TCRαβ/CD19 Depletion of Stem Cell Grafts for 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).

Sex

All

Maximum age

21 Years

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.

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