NCT04640987RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 8 Jan 2026

Brief summary (registry, in English)

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

Status (registry): Recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 22 (estimated)
First submitted: 17 Nov 2020
Start date: 10 Feb 2021
Primary completion date: 31 Mar 2027
Lead sponsor: Porteus, Matthew, MD
Diseases: Childhood cancers
NCT number: NCT04640987

What you commit to

Study type: Interventional · Phase 1
Planned participants: 22
From 10 Feb 2021 to the primary completion date, 31 Mar 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Received another investigational agent within 30 days of enrollment.
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.

Lab values

Pregnancy (positive serum or urine beta-HCG) within 7 days of MNC donation.

Other

Not eligible to receive HSCT on NCT04249830

Who the study is looking for

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:
- 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.
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.
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.

Age in the registry: 1 month to 45 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Lucile Packard Children's Hospital Coordinator of this site? Confirm its status	Palo Alto	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.