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

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:

• High-risk ALL in 1st CR, ALL in 2nd or subsequent CR;
• High-risk AML in 1st CR, AML in 2nd or subsequent CR;
• Myelodysplastic syndrome;
• JMML (Juvenile myelomonocytic leukemia);
• Non-Hodgkin lymphomas in 2nd or subsequent CR;
• 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:

• Patient already received αβdepleted-HSCT and has myeloid engraftment.
• 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.:

• Not eligible to receive HSCT on NCT04249830
• Received another investigational agent within 30 days of enrollment.
• Pregnancy (positive serum or urine beta-HCG) within 7 days of MNC donation.
• 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.