TCRαβ/CD19 Depletion of Stem Cell Grafts for Transplant

Launched by NEENA KAPOOR, M.D. · Jul 20, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new method to improve stem cell transplants for children, teenagers, and young adults with certain types of blood cancers and other serious conditions. The study focuses on using a special device called the CliniMACS® to select specific stem cells from donors, which may help reduce complications like graft-versus-host disease (GVHD), a condition where the donated cells attack the recipient’s body. The researchers want to see if this new approach can help the body accept the transplanted cells better.

To participate in the trial, candidates must be under 21 years old, have good overall health as shown by specific tests, and have a willing and healthy donor who can provide stem cells. Patients with certain infections or active diseases, as well as those who are pregnant or breastfeeding, cannot join the study. If eligible, participants will undergo the stem cell transplant and be monitored closely to see how well the new method works. It's important to note that this trial is not yet recruiting participants, but it aims to provide valuable information for future treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.
• • Recipient with HLA antibody against donor.
• • Patients that are pregnant, breastfeeding or unwilling to practice birth control during participation of the study.
• • 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.