TSC-101
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December 19, 2024
TSC-100 and TSC-101 Demonstrate the Potential to Reduce Relapse Rates and Increase Relapse-Free Survival in Patients with AML, ALL, or MDS Undergoing Allogeneic Hematopoietic Cell Transplantation (HCT) with Reduced Intensity Conditioning (RIC): Preliminary Results from the Phase 1 Alloha Trial (NCT05473910)
(TCT-ASTCT-CIBMTR 2025)
- P1 | "The data support the safety and potential of TSC-100/TSC-101 to reduce relapses and increase event-free and relapse-free survival in patients with AML, ALL and MDS undergoing RIC HCT. Enrollment continues and updated data will be presented."
Clinical • P1 data • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Infectious Disease • Myelodysplastic Syndrome • Transplantation
July 29, 2026
TScan Therapeutics Announces First Patient Dosed in Phase 3 ALLOHA-2™, a Pivotal Trial Evaluating TSC-101 in Patients with Heme Malignancies
(The Manila Times)
Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome
July 14, 2026
A Phase 1/3 Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA-2)
(clinicaltrials.gov)
- P1 | N=310 | Recruiting | Sponsor: TScan Therapeutics, Inc. | N=75 ➔ 310 | Trial completion date: Jun 2026 ➔ Jun 2028
Enrollment change • Trial completion date • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Transplantation • HLA-A
July 15, 2026
A Phase 1-3 Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA-2)
(clinicaltrials.gov)
- P3 | N=310 | Recruiting | Sponsor: TScan Therapeutics, Inc.
New P3 trial • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Transplantation • HLA-A
April 13, 2026
Novel CD45-targeted TCR-T cell therapies designed to eliminate residual disease and prevent relapse following allogeneic hematopoietic cell transplantation
(ASGCT 2026)
- P1 | "One such investigational product, TSC-101, targets the HA-2 minor histocompatibility antigen that is present on all blood cells. Conclusion As TSC-102-A01 and TSC-102-A03 TCR-T cells display highly specific and potent in vitro activity with no projected allo- or off-target activity, TScan is advancing these TCR-T cell therapies to clinical development. By expanding our portfolio of TCR-T cell therapies to include products that could treat HLA-A*02:01-, HLA-A*01:01-, or HLA-A*03:01-positive patients, we anticipate that ~70% of the US population undergoing HCT for hematologic malignancies could be eligible for a TCR-T cell therapy designed to prevent relapse."
Residual disease • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Transplantation • HLA-A • PTPRC
April 09, 2026
ALLOHA: A Study of TSC-100 and TSC-101 in AML, ALL and MDS in Patients Undergoing Allogeneic Peripheral Blood Stem Transplantation
(clinicaltrials.gov)
- P1 | N=75 | Recruiting | Sponsor: TScan Therapeutics, Inc. | Trial primary completion date: Dec 2025 ➔ Jun 2026
Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • Transplantation • HLA-A
March 06, 2024
Trial in progress:A phase 1 trial of TSC-100 and TSC-101, engineered T cell therapies that target minor histocompatibility antigens to eliminate residual disease after hematopoietic cell transplantation
(AACR 2024)
- P1 | "Donor chimerism is measured by standard STR-based and novel high-sensitivity NGS-based assays to quantify residual patient-derived hematopoietic cells. Together, these assays measure elimination of residual patient hematopoietic cells, malignant or normal, and could provide early evidence of biological activity."
IO biomarker • P1 data • Residual disease • Hematological Malignancies • Oncology • HLA-A
February 26, 2026
TScan Therapeutics Completes Enrollment in Cohort C of Phase 1 ALLOHA™ Trial and Announces FDA Clearance of Investigational New Drug Applications for Heme Candidates TSC-102-A01 and TSC-102-A03
(The Manila Times)
- "The Company also announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) applications for TSC-102-A01 and TSC-102-A03 for patients with HLA types A*01:01 and A*03:01, respectively...TScan plans to share safety and early chimerism data from Cohort C in the second quarter of 2026. The Company also plans to launch a pivotal trial for TSC-101 in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in the second quarter of 2026...TScan plans to initiate a Phase 1 trial for both TSC-102-A01 and TSC-102-A03 in the second half of 2026."
Enrollment status • IND • New P1 trial • P1 data • Acute Myelogenous Leukemia • Myelodysplastic Syndrome
January 08, 2026
TSC-101 Eliminates Recipient Hematopoietic Cells and Demonstrates Potential for Improved Relapse-Free Survival in Patients with AML, ALL, or MDS Undergoing Allogeneic HCT (allo-HCT) with Reduced Intensity Conditioning (RIC): Updated Results from the Phase 1 (ALLOHA) Trial
(TCT-ASTCT-CIBMTR 2026)
- "The safety seen with HCT followed by TSC-101 is generally consistent with post-HCT safety. Preliminary analyses show early elimination of residual recipient cells in all evaluable subjects and support the potential of TSC-101 to reduce relapses and improve relapse-free survival in RIC-HCT patients. Updated data will be presented."
Clinical • P1 data • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Inflammation • Myelodysplastic Syndrome • CD33 • HLA-A • TP53
November 04, 2025
Trials in progress: Design of a registrational Phase 2 trial (ALLOHA) using an external control arm for TSC-101 for prevention of relapse post allogeneic HCT in patients with ALL, AML, or MDS
(ASH 2025)
- P1 | "Other endpoints will include OS, time to relapse,event-free survival, and exploratory biomarkers of efficacy. In conclusion, the ALLOHA study is designed to explore the novel paradigm of engineered TCR-T cellspost allogeneic HCT to eliminate residual disease cells, prevent relapse, and maximize long-termremission and survival."
Clinical • P2 data • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • HLA-A
November 04, 2025
TSC-101 eliminates recipient hematopoietic cells and demonstrates potential for improved relapse-free survival in patients with AML, ALL, or MDS undergoing allogeneic HCT: Updated results from the Phase 1 (ALLOHA) trial
(ASH 2025)
- P1 | "Preliminary analyses continue to show early elimination of residualrecipient cells in all evaluable subjects which further supports the potential of TSC-101 to reduce relapsesand improve relapse-free survival in RIC-HCT patients. Updated data will be presented."
Clinical • IO biomarker • P1 data • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • CD33 • HLA-A • TP53
December 06, 2025
TScan Therapeutics Announces Positive Updated Data from the ALLOHA Phase 1 Heme Trial at the 67th American Society of Hematology Annual Meeting and Exposition
(GlobeNewswire)
- "As of the September 19th, 2025 data cut, 42 patients (23 in the TSC-101 treatment arm and 19 in the control arm) were eligible for inclusion in the safety analysis set....Relapse-free survival (RFS) (HR=0.50; p=0.23) and overall survival (OS) (HR=0.61; p=0.52) were improved in the treatment arm relative to the control arm. 4 of 19 (21%) treatment-arm patients relapsed compared to 6 of 18 (33%) control-arm patients. One treatment-arm patient with AML experienced disease relapse on day 161 and was given a third dose of TSC-101 without lymphodepletion....All 3 (100%) TSC-101-treated patients that reached two years of follow-up remained relapse-free as of the data cutoff, compared to 1 of 4 (25%) patients in the control arm..."
P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome
December 03, 2025
TScan Therapeutics to Host Virtual KOL Event to Discuss Clinical Updates from the ALLOHA Phase 1 Trial and Future Market Opportunities
(GlobeNewswire)
- "The event will provide an in-depth review of the poster presented at the ASH Annual Meeting, including two-year relapse data on initial patients from TScan’s ongoing ALLOHA Phase 1 trial evaluating TSC-101 in patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation (HCT). The Company will discuss its improved commercial-ready manufacturing process that has recently been implemented in the ALLOHA Phase 1 trial and will be used in the upcoming pivotal trial scheduled to start in the second quarter of 2026."
Commercial • New trial • P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome
November 21, 2025
Highlights of JTCC Research to be presented at ASH 2025: Leukemia
(PRNewswire)
- "MRD-guided therapy of sonrotoclax (BGB-11417) + obinutuzumab (O) in patients with treatment-naive CLL: Initial results from an ongoing phase 1/1b study, BGB-11417-101 (ABSTRACT 25-7489); TSC-101 eliminates recipient hematopoietic cells and demonstrates potential for improved relapse-free survival in patients with AML, ALL, or MDS undergoing allogeneic HCT: Updated results from the Phase 1 (ALLOHA) trial (ABSTRACT 25-12098)."
Clinical data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Myelodysplastic Syndrome
November 03, 2023
Initial Results of a Phase 1 Trial of TSC-100 and TSC-101, Engineered T Cell Therapies That Target Minor Histocompatibility Antigens to Prevent Relapse after Allogeneic Hematopoietic Cell Transplantation
(ASH 2023)
- P1 | "Targeting MiHAs HA-1 or HA-2 with TSC-100/ 101 following HCT shows early safety and biomarker evidence of efficacy by completing elimination of all detectable patient hematopoietic cells, normal or malignant, thereby reducing relapse risk. Updated results will be presented at the meeting."
IO biomarker • P1 data • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Myelodysplastic Syndrome • Oncology • Transplantation • CD33 • HLA-A • TP53
November 06, 2024
TSC-100 and TSC-101 Demonstrate the Potential to Reduce Relapse Rates and Increase Relapse-Free Survival in Patients with AML, ALL, or MDS Undergoing Allogeneic HCT with Reduced Intensity Conditioning (RIC): Preliminary Results from the Phase 1 Alloha Trial
(ASH 2024)
- P1 | "The data support the safety and potential of TSC-100/TSC-101 to reduce relapses and increase event-free and relapse-free survival in RIC HCT patients. Enrollment continues and updated data will be presented."
Clinical • IO biomarker • P1 data • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Myelodysplastic Syndrome • Oncology • Septic Shock • CD33 • HLA-A
November 03, 2025
TScan Therapeutics Reaches Agreement with FDA on Pivotal Study Design for TSC-101 and Announces Strategic Prioritization to Advance TSC-101…
(GlobeNewswire)
- "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)....The updated pivotal trial design now includes a biologically assigned internal control arm instead of an external control arm using the CIBMTR registry. In the pivotal trial design, patients who are HLA-A*02:01-positive with an HLA-A*02-negative donor will be assigned to the investigational arm of the study, and patients who are HLA-A*02-01-negative or patients for which an HLA-mismatched donor cannot be found will be assigned to the control arm....The Company now expects the pivotal trial for TSC-101 to begin in Q2 2026."
Clinical protocol • FDA event • New trial • Acute Myelogenous Leukemia • Myelodysplastic Syndrome
May 06, 2025
TScan Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update
(TScan Therap Press Release)
- "Updates from the PLEXI-T solid tumor and ALLOHA heme Phase 1 clinical trials anticipated by end of year; On-track to file IND application for TSC-102-A0301 (CD45; HLA-A*03:01) to FDA in the second half of the year...Plans to present additional data from the ALLOHA Phase 1 trial by the end of the year, including two-year relapse data on the initial patients."
Commercial • IND • P1 data • Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Solid Tumor
November 03, 2025
Upcoming Anticipated Milestones
(GlobeNewswire)
- "Plans to present updated clinical data on Phase 1 ALLOHA trial at ASH on December 6, 2025, in Orlando, Florida. Plans to submit INDs for two additional TCR-T product candidates to expand HLA coverage of the heme program in Q4 2025. Plans to launch pivotal trial for TSC-101 for patients with AML and MDS in Q2 2026."
IND • New trial • P1 data • Acute Myelogenous Leukemia • Myelodysplastic Syndrome
March 05, 2025
TScan Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
(GlobeNewswire)
- "Heme Malignancies Program: TScan’s two lead TCR-T therapy candidates, TSC-100 and TSC-101...Opened expansion cohorts at dose level 3 to further characterize safety and evaluate translational and efficacy endpoints. Plans to continue development of TSC-101 only, as TSC-101 enables treatment of ~98% of patients with HLA type A*02:01. Initiate a registration trial for TSC-101, pending further feedback from regulatory authorities, in the second half of 2025. Plans to present additional data from the Phase 1 trial by the end of the year, including two-year relapse data on the initial patients. Plans to file an investigational new drug (IND) application for TSC-102-A0301, a TCR-T targeting CD45 on HLA-A*03:01, in the second half of 2025."
IND • New trial • P1 data • Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome
January 28, 2025
ALLOHA: A Study of TSC-100 and TSC-101 in AML, ALL and MDS Patients Undergoing Haploidentical Donor Transplantation
(clinicaltrials.gov)
- P1 | N=63 | Recruiting | Sponsor: TScan Therapeutics, Inc. | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025
Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • Transplantation • HLA-A
December 09, 2024
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
(GlobeNewswire)
- P1 | N=63 | ALLOHA (NCT05473910) | Sponsor: TScan Therapeutics, Inc. | "To date, 38 patients have been enrolled in the trial and undergone HCT....To date, event-free survival strongly favors the treatment arm (HR=0.30; p=0.04) and early trends suggest a lower probability of relapse (HR=0.28; p=0.14). 2 of 26 (8%) treatment-arm patients relapsed compared to 4 of 12 (33%) control-arm patients. One treatment-arm relapse and subsequent mortality occurred in a very high-risk patient who was taken to transplant without first achieving complete remission, and the other was an extramedullary relapse in the patient’s central nervous system with no evidence of systemic relapse....8 of 38 (21%) patients in the study had TP53 mutations, with 6 cases in the treatment arm and 2 cases in the control arm....TSC-100 and TSC-101 infusions were well-tolerated at all three dose levels with no dose-limiting toxicities."
P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome
December 02, 2024
TScan Therapeutics to Host Virtual KOL Event to Discuss Clinical Updates from the ALLOHA Phase 1 Trial and Heme Development Strategy
(GlobeNewswire)
- "TScan Therapeutics, Inc...announced the Company will host a virtual key opinion leader (KOL) event to discuss data from the ALLOHA Phase 1 heme trial presented at the ASH Annual Meeting and the clinical development strategy for the heme program. Additionally, the Company will provide an update on its PLEXI-T Phase 1 solid tumor trial. The virtual event will take place on Tuesday, December 10, at 8:00 a.m. ET. The event will provide an in-depth review of the oral presentation describing the preliminary results from TScan’s ongoing ALLOHA Phase 1 heme trial of TSC-100 and TSC-101 in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT) with reduced intensity conditioning."
P1 data • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Myelodysplastic Syndrome • Solid Tumor
November 12, 2024
TScan Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update
(GlobeNewswire)
- "Heme Malignancies Program: Plans to open expansion cohorts at the proposed recommended Phase 2 dose level to further characterize safety and evaluate translational and efficacy endpoints by the end of 2024; One-year clinical and translational data on initial patients to be reported by the end of 2024; Initiate a registration trial, pending feedback from regulatory authorities, and plans to report two-year clinical and translational data in 2025."
New trial • P1 data • Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome
November 05, 2024
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
(GlobeNewswire)
- P1 | N=63 | ALLOHA (NCT05473910) | Sponsor: TScan Therapeutics, Inc. | "As of the July 8, 2024 data cut, 27 patients were enrolled in the trial and had undergone HCT, with 16 in the treatment arm and 11 in the control arm. No relapses occurred in the treatment arm versus three relapses in the control arm. Median time to relapse was not evaluable in TSC-treated patients, where no relapses occurred, versus 159 days in the control arm. All five TSC-treated patients that reached one-year follow-up remained relapse-free and MRD negative as of the data cutoff, consistent with effective elimination of residual cancer cells post-HCT...Enrollment in the ALLOHA Phase 1 trial continues and updated data will be presented at the meeting in December...The Company will host a virtual KOL event featuring Ran Reshef....on Tuesday, December 10, 2024, at 8:00 a.m. ET to discuss the data presented at ASH..."
P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology
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