WALTHAM, Mass., July 29, 2026
TScan Therapeutics announced that the first patient has been dosed with TSC-101 in the pivotal Phase 3 ALLOHA-2™ clinical trial, marking a major milestone in the development of its investigational T cell receptor-engineered T cell (TCR-T) therapy for patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The patient, enrolled in June, received the first infusion of TSC-101 following successful allogeneic hematopoietic cell transplantation (allo-HCT) and stem cell engraftment. The multicenter study is actively enrolling participants across the United States and is designed to evaluate whether TSC-101 can reduce disease relapse and improve long-term survival in patients with residual disease after transplantation. Topline results are anticipated in mid-2028, positioning the study as a pivotal step toward potential regulatory approval if successful.
Phase 3 Trial Builds on Encouraging Early Clinical Results
The ALLOHA-2™ Phase 3 trial compares standard-of-care allogeneic stem cell transplantation alone with transplantation followed by two infusions of TSC-101 in eligible patients. Enrollment is based on genetic assignment, with patients who are HLA-A*02:01 positive and have an appropriate donor receiving the investigational treatment, while others serve as the control group. The primary endpoint is relapse-free survival, with important secondary endpoints including overall survival and event-free survival. According to TScan Therapeutics, the Phase 3 study is supported by encouraging Phase 1 ALLOHA™ clinical data, where patients treated with the company’s commercial-ready manufacturing process demonstrated a strong safety profile together with promising clinical efficacy. These findings have strengthened confidence in advancing TSC-101 into registrational development for patients facing a high risk of relapse following stem cell transplantation.
TSC-101 Aims to Prevent Relapse After Stem Cell Transplantation
TSC-101 represents an innovative TCR-engineered T cell therapy designed to eliminate residual leukemia cells that remain after allogeneic hematopoietic cell transplantation, one of the leading causes of relapse in patients with AML and MDS. While transplantation remains a potentially curative treatment, many patients experience disease recurrence despite successful engraftment. By targeting residual malignant cells after transplant, TSC-101 aims to improve relapse-free survival without compromising patient safety. Company executives noted that the rapid enrollment observed in earlier studies reflects growing interest from the transplant community and reinforces confidence in the therapy’s potential to become a meaningful addition to post-transplant care. If successful, TSC-101 could provide a new therapeutic strategy to improve long-term outcomes for patients with hematologic malignancies who currently have limited options following transplantation.
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TScan Expands Leadership in TCR-Based Cell Therapy Development
The initiation of the Phase 3 ALLOHA-2™ trial highlights TScan Therapeutics’ continued progress in developing next-generation TCR-engineered therapies for cancer. Beyond TSC-101, the company is advancing additional programs focused on hematologic malignancies, exploring in vivo engineering technologies for solid tumors, and leveraging its proprietary target discovery platform to identify therapies for T cell-mediated autoimmune diseases. Company leadership emphasized that reaching this pivotal clinical milestone reflects years of scientific development, manufacturing innovation, and collaboration with investigators and patients. As enrollment continues nationwide, the ALLOHA-2™ trial is expected to generate critical evidence supporting TSC-101’s potential as a first-in-class therapy for preventing relapse after stem cell transplantation, reinforcing TScan Therapeutics’ position as a leader in advancing cell-based immunotherapies for patients with difficult-to-treat cancers..
Source: TScan Therapeutics press release
