TScan Therapeutics Announces First Patient Dosed in Phase 3 ALLOHA-2™, a Pivotal Trial Evaluating TSC-101 in Patients with Heme Malignancies
Rhea-AI Summary
TScan Therapeutics (Nasdaq: TCRX) reported dosing the first patient with TSC-101 in its pivotal Phase 3 ALLOHA-2™ trial (NCT07702578), which is actively enrolling patients across the US and has an anticipated topline data readout in mid-2028.
The study evaluates TSC-101 for treating residual disease to prevent relapse after allogeneic hematopoietic cell transplantation (allo-HCT) in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). According to TScan, initial Phase 1 ALLOHA™ Cohort C data using the commercial-ready process showed strong clinical efficacy and a positive safety profile, supporting progression to Phase 3. ALLOHA-2 compares standard-of-care HCT plus TSC-101 versus HCT alone, using biological assignment based on A*02:01 status and donor availability. All subjects receive reduced-intensity conditioning, and treatment-arm patients get two TSC-101 infusions post-engraftment. The primary endpoint is relapse-free survival, with overall and event-free survival as key secondary endpoints.
Positive
- First patient dosed in Phase 3 ALLOHA-2™, marking pivotal trial initiation for TSC-101 in AML/MDS after allo-HCT
- Topline Phase 3 data expected mid-2028, providing a defined timeline for a key value-inflection readout
- Phase 1 Cohort C showed strong clinical efficacy and positive safety using commercial-ready manufacturing, according to TScan
- Biology-based assignment design compares TSC-101 plus HCT versus HCT alone under standard-of-care conditions
- Primary endpoint relapse-free survival with overall and event-free survival as key secondary measures
Negative
- None.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 22 | Phase 1 data | Positive | -6.0% | Positive Cohort C results preceded a reported -5.97% 24-hour price reaction |
| Dec 06 | Phase 1 data | Positive | -7.4% | Updated Phase 1 results preceded a reported -7.41% 24-hour price reaction |
| Dec 03 | Clinical update event | Positive | +6.9% | Planned clinical update event preceded a reported 6.86% 24-hour price reaction |
| Nov 05 | Phase 1 data | Positive | +4.1% | Preliminary trial findings preceded a reported 4.13% 24-hour price reaction |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
TScan's tag-specific clinical-trial announcements produced mixed reactions, with two positive updates followed by declines and two followed by gains.
Key Terms
tcr-t technical
allo-hct medical
genetic randomization medical
relapse-free survival medical
event-free survival medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Actively enrolling patients across the US with anticipated topline data readout mid-2028
WALTHAM, Mass., July 29, 2026 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today announced that the first patient has been infused with TSC-101 in the pivotal Phase 3 ALLOHA-2™ trial (NCT07702578). The patient, who was enrolled in June, has now received their first infusion of TSC-101 following successful stem cell engraftment. The trial is investigating the efficacy and safety of TSC-101 for the treatment of residual disease to prevent relapse following allogeneic hematopoietic cell transplantation (allo-HCT) in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
“Dosing our first patient in the ALLOHA-2™ study is a significant milestone for TScan. Having been a part of TScan as we moved TSC-101 from an idea to Discovery, through Phase 1 clinical development, and now to a Phase 3 study, I want to acknowledge all the hard work that went into bringing TSC-101 to this integral step and congratulate all current and previous members of the TScan team,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “I would also like to thank the investigators, the patients, and their families for participating in our Phase 1 ALLOHA™ trial. In June, we reported initial data from Cohort C of that study, in which patients were treated with our commercial-ready manufacturing process. The strong clinical efficacy and positive safety profile observed in this cohort gives us added confidence in our Phase 3 trial and future clinical development plans.”
“TSC-101 has demonstrated a safety profile and clinical results that continue to excite the transplant community,” said Chrystal U. Louis, M.D., Chief Medical Officer. “The pace of Cohort C enrollment highlights the growing interest in TSC-101 as a potential therapeutic option for people with AML or MDS, and we look forward to working with our investigators to address residual disease and improve survival in patients after allo-HCT.”
The Phase 3 ALLOHA-2™ pivotal trial is a study evaluating TSC-101 administered after standard of care HCT vs HCT alone in patients with AML or MDS. Treatment is based on biological assignment (genetic randomization), with A*02:01-positive subjects with an appropriate donor assigned to the treatment arm, and A*02:01-negative subjects, or A*02:01-posititve subjects without an appropriate donor, assigned to the control arm. All subjects will receive HCT with reduced intensity conditioning. Subjects in the treatment arm will receive two infusions of TSC-101 following engraftment. The primary endpoint for the study is relapse-free survival, and key secondary endpoints include overall survival and event-free survival.
To learn more about the ALLOHA-2™ clinical trial, visit clinicaltrials.gov (identifier: NCT07702578).
About TScan Therapeutics, Inc.
TScan is a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer. The Company’s lead TCR-T therapy candidate, TSC-101, is in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation (the ALLOHA-2™ Phase 3 pivotal trial). The Company is also in early stages of developing methods for in vivo engineering to treat solid tumors. In addition, the Company is applying its target discovery platform to discover novel targets in various T cell-mediated autoimmune disorders.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding TScan Therapeutics, Inc.’s (“TScan” or the “Company”) plans, progress, expectations, and timing relating to the Company’s hematologic malignancies program, including clinical updates of the ALLOHA-2TM clinical trial, presentation of data, enrollment and dosing of patients, and market opportunities; the progress of the hematologic malignancies program being indicative or predictive of the success of such program; the structure, timing and success of the ALLOHA-2TM clinical trial; the potential benefits of any of the Company’s proprietary platforms or current or future product candidates in treating patients; and the Company’s goals, strategy and anticipated financial performance. TScan intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “on track,” or similar expressions or the negative of those terms. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. The express or implied forward-looking statements included in this release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: the beneficial characteristics, safety, efficacy, therapeutic effects and potential advantages of TScan’s TCR-T therapy product candidates; TScan’s expectations regarding its preclinical studies being predictive of clinical trial results; TScan’s approved INDs being indicative or predictive of bringing TScan closer to its goal of providing customized TCR-T therapies to treat patients with cancer; the timing of the launch, initiation, progress, expected results and announcements of TScan’s preclinical studies, clinical trials and its research and development programs; TScan’s ability to enroll patients for its clinical trials within its expected timeline; TScan’s plans relating to developing and commercializing its TCR-T therapy product candidates, if approved, including sales strategy; estimates of the size of the addressable market for TScan’s TCR-T therapy product candidates; TScan’s manufacturing capabilities and the scalable nature of its manufacturing process; TScan’s estimates regarding expenses, future milestone payments and revenue, capital requirements and needs for additional financing; TScan’s expectations regarding competition; TScan’s anticipated growth strategies; TScan’s ability to attract or retain key personnel; TScan’s ability to establish and maintain development partnerships and collaborations; TScan’s expectations regarding federal, state and foreign regulatory requirements; TScan’s ability to obtain and maintain intellectual property protection for its proprietary platform technology and our product candidates; the sufficiency of TScan’s existing capital resources to fund its future operating expenses and capital expenditure requirements; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of TScan’s most recent Annual Report on Form 10-K and any other filings that TScan has made or may make with the SEC in the future. Any forward-looking statements contained in this release represent TScan’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, TScan explicitly disclaims any obligation to update any forward-looking statements.
Investor and Media Contact
Caileigh Dougherty
AVP, Head of Corporate Communications & Investor Relations
857-399-9890
cdougherty@tscan.com
