Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Adults With T-allo10 Cells Addback
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|ClinicalTrials.gov Identifier: NCT04640987|
Recruitment Status : Not yet recruiting
First Posted : November 23, 2020
Last Update Posted : November 23, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Diseases||Biological: Allogeneic Stem Cell Transplant Device: CliniMACS Prodigy System Drug: T-allo10 cells addback||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||December 2020|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2027|
Experimental: Experimental: Stem Cell Transplant
The participant will undergo a stem cell transplant using donor cells that have been manipulated through an investigational device. The participant's cells will then be manipulated via a T-allo10 cell addback. Participants will be followed for outcomes for two years.
Biological: Allogeneic Stem Cell Transplant
The allogeneic stem cell transplant involves transferring the stem cells from a healthy person (donor) to the participant via infusion.
Device: CliniMACS Prodigy System
Device used for production of T-allo10 cells.
Drug: T-allo10 cells addback
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.
- Number of participants with myeloid engraftment after T-allo10 [ Time Frame: Through day 35 (+/- 7 days) after αβdepleted-HSCT ]
- Number of participants without grade II aGvHD requiring steroids after T-allo10 [ Time Frame: Through day 35 (+/- 7 days) after αβdepleted-HSCT ]
- Number of participants without grade III/IV aGvHD after T-allo10 [ Time Frame: Through day 35 (+/- 7 days) after αβdepleted-HSCT ]
- Number of participants with absence of dose-limiting toxicity (DLT) 28 days following the infusion of T-allo10 given at the recommended phase 2 dose (RP2D) [ Time Frame: Assessed at 28 days (after infusion of T-allo10) ]
- Number of participants who reach immune reconstitution (IR) threshold [ Time Frame: Through Day 60 (+/- 10 days) after infusion of T-allo10 ]IR (a surrogate of reduced risk of leukemia recurrence) is defined reaching the threshold of 50CD3+CD4+T-cells/µl by Day+60(+/-10days).
- Number of participants with ≥grade 3 adverse event related to T-allo10 infusion [ Time Frame: Through 1 year after αβdepleted-HSCT ]
- Number of participants with grade II-IV aGvHD [ Time Frame: Assessed at day 90 after αβdepleted-HSCT ]
- Number of participants with grade III-IV aGvHD [ Time Frame: Assessed at day 180 after αβdepleted-HSCT ]
- Number of participants with cGvHD [ Time Frame: Assessed at 1 year after αβdepleted-HSCT ]
- Leukemia-free survival [ Time Frame: Assessed at 1 year after αβdepleted-HSCT ]Leukemia-free survival defined as at the time of enrollment to disease relapse or death from any cause.
- Number of participants with disease relapse [ Time Frame: Assessed at 1 year after αβdepleted-HSCT ]Disease relapse is defined as the return of signs and symptoms of a disease after a remission.
- Non-relapse mortality [ Time Frame: Assessed at Day 90 after αβdepleted-HSCT ]
- Non-relapse mortality [ Time Frame: Assessed at 1 year after αβdepleted-HSCT ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04640987
|United States, California|
|Lucile Packard Children's Hospital|
|Palo Alto, California, United States, 94305|
|Principal Investigator:||Alice Bertaina, MD, PhD||Associate Professor of Pediatrics, Stem Cell Transplantation|