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
Porteus, Matthew, MD
22 participants
Feb 10, 2021
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria12
- \. 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.
- Patient already received αβdepleted-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 Criteria4
- 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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Interventions
The allogeneic stem cell transplant involves transferring the stem cells from a healthy person (donor) to the participant via infusion.
Device used for production of T-allo10 cells.
T-allo10 cells are made by manipulating the participant's stem cell donor's white blood cells (CD4+ T cells) in the presence of their (participant's) CD14+ monocytes.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04640987