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Stem Cell Transplant with T-allo10 for Hematologic Diseases

This study is testing a new cell therapy called T-allo10, given after an allogeneic stem cell transplant (a transplant using stem cells from a healthy donor). The goal is to see if T-allo10 can help your immune system recover better after the transplant, while also reducing the risk of a serious complication called Graft-versus-Host Disease (GvHD). Researchers want to find the safest and most effective dose of T-allo10. This study is for children and young adults, aged 1 month to 45 years, who have life-threatening blood cancers and are eligible for a stem cell transplant. The study is currently unclear on its recruitment status and plans to enroll 22 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to determine the recommended dose of T-allo10 and assess its safety and effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and immune recovery will be assessed up to 60 days after the stem cell transplant.

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NCT04640987

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

Recruiting
PHASE1Ages 1–45InterventionalTreatment
Porteus, Matthew, MD
~22 participants
Updated 2026-01-08 on ClinicalTrials.gov
What's tested:Allogeneic Stem Cell TransplantCliniMACS Prodigy SystemT-allo10 cells addback

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended Phase 2 Dose (RP2D) of T-allo10 in Phase 1a
Measured over Up to 28 days after infusion of T-allo10 for each dosing cohort and Day +60 (+/- 10 days) after αβdepleted-HSCT
+2 more outcomes measured

Conditions

Hematologic Diseases

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Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaHematologic NeoplasmJuvenile Myelomonocytic LeukemiaMyelodysplastic SyndromeNon-Hodgkin Lymphoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Alice Bertaina, MD, PhD · PRINCIPAL_INVESTIGATOR · Professor of Pediatrics, Stem Cell Transplantation

Who to contact

Stem Cell and Gene Therapy Clinical Trials Program
[email protected]
650-723-0912
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Eligibility criteria

Inclusion

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:
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.

What this trial measures

  • Recommended Phase 2 Dose (RP2D) of T-allo10 in Phase 1aUp 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 aGvHD post T-allo10 infusion; any grade 3 or 4 related TEAE; any grade 3 or 4 suspected AE. Success with response was defined as achieving CD4+ IR by Day +60 (+/- 10 days) after αβdepleted-HSCT.

  • Number of participants with absence of dose-limiting toxicity (DLT)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) thresholdUp 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).