Advancing Regenerative Medicine
Stanford's Alpha Clinic supports the advancement of regenerative therapies in the following ways
Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Adults With T-allo10 Cells Addback
The purpose of this study is to determine the safety of a cell therapy, T-allo10, after αβdepleted-HSCT in the hopes that it will boost the adaptive immune reconstitution of the patient while sparing the risk of developing severe Graft-versus-Host Disease (GvHD).
The primary objective of Phase 1a is to determine the recommended Phase 2 dose (RP2D) administered after infusion of αβdepleted-HSCT in children and young adults with hematologic malignancies.
A Phase 1b extension will occur after dose escalation, enrolling at the RP2D for the T-allo10 cells determined in the Phase 1 portion to evaluate the safety and efficacy of infusion of T-allo10 after receipt of αβdepleted-HSCT. Additionally, Phase 1b aims to explore improvements in immune reconstitution.
All participants on this study must be enrolled on another study: NCT04249830
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: Allogeneic Stem Cell Transplant
- device: CliniMACS Prodigy System
- drug: T-allo10 cells addback
Eligibility
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.
Ages Eligible for Study
1 Month - 45 Years
Genders Eligible for Study
ALL
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
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The Alpha Clinic Network
We are part of a state-wide network funded by the California Institute for Regenerative Medicine
This network includes: