Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Adults With T-allo10 Cells Addback
- Conditions
- Hematologic Diseases
- Interventions
- Device: CliniMACS Prodigy SystemDrug: T-allo10 cells addback
- Registration Number
- NCT04640987
- Lead Sponsor
- Porteus, Matthew, MD
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 Allogeneic Stem Cell Transplant The participant will undergo a alpha-beta depleted stem cell transplant using donor cells. The participant's cells will then be manipulated via a T-allo10 cell addback to reach a dose level of 1 X 10\^5/kg Cohort 1 CliniMACS Prodigy System The participant will undergo a alpha-beta depleted stem cell transplant using donor cells. The participant's cells will then be manipulated via a T-allo10 cell addback to reach a dose level of 1 X 10\^5/kg Cohort 1 T-allo10 cells addback The participant will undergo a alpha-beta depleted stem cell transplant using donor cells. The participant's cells will then be manipulated via a T-allo10 cell addback to reach a dose level of 1 X 10\^5/kg Cohort 2 Allogeneic Stem Cell Transplant The participant will undergo a alpha-beta depleted stem cell transplant using donor cells. The participant's cells will then be manipulated via a T-allo10 cell addback to reach a dose level of 3 X 10\^5/kg Cohort 2 CliniMACS Prodigy System The participant will undergo a alpha-beta depleted stem cell transplant using donor cells. The participant's cells will then be manipulated via a T-allo10 cell addback to reach a dose level of 3 X 10\^5/kg Cohort 2 T-allo10 cells addback The participant will undergo a alpha-beta depleted stem cell transplant using donor cells. The participant's cells will then be manipulated via a T-allo10 cell addback to reach a dose level of 3 X 10\^5/kg Cohort 3 Allogeneic Stem Cell Transplant The participant will undergo a alpha-beta depleted stem cell transplant using donor cells. The participant's cells will then be manipulated via a T-allo10 cell addback to reach a dose level of 1 X 10\^6/kg Cohort 3 CliniMACS Prodigy System The participant will undergo a alpha-beta depleted stem cell transplant using donor cells. The participant's cells will then be manipulated via a T-allo10 cell addback to reach a dose level of 1 X 10\^6/kg Cohort 3 T-allo10 cells addback The participant will undergo a alpha-beta depleted stem cell transplant using donor cells. The participant's cells will then be manipulated via a T-allo10 cell addback to reach a dose level of 1 X 10\^6/kg
- Primary Outcome Measures
Name Time Method Number of participants with myeloid engraftment after T-allo10 Through day 35 (+/- 7 days) after αβdepleted-HSCT Number of participants without grade II aGvHD requiring steroids after T-allo10 Through day 35 (+/- 7 days) after αβdepleted-HSCT Number of participants without grade III/IV aGvHD after T-allo10 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) Assessed at 28 days (after infusion of T-allo10) Number of participants who reach immune reconstitution (IR) threshold 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).
- Secondary Outcome Measures
Name Time Method Number of participants with ≥grade 3 adverse event related to T-allo10 infusion Through 1 year after αβdepleted-HSCT Number of participants with grade II-IV aGvHD Assessed at day 90 and day 180 after αβdepleted-HSCT Cumulative incidence of acute GvHD (graded as II-IV using the Magic criteria)
Number of participants with grade III-IV aGvHD Assessed at day 90 and day 180 after αβdepleted-HSCT Cumulative incidence of acute GvHD (graded as III-IV using the Magic criteria)
Number of participants with cGvHD Assessed at 1 year after αβdepleted-HSCT Number of participants who achieved leukemia-free survival 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 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 Assessed at 1 year after αβdepleted-HSCT
Trial Locations
- Locations (1)
Lucile Packard Children's Hospital
🇺🇸Palo Alto, California, United States