A Controlled Multi-Arm Phase 1 Umbrella Study Evaluating the Safety and Feasibility of T-Cell Receptor Engineered Donor T-Cells Targeting HA-1 (TSC-100) or HA-2 (TSC-101) in HLA-A*02:01 Positive Patients Undergoing Haploidentical Allogeneic Peripheral


NCT Number:



Study Status:






The study involves research of two study drugs (TSC 100 and TSC 101), given in combination with the standard of care (SOC). The purpose of the study is to see if TSC 100 and TSC 101 are safe and effective in treating your blood cancer. The study also is measuring the effect of these study drugs on your immune system (immunogenicity of study drugs). TSC 100 and TSC-101 are experimental new study drugs that have not yet been approved by the US Food and Drug Administration (FDA) or regulatory authorities in any other countries. This is a first-in-human study, which means that these study drugs have never been administered to humans before. TSC 100 and TSC 101 are new biological therapeutics (substances that help the immune system fight cancer), being developed by the Sponsor, consisting of transplanted healthy blood forming cells (HCT) donor-derived T cell products, called “TCR-T therapy”. T cells are part of the immune system and develop from stem cells in the bone marrow. They help protect the body from infection and fight cancer. For this study, T-cells will be collected through leukapheresis from your study donor and will be used to make TSC 100 or TSC 101 specifically tailored for you and your immune system. Leukapheresis is the removal of the blood to collect specific blood cells, and the remaining blood is returned to the body.

Are you Eligible? (Inclusion Criteria)

  • At least 18 years old
  • Preparing to undergo allogeneic HCT for AML, MDS, or ALL
  • Have a haploidentical related adult donor for HCT who is adequately HLA-matched
  • Participants must agree to participate in long-term follow-up for up to 15 years post initial product treatment if they are enrolled in the study and receive the investigational T-cell infusion

Specialty Area(s)

Blood and Marrow Stem Cell Transplantation, Leukemia, Acute Lymphocytic leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Immunotherapy

Principal Investigator

Profile Headshot
  • Director of Translational Research, Blood and Marrow Transplantation Program
  • Director of the Cell Therapy Program

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032