Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Adults With T-allo10 Cells Addback

NCT ID: NCT04640987

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-10
• Study Completion Date: 2029-03-31

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Allogeneic Stem Cell Transplant

Intervention Type: BIOLOGICAL

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

CliniMACS Prodigy System

Intervention Type: DEVICE

Device used for production of T-allo10 cells.

T-allo10 cells addback

Intervention Type: DRUG

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.

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

Group Type: EXPERIMENTAL

Allogeneic Stem Cell Transplant

Intervention Type: BIOLOGICAL

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

CliniMACS Prodigy System

Intervention Type: DEVICE

Device used for production of T-allo10 cells.

T-allo10 cells addback

Intervention Type: DRUG

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.

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

Group Type: EXPERIMENTAL

Allogeneic Stem Cell Transplant

Intervention Type: BIOLOGICAL

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

CliniMACS Prodigy System

Intervention Type: DEVICE

Device used for production of T-allo10 cells.

T-allo10 cells addback

Intervention Type: DRUG

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.

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.

Intervention Type: BIOLOGICAL

CliniMACS Prodigy System

Device used for production of T-allo10 cells.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

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

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

California Institute for Regenerative Medicine (CIRM)

OTHER

Sponsor Role: collaborator

Porteus, Matthew, MD

OTHER

Sponsor Role: lead

Responsible Party

Alice Bertaina

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alice Bertaina, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Pediatrics, Stem Cell Transplantation

Locations

Lucile Packard Children's Hospital

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Stem Cell and Gene Therapy Clinical Trials Program

Role: primary

DL-SCTIntakeCoordinators@stanfordchildrens.org

650-723-0912

Other Identifiers

BMT 367 - T-allo10 Alpha Beta

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-58549

Identifier Type: -

Identifier Source: org_study_id