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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Porteus, Matthew, MD
Study ID
NCT04640987
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hematologic Diseases

Eligibility Criteria

Sex
ALL
Age
1 Month - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic Stem Cell Transplant — BIOLOGICAL
    The allogeneic stem cell transplant involves transferring the stem cells from a healthy person (donor) to the participant via infusion.
  • CliniMACS Prodigy System — DEVICE
    Device used for production of T-allo10 cells.
  • T-allo10 cells addback — 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.

Study Details

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

Key Dates

Start date
Feb 10, 2021
Status verified
Jan 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2029

Study Design

Enrollment
22 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lucile Packard Children's HospitalPalo AltoCalifornia94305
Stem Cell and Gene Therapy Clinical Trials Program
[email protected]
650-723-0912
Rosa Bacchetta, MD (SUB_INVESTIGATOR)
David Shyr, MD (SUB_INVESTIGATOR)
Rajni Agarwal, MD (SUB_INVESTIGATOR)

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By research site
Lucile Packard Children's Hospital· Palo Alto, CA

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