A Phase 1-3 Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA-2)

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
TScan Therapeutics, Inc.
Study ID
NCT07702578
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TSC-101 — DRUG
    SOC + TSC-101
  • Control — OTHER
    SOC alone

Study Details

This is a multicenter, genetically-randomized, controlled, Phase 3 study evaluating the efficacy and safety of T-cell receptor-engineered donor T cells targeting HA-2 (TSC-101) administered following reduced-intensity conditioning (RIC) hematopoietic cell transplantation (HCT) in participants with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). The study will compare TSC-101 plus standard of care (SOC) versus SOC alone in participants undergoing allogeneic peripheral blood stem cell transplantation from haploidentical or mismatched unrelated donors.

Key Dates

First listed
Jul 14, 2026
Start date
Jun 18, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
310 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm (TSC-101)
    Participants who are HLA-A\*02:01-positive and undergoing reduced intensity conditioning hematopoietic stem cell transplantation using allogeneic HLA-A\*02 negative donors.
  • Active Comparator: Control Arm (Standard of Care)
    1. Participants who are not HLA-A\*02:01-positive, HA-2-positive, or who are treatment-arm eligible but for whom an HLA-A\*02-negative donor cannot be identified, will be assigned to the control arm and receive allo-HCT alone. 2. Participants who are HLA-A\*02:01 negative, will be assigned to the control arm and receive allo-HCT alone.

Primary Outcome Measure

Relapse-free survival (RFS) [ Time Frame: 3 years ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Banner Health - MD Anderson Cancer CenterGilbertArizona85234
Yazan Samhouri, MD (PRINCIPAL_INVESTIGATOR)
Honor Health Cancer Transplant InstituteScottsdaleArizona85258
Abdullah Ladha, MD (PRINCIPAL_INVESTIGATOR)
City of HopeDuarteCalifornia91010
Monzr M Al Malki, MD (PRINCIPAL_INVESTIGATOR)
Stanford - School of MedicineStanfordCalifornia94305
Hany Elmariah, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado - Anschutz Cancer CenterAuroraColorado80045
Mathew Angelos, MD (PRINCIPAL_INVESTIGATOR)
SCRI - Colorado Blood Cancer InstituteDenverColorado80218
Marcello Rotta, MD (PRINCIPAL_INVESTIGATOR)
YaleNew HavenConnecticut06510
Lohith Gowda, MD (PRINCIPAL_INVESTIGATOR)
Memorial Cancer InstituteHollywoodFlorida33021
Hugo Fernandez, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer InstituteTampaFlorida33612
Nelli Bejanyan, MD (PRINCIPAL_INVESTIGATOR)
Northside HospitalAtlantaGeorgia30342
Melholm Sohl, MD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60607
Gregory Roloff, MD (PRINCIPAL_INVESTIGATOR)
The University of Kansas Cancer CenterKansas CityKansas66160
Rajat Bansal, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21287
Tania Jain, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer Institute - Hematology/OncologyBostonMassachusetts02215
Mahasweta Gooptu, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Yi-Bin Chen, MD (PRINCIPAL_INVESTIGATOR)
Karmanos Cancer InstituteDetroitMichigan48201
Joseph Uberti, MD (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Michele Donato, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gilbert, AZ

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Banner Health - MD Anderson Cancer Center· Gilbert, AZHonor Health Cancer Transplant Institute· Scottsdale, AZCity of Hope· Duarte, CAStanford - School of Medicine· Stanford, CAUniversity of Colorado - Anschutz Cancer Center· Aurora, COSCRI - Colorado Blood Cancer Institute· Denver, CO

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