Actively Recruiting
Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Adults With T-allo10 Cells Addback
Led by Porteus, Matthew, MD · Updated on 2026-01-08
22
Participants Needed
1
Research Sites
420 weeks
Total Duration
On this page
Sponsors
P
Porteus, Matthew, MD
Lead Sponsor
C
California Institute for Regenerative Medicine (CIRM)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Adults With T-allo10 Cells Addback
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 1 month (minimum weight 10 kg) and less than 45 years
- Eligible for allogeneic HSCT under study NCT04249830
- Diagnosed with life-threatening hematologic malignancies recommended for HSCT, including high-risk ALL or AML in remission, myelodysplastic syndrome, juvenile myelomonocytic leukemia, non-Hodgkin lymphoma in remission, or other eligible blood cancers
- Adults (18 years or older) able to give informed consent or have a legally authorized representative (LAR) to consent
- For children under 18, a parent or guardian must give consent; verbal assent obtained from children over 7 when appropriate
- Patient has already received alpha beta depleted HSCT and shows myeloid engraftment
- No active grade II aGvHD requiring more than 0.5 mg/kg steroids or any grade III/IV aGvHD at time of T-allo10 infusion
You will not qualify if you...
- Not eligible for HSCT under study NCT04249830
- Received another investigational treatment within 30 days before enrollment
- Pregnant within 7 days before mononuclear cell (MNC) donation
- Patient or donor unwilling or unable to undergo an additional non-mobilized apheresis for MNC collection prior to cell donation for participation in study NCT04249830
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94305
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here