Trial Search Results

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

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Roncarolo, Maria Grazia, MD

Collaborator: California Institute for Regenerative Medicine (CIRM)

Intervention(s):

  • Biological: Allogeneic Stem Cell Transplant
  • Device: CliniMACS Prodigy System
  • Drug: T-allo10 cells addback

Phase:

Phase 1

Eligibility


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
   04249830

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

      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
   NCT04249830.

Ages Eligible for Study

1 Month - 45 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting