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

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

This study is testing a new cell therapy called T-allo10 to see if it can help children and young adults with serious blood cancers after a stem cell transplant while reducing the risk of complications.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 1 Month to 45 Years
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT04640987 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include children and young adults aged 1 month to 45 years with life-threatening hematologic malignancies eligible for HSCT.

Not a fit: Patients with hematologic conditions not eligible for HSCT or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve immune recovery and reduce complications in patients undergoing stem cell transplantation.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in enhancing immune reconstitution post-transplant.

Eligibility criteria

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 this trial is running

Palo Alto, California

• 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

Conditions Hematologic Diseases