Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Adults With T-allo10 Cells Addback (NCT04640987)
Phase 1/1b Study of T-allo10 Infusion After HLA-Partially Matched Related or Unrelated TCR Ξ±Ξ²+ T-cell/ CD19+ B-cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation (Ξ±Ξ² Depleted-HSCT) in Children and Young Adults Affected by Hematologic Malignancies
π©Ί Plain-English Summary (8th-Grade Level)
The purpose of this study is to determine the safety of a cell therapy, T-allo10, after Ξ±Ξ²depleted-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 Ξ±Ξ²depleted-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 Ξ±Ξ²depleted-HSCT. Additionally, Phase 1b aims to explore improvements in immune reconstitution. All participants on this study must be enrolled on another study: NCT04249830
Who can join: Review the eligibility criteria below.
Location: Lucile Packard Children's Hospital β Palo Alto, California
Age range: 1 Month to 45 Years
π§ͺ Interventions in This Study
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (1 Sites)
- Lucile Packard Children's Hospital β Palo Alto, California
π Contact the Study Coordinator
Phone: (650) 723-0912
Email: DL-SCTIntakeCoordinators@stanfordchildrens.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- The Use of Residual De-identified Specimens and/or Samples From Patients for Clinical Research β San Diego, California
- The Interplay Between Inborn Error of Immunity and Blood Disorders: Unravelling Immune Defects Behind Common Haematological Diseases β Montreal, Canada
- Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults β Palo Alto, California
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π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.