Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT

The major morbidities of allogeneic hematopoietic stem cell transplant (HSCT) using donors that are not human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life- threatening infections. T cell receptor alpha beta (TCRαβ) T lymphocyte depletion and CD19+ B lymphocyte depletion of alternative donor hematopoietic stem cell (HSC) grafts is effective in preventing GVHD, but immune reconstitution may be delayed, increasing the risk of infections. The central hypothesis of this study is that an addback of CD45RO memory T lymphocytes, derived from a fraction of the orig

Trial Details

NCT ID
NCT06839456
Phase
PHASE1 / PHASE2
Sponsor
Children's Hospital of Philadelphia
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • Phase 1 Dose Level 1
  • Phase 1 Dose Level 2
  • Phase 1 Dose Level 3
  • Phase 2 Maximum Tolerated Dose determined in Phase 1
  • Phase 2 Established Dose from prior study, NCT03810196
Locations (sample)
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362

Key Eligibility Criteria

  • Disease for which allogeneic HSCT may be curative.
  • Remission status of hematologic malignancies and additional disease-specific eligibility determinations will be according to standards of practice …
  • Patients must be 25 years of age and less
  • Evaluation for organ and infectious status as per our CTTS standard operating procedure.

For full eligibility, visit ClinicalTrials.gov.

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