Stem cell transplant with T-allo10 cell therapy for hematologic diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of T-allo10 cell therapy following alpha beta cell depletion in hematopoietic stem cell transplantation (HSCT) for children and young adults with life-threatening hematologic malignancies. The study is divided into two phases: Phase 1a focuses on determining the recommended dose of T-allo10 cells, while Phase 1b will assess the safety and effectiveness of this therapy at the established dose. The goal is to enhance immune reconstitution while minimizing the risk of severe Graft-versus-Host Disease (GvHD). Participants must also be enrolled in a related study, NCT04249830.

Why it matters

Who can join: the full rules

Inclusion Criteria prior to enrollment:

* 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.

Inclusion criteria prior to T-allo10 infusion:

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 prior to MNC collection for Tallo-10 manufacturing.:

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.

Where it's running

• Lucile Packard Children's Hospital
  Palo Alto, California, United States Recruiting

Study contacts

• Principal investigator: Alice Bertaina, MD, PhD — Professor of Pediatrics, Stem Cell Transplantation

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.