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

First listed
Nov 23, 2020
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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