Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Adults With T-allo10 Cells Addback


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Trial ID: NCT04640987


The purpose of this study is to determine the safety of a cell therapy, T-allo10, after αβdepleted-HSCT in the hopes that it will boost the adaptive immune reconstitution of the patient while sparing the risk of developing severe Graft-versus-Host Disease (GvHD). The primary objective of Phase 1 is to determine the recommended Phase 2 dose (RP2D) administered after infusion of αβdepleted-HSCT in children and young adults with hematologic malignancies. A Phase 1b extension will occur after dose escalation, enrolling at the RP2D for the T-allo10 cells determined in the Phase 1 portion to evaluate the safety and efficacy of infusion of T-allo10 after receipt of αβdepleted-HSCT. Additionally, Phase 1b aims to explore improvements in immune reconstitution. All participants on this study must be enrolled on another study: NCT04249830

Official Title

Phase 1/1b Study of T-allo10 Infusion After HLA-Partially Matched Related or Unrelated TCR αβ+ T-cell/ CD19+ B-cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation (αβ Depleted-HSCT) in Children and Young Adults Affected by Hematologic Malignancies

Stanford Investigator(s)

Maria Grazia Roncarolo

George D. Smith Professor of Stem Cell and Regenerative Medicine and Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)


Inclusion Criteria prior to enrollment:

   - 1. Age > 1 months (with minimum weight of 10 Kg) and < 45 years.

   - 2. Patients deemed eligible for allogeneic HSCT under the originating study, NCT

   - 3. Patients with life-threatening hematological malignancies for which HSCT has been

      1. High-risk ALL in 1st CR, ALL in 2nd or subsequent CR;

      2. High-risk AML in 1st CR, AML in 2nd or subsequent CR;

      3. Myelodysplastic syndrome;

      4. JMML (Juvenile myelomonocytic leukemia);

      5. Non-Hodgkin lymphomas in 2nd or subsequent CR;

      6. Other hematologic malignancies eligible for stem cell transplantation per
      institutional standard.

   - 4. All subjects ≥ 18 years of age must be able to give informed consent, or adults
   lacking capacity to consent must have a LAR available to provide consent. For subjects
   <18 years old their LAR (i.e. parent or guardian) must give informed consent.
   Pediatric subjects will be included in age appropriate discussion and verbal assent
   will be obtained for those > 7 years of age, when appropriate.

Inclusion criteria prior to T-allo10 infusion:

   1. Patient already received αβdepleted-HSCT and has myeloid engraftment.

   2. Absence of active grade II aGvHD requiring >0.5 mg/Kg of steroids or any diagnosis of
   grade III/IVaGvHD.

Exclusion Criteria prior to MNC collection for Tallo-10 manufacturing.:

   1. Not eligible to receive HSCT on NCT04249830

   2. Received another investigational agent within 30 days of enrollment.

   3. Pregnancy (positive serum or urine beta-HCG) within 7 days of MNC donation.

   4. Patient or donor is not willing or able to undergo an additional non-mobilized
   apheresis for collection of MNC prior to donation of cells for participation in


biological: Allogeneic Stem Cell Transplant

device: CliniMACS Prodigy System

drug: T-allo10 cells addback


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305