Recruiting
Phase 1

Stem Cell Transplant

Sponsor:

Porteus, Matthew, MD

Code:

NCT04640987

Conditions

Hematologic Diseases

Eligibility Criteria

Sex: All

Age: 0 - 45

Healthy Volunteers: Not accepted

Interventions

Allogeneic Stem Cell Transplant

CliniMACS Prodigy System

T-allo10 cells addback

Study Details

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

Conditions

Hematologic Diseases

Study ID

NCT04640987

Start date

Feb 10, 2021

Status verified date

Jan, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria prior to enrollment:

  • 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:

1. High-risk ALL in 1st CR, ALL in 2nd or subsequent CR;
2. High-risk AML in 1st CR, AML in 2nd or subsequent CR;
3. Myelodysplastic syndrome;
4. JMML (Juvenile myelomonocytic leukemia);
5. Non-Hodgkin lymphomas in 2nd or subsequent CR;
6. 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.

Inclusion criteria prior to T-allo10 infusion:

1. Patient already received αβdepleted-HSCT and has myeloid engraftment.
2. Absence of active grade II aGvHD requiring >0.5 mg/Kg of steroids or any diagnosis of grade III/IVaGvHD.

Exclusion Criteria prior to MNC collection for Tallo-10 manufacturing.:

1. Not eligible to receive HSCT on NCT04249830
2. Received another investigational agent within 30 days of enrollment.
3. Pregnancy (positive serum or urine beta-HCG) within 7 days of MNC donation.
4. 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.

Study Design

Enrollment

22 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

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

experimental: Cohort 2

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

experimental: Cohort 3

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

Interventions

Allogeneic Stem Cell Transplant

The allogeneic stem cell transplant involves transferring the stem cells from a healthy person (donor) to the participant via infusion.

CliniMACS Prodigy System

Device used for production of T-allo10 cells.

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.

Primary outcome measure

  • Recommended Phase 2 Dose (RP2D) of T-allo10 in Phase 1a [ Time Frame: Up to 28 days after infusion of T-allo10 for each dosing cohort and Day +60 (+/- 10 days) after αβdepleted-HSCT ]
  • Number of participants with absence of dose-limiting toxicity (DLT) [ Time Frame: Assessed at 28 days (after infusion of T-allo10) ]
  • Number of participants who reach immune reconstitution (IR) threshold [ Time Frame: Up to Day 60 (+/- 10 days) after αβdepleted-HSCT ]

Central Contacts and Locations

Locations

Lucile Packard Children's Hospital

Recruiting

Palo Alto, California, United States, 94305

Contacts

Stem Cell and Gene Therapy Clinical Trials Program

650-723-0912DL-SCTIntakeCoordinators@stanfordchildrens.org

More Information

Sponsor

Porteus, Matthew, MD

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Porteus, Matthew, MD on 2026-01-08.