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

Launched by PORTEUS, MATTHEW, MD · Nov 17, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new cell therapy called T-allo10, which is given to patients after they receive a specific type of stem cell transplant known as αβdepleted-HSCT. The goal of the study is to see if T-allo10 can safely help the immune system recover while reducing the risk of a serious complication called Graft-versus-Host Disease (GvHD). This trial is focused on children and young adults with life-threatening blood cancers, and it aims to find the best dose of T-allo10 to use in future studies.

To participate, individuals must be between 1 month and 45 years old and have been recommended for a stem cell transplant due to specific types of blood cancers. They must also have completed the stem cell transplant and have stable health without severe GvHD. Participants who join this trial will be monitored closely to ensure their safety and to assess how well the treatment works. It's important to note that participants must also be enrolled in another study to be eligible for this trial.

Gender

ALL

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.