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

RecruitingPhase 1Ages 1 Month - 45 YearsAllPorteus, Matthew, MD
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In plain words

What the trial is, and whether it could suit you

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 1a 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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Allogeneic Stem Cell Transplant
  • CliniMACS Prodigy System
  • T-allo10 cells addback
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Where

1 site
Lucile Packard Children's Hospital
Palo Alto, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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