Phase 12 Study of CD45RA Depleted Stem Cell Addback to Reduce Viral and Fungal Infections After Alternative Donor TCRabCD19 Depleted Hematopoietic Stem Cell Transplant in Patients Up to 25 Years

What this Trial Is About

Researchers are evaluating a new approach to prevent serious viral and fungal infections after allogeneic hematopoietic stem cell transplant HSCT from donors who are not fully HLA-matched siblings. This study focuses on adding back CD45RO memory T cells to grafts depleted of T cell receptor alpha beta TCRb1b2 and CD19 B cells to reduce the risk of graft versus host disease GVHD while improving immune recovery. The trial expands eligibility to patients with both malignant and non-malignant conditions using mismatched related and unrelated donors. The study includes phase 1 and phase 2 periods. Phase 1 is a dose escalation study for patients receiving cells from mismatched or haploidentical related donors, testing increasing doses of CD45RA-depleted addback cells to find the maximum tolerated dose. Phase 2 treats patients with this dose from phase 1 or those with unrelated donors using a previously established dose. Stem cell sources are mobilized peripheral blood stem cells, and conditioning follows disease-specific standard care. Participants will be monitored for acute and chronic GVHD up to 2 years after transplant. Their immune recovery and incidence of viral reactivation will also be evaluated over 2 years. Assessments include standard disease and organ criteria, infection status, and consent procedures. The trial duration and safety are closely observed with regular follow-ups to measure outcomes related to immune function and transplant complications.

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