of predicted corrected for hemoglobin. For patients < 7 years of age or those unable to perform PFTs: O2 Sat ˃ 92% on room air by pulse oximetry and on no supplemental O2 at rest; Available donor (matched/mismatched unrelated, mismatched related, related haploidentical) who is healthy and willing to donate peripheral blood stem cells; Patients that have been diagnosed with graft rejection/failure or relapse may be eligible to receive a second transplant pending patient status.
Exclusion: Recipient with HLA antibody against donor; Patients with HIV or uncontrolled fungal, bacterial, or viral infections; Patients with active CNS leukemia or any other active site of extramedullary disease at the time of enrollment; Any condition that, in the opinion of the Sponsor-Investigator, would compromise the safety of the participant, prevent study participation, or interfere with the evaluation of study endpoints; Patients that are pregnant, breastfeeding or unwilling to practice birth control during participation of the study.