NCT04640987

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

Recruiting now Phase 1 Last updated 6 January 2026

What this trial tests

Phase 1 trial testing Allogeneic Stem Cell Transplant in Hematologic Diseases in 22 participants. Currently enrolling.

Timeline

10 February 2021

Primary endpoint
1 March 2027

1 March 2029

Quick facts

Lead sponsor	Porteus, Matthew, MD
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	10 February 2021
Primary completion	1 March 2027
Estimated completion	1 March 2029
Sites	1 location across United States

Drugs / interventions tested

• Allogeneic Stem Cell Transplant — full drug profile →
• CliniMACS Prodigy System
• T-allo10 cells addback — full drug profile →

Conditions studied

• Hematologic Diseases — all drugs for Hematologic Diseases →

Sponsor

Porteus, Matthew, MD — full company profile →

Who can join

Adults 1 Month to 45, any sex, with Hematologic Diseases. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
  RP2D was determined by testing 3 different escalating doses (1x10\^5, 3x10\^5 and 1x10\^6 cells/Kg recipient body weight) in dose escalation cohorts 1 to 3 with 3 to 6 participants each. RP2D reflects the acceptable dose levels that did not cause a Dose-Limiting Toxicity (DLT) in ≥33% of participants and resulted in success with response in \>83% of participants. DLTs were defined as Grade IV aGvH
• Number of participants with absence of dose-limiting toxicity (DLT)
  Time frame: Assessed at 28 days (after infusion of T-allo10)
  Grade IV aGvHD post T-allo10 infusion; any grade 3 or 4 related treatment emergent adverse events (TEAE); any grade 3 or 4 suspected AE
• Number of participants who reach immune reconstitution (IR) threshold
  Time frame: Up to Day 60 (+/- 10 days) after αβdepleted-HSCT
  IR (a surrogate of reduced risk of leukemia recurrence) is defined reaching the threshold of 50CD3+CD4+T-cells/µl by Day+60 (+/-10days).

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Yin and Yang of Type 1 Regulatory T Cells: From Discovery to Clinical Application.
   Sayitoglu EC, Freeborn RA, Roncarolo MG. · · 2021 · cited 23× · PMID 34177953 · DOI 10.3389/fimmu.2021.693105
2. From promise to practice: CAR T and Treg cell therapies in autoimmunity and other immune-mediated diseases.
   Bulliard Y, Freeborn R, Uyeda MJ, Humes D, et al · · 2024 · cited 19× · PMID 39697333 · DOI 10.3389/fimmu.2024.1509956
3. Regulatory T cell therapies: biological foundations, engineering strategies, and clinical translation.
   Plaisse C, Bézie S, Guillonneau C. · · 2026 · PMID 42079605 · DOI 10.3389/fimmu.2026.1797186
4. Regulatory T cell approaches for graft-versus-host disease prevention.
   Bader CS, Meyer EH, Negrin RS. · · 2026 · PMID 41172558 · DOI 10.1016/j.coi.2025.102685