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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2027
  • participants needed
    22
  • sponsor
    Stanford University
Updated on 26 July 2021
cell transplantation
leukemia

Summary

The purpose of this study is to determine the safety of a cell therapy, T-allo10, after depleted-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 depleted-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 depleted-HSCT. Additionally, Phase 1b aims to explore improvements in immune reconstitution.

All participants on this study must be enrolled on another study: NCT04249830

Details
Condition Blood disorder, hematologic disorder, blood disorders, hematologic disorders, hematologic disease, blood diseases, hematological disease, blood dyscrasias, blood dyscrasia, haematological disorders
Treatment Allogeneic stem cell transplant, CliniMACS Prodigy System, T-allo10 cells addback
Clinical Study IdentifierNCT04640987
SponsorStanford University
Last Modified on26 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\. Age > 1 months (with minimum weight of 10 Kg) and < 45 years
\. Patients deemed eligible for allogeneic HSCT under the originating study, NCT 04249830
\. Patients with life-threatening hematological malignancies for which HSCT has been
recommended
High-risk ALL in 1st CR, ALL in 2nd or subsequent CR
High-risk AML in 1st CR, AML in 2nd or subsequent CR
Myelodysplastic syndrome
JMML (Juvenile myelomonocytic leukemia)
Non-Hodgkin lymphomas in 2nd or subsequent CR
Other hematologic malignancies eligible for stem cell transplantation per institutional standard
\. 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
Patient already received depleted-HSCT and has myeloid engraftment
Absence of active grade II aGvHD requiring >0.5 mg/Kg of steroids or any diagnosis of grade III/IVaGvHD

Exclusion Criteria

Not eligible to receive HSCT on NCT04249830
Received another investigational agent within 30 days of enrollment
Pregnancy (positive serum or urine beta-HCG) within 7 days of MNC donation
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
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