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 Blood Stem Cell Transplantation
Study of TSC 100 & TSC 101 in Patients with Leukemia Undergoing Haploidentical Allogeneic Blood Stem Cell Transplantation (HCT)
Sponsor: TScan Therapeutics, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAU1152
U.S. Govt. ID: NCT05473910
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: 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.
Ran Reshef, MD
Do You Qualify?
Are you at least 18 years old? Yes No
Are you preparing to undergo allogeneic HCT? Yes No
You may be eligible for this study

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