Drugs / TSC-101
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | hematopoietic and lymphoid cell neoplasm | 2022-01-24 | “The Company received a brief communication from the FDA indicating that the TSC-101 IND has been placed on hold” tscan.com ↗ “As previously disclosed, the FDA placed a clinical hold on the IND for TSC-101 in January 2022.” tscan.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05473910 | Nov 2022 → Jun 2026 overdue | acute myeloid leukemia, myelodysplastic syndrome | TScan Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07702578 | Jun 2026 → Jun 2029 expected | acute myeloid leukemia, myelodysplastic syndrome | TScan Therapeutics, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2026-09-02 | TScan Therapeutics, Inc. | Results TScan Therapeutics Announces Strategic Reorganization to Focus on in vivo Cell Therapy for Solid Tumors tscan.com ↗
All patients (13/13) currently being tracked show complete donor chimerism, including two patients who had previously relapsed. |
| 2026-06-22 | TScan Therapeutics, Inc. | Results TScan Therapeutics Announces Positive Initial Data from Cohort C of Ongoing ALLOHA™ Phase 1 Study Evaluating TSC-101 in Patients with Heme Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation tscan.com ↗
Furthermore, even in a higher-risk patient population when compared to patients in Cohort A and our control arm, 93% of patients responded to TSC-101 with decreasing recipient chimerism. |
| 2025-12-06 | TScan Therapeutics, Inc. | Results TScan Therapeutics Announces Positive Updated Data from the ALLOHA™ Phase 1 Heme Trial at the 67th American Society of Hematology Annual Meeting and Exposition tscan.com ↗
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 updated results from the ongoing ALLOHA™ Phase 1 trial ( NCT05473910 ) of TSC-101 in patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation (HCT). |
| 2025-11-03 | TScan Therapeutics, Inc. | Regulatory TScan Therapeutics Reaches Agreement with FDA on Pivotal Study Design for TSC-101 and Announces Strategic Prioritization to Advance TSC-101 and Extend Cash Runway into H2 2027 tscan.com ↗
Following a productive End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA), the Company has reached alignment on the registrational path forward for the TSC-101 program as a treatment for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). |
| 2024-12-09 | TScan Therapeutics, Inc. | Results TScan Therapeutics to Present Updated Data from the Ongoing ALLOHA™ Phase 1 Heme Trial During Oral Session at the 66th American Society of Hematology Annual Meeting and Exposition tscan.com ↗
To date, event-free survival strongly favors the treatment arm (HR=0.30; p=0.04), and treatment-arm patients trend towards lower probability of relapse (HR=0.28; p=0.14) |
| 2024-11-05 | TScan Therapeutics, Inc. | Results TScan Therapeutics Announces Upcoming Oral Presentation of Data from the ALLOHA™ Phase 1 Heme Trial at the 66th American Society of Hematology Annual Meeting and Exposition tscan.com ↗
TSC-100 and TSC-101 were designed with this significant unmet need in mind, and preliminary clinical and translational data from the ALLOHA trial supports the safety and potential of TSC-100 and TSC-101 to reduce relapses and increase relapse-free survival. |
| 2024-08-12 | TScan Therapeutics, Inc. | Regulatory TScan Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update tscan.com ↗
FDA grants RMAT designation to TSC-100 and TSC-101 for the treatment of patients with AML, ALL, and MDS undergoing allogeneic HCT with reduced intensity conditioning |
| 2024-05-29 | TScan Therapeutics, Inc. | Regulatory TScan Therapeutics Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for its Two Lead TCR-T Therapy Candidates for the Treatment of Heme Malignancies tscan.com ↗ |
| 2024-04-16 | TScan Therapeutics, Inc. | Results TScan Therapeutics Provides Clinical Pipeline Update and Highlights Near-Term Priorities tscan.com ↗
All eight patients treated with TSC-100 or TSC-101 remain MRD negative, relapse-free with no detectable cancer to date in either bone marrow biopsies or peripheral blood (median follow-up of >10 months) and no dose limiting toxicities observed to date. |
| 2024-03-06 | TScan Therapeutics, Inc. | Results TScan Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update tscan.com ↗
Presented updated data from ongoing Phase 1 study of TSC-100 and TSC-101 for the treatment of heme malignancies at the Tandem Meetings of ASTCT and CIBMTR; 8/8 (100%) patients in treatment arms are relapse-free and show complete donor chimerism |
| 2024-02-26 | TScan Therapeutics, Inc. | Results TScan Therapeutics Presents Promising Updated Phase 1 Clinical Results on TSC-100 and TSC-101 at the 2024 Tandem Meetings of ASTCT and CIBMTR tscan.com ↗
All eight (100%) treatment-arm patients are relapse-free and have achieved and maintained complete donor chimerism following treatment with TSC-100 or TSC-101 |
| 2023-12-09 | TScan Therapeutics, Inc. | Results TScan Therapeutics Presents Initial Phase 1 Clinical Results on TSC-100 and TSC-101 at the 65th American Society of Hematology Annual Meeting and Exposition tscan.com ↗
AML patient with detectable disease post-transplant converted to no detectable disease following treatment with TSC-101 |
| 2023-05-17 | TScan Therapeutics, Inc. | Results TScan Therapeutics Presents Preliminary Phase 1 Clinical Results on TSC-100 and TSC-101 at the American Society of Gene & Cell Therapy 26th Annual Meeting tscan.com ↗
Poster highlights Phase 1 results following treatment with TSC-100 and TSC-101 after hematopoietic cell transplantation |
| 2022-05-31 | TScan Therapeutics, Inc. | Regulatory TScan Therapeutics Announces FDA Clearance of Investigational New Drug Application for TSC-101 for the Treatment of Hematologic Malignancies tscan.com ↗ |
| 2022-01-24 | TScan Therapeutics, Inc. | Regulatory TScan Therapeutics Announces FDA Clearance of Investigational New Drug Application for TSC-100 for the Treatment of Hematologic Malignancies tscan.com ↗
The Company received a brief communication from the FDA indicating that the TSC-101 IND has been placed on hold pending additional assessment of the risk of off-tumor reactivity for TSC-101. |
| 2022-01-10 | TScan Therapeutics, Inc. | Regulatory TScan Outlines 2022 Priorities as Programs Enter Clinic tscan.com ↗
As forecasted, in December 2021 TScan filed INDs for TSC-100 and TSC-101, its TCR-T programs to prevent relapse in leukemia patients following hematopoietic cell transplants. |
All press releases naming this drug 21 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TSC-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07702578 ↗ |
| Modality | Cell therapy | “TSC-100 and TSC-101 is a genetically engineered, donor-derived T cell targeting HA-1 and HA-2 respectively” NCT05473910 ↗ |
| Route | Intravenous | “TSC-100 or TSC-101 will be administered intravenously” NCT05473910 ↗ |