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Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Adults With T-allo10 Cells Addback
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
Who can join
1 Month – 45 Years · All sexes
Full eligibility criteria
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.
About the study
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
What is being tested
- Allogeneic Stem Cell Transplant (biological)
- CliniMACS Prodigy System (device)
- T-allo10 cells addback (drug)
Sponsor: Porteus, Matthew, MD · Participants: 22 · Started: Feb 10, 2021
Contact the study team
Official record on ClinicalTrials.gov — NCT04640987
Locations in the U.S.
| California | Lucile Packard Children's Hospital, Palo Alto |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.