NCT07702578

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P50-P75 for phase_3

Timeline
35mo left

Started Jun 2026

Typical duration for phase_3

Geographic Reach
1 country

26 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Jun 2029

Study Start

First participant enrolled

June 18, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 1, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

July 1, 2026

Last Update Submit

July 20, 2026

Conditions

AMLMDS

Keywords

HA-2TSC-101AMLMDSAdoptive Cell TherapyT-cell receptorT lymphocyteTCR-engineered T cellsbone marrow transplanthaploidenticalallogenic stem cell transplantBMTRICALLOHA-2Mismatched unrelated donors MMUDHCTHematopoietic cell transplantation

Outcome Measures

Primary Outcomes (1)

  • Relapse-free survival (RFS)

    To determine the efficacy of TSC-101 by assessing relapse-free survival (RFS)

    3 years

Secondary Outcomes (6)

  • Event-free survival (EFS)

    3 years

  • Overall survival (OS)

    3 years

  • Time to relapse (TTR)

    3 years

  • Changes over time in Quality of Life Score - EQ-5D-5L

    3 years

  • Changes over time in Quality of Life Score - FACT-Leu

    3 years

  • +1 more secondary outcomes

Other Outcomes (14)

  • Incidence and severity of treatment-emergent adverse events

    3 years

  • TSC-101 Expansion and Persistence

    3 years

  • Non-Relapse Mortality

    3 years

  • +11 more other outcomes

Study Arms (2)

Treatment Arm (TSC-101)

EXPERIMENTAL

Participants who are HLA-A\*02:01-positive and undergoing reduced intensity conditioning hematopoietic stem cell transplantation using allogeneic HLA-A\*02 negative donors.

Drug: TSC-101

Control Arm (Standard of Care)

ACTIVE COMPARATOR

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.

Other: Control

Interventions

TSC-101DRUG

SOC + TSC-101

Treatment Arm (TSC-101)
ControlOTHER

SOC alone

Control Arm (Standard of Care)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient aged ≥ 18 years at the time of signing informed consent.
  • Karnofsky Performance Status (KPS) ≥50 at the time of the screening visit.
  • Undergoing first allo-HCT with a diagnosis of:
  • AML with bone marrow blasts \< 5%, absence of circulating blasts, and absence of extramedullary disease.
  • MDS
  • Must express HLA-A\*02:01 as determined by pre-transplant institutional SOC work-up to be eligible for the treatment arm.
  • Must have the HA-2 positive genotype to be eligible for the treatment arm.
  • Undergoing RIC HCT using a haplo donor or MMUD.
  • Donors for treatment-arm subjects must be HLA-A\*02-negative.
  • Donors for control-arm subjects do not have to be HLA-A\*02-negative.
  • Undergoing use of PTCy for GvHD prophylaxis at standard doses.
  • Use of peripheral blood stem cell source.
  • Organ function parameters for transplant eligibility are met per institutional standards. Where organ function may fall outside of institutional standard for transplant, and patient is still proceeding to transplant, the case should be reviewed and approved by the MedicalMonitor.
  • Patient or legally authorized representative (LAR) capable of giving signed informed consent and willingness to comply with the requirements and restrictions listed in the informed consent form (ICF) and clinical protocol.
  • Agrees to participate in long-term follow-up (LTFU) for up to 15 years post the final infusion of TSC-101 if they receive a TSC-101 infusion.
  • +5 more criteria

You may not qualify if:

  • Patients are excluded from the study if any of the following criteria apply:
  • Potential treatment-arm patient is positive for HLA-A\*02:07.
  • Patients considered for the control arm can be positive for HLA-A\*02 (including HLA-A\*02:07).
  • For patients with AML: those in third complete remission (CR3) or greater, partial remission, or with active AML disease.
  • If patient required hemodialysis or mechanical ventilation within 3 months prior to enrollment, circumstances must be discussed with the Sponsor Medical Monitor.
  • Prior allo-HCT.
  • Use of anti-thymocyte globulin (ATG), alemtuzumab, or other in vivo or ex vivo T-cell depleting agents from Day -14 (pre-HCT) through end of study (EOS). Corticosteroids and maintenance therapies may be allowed under certain circumstances.
  • History of hypersensitivity to murine proteins.
  • Enrollment in a concomitant study with an investigational agent. All other concomitant trials must be reviewed and approved by the Medical Monitor.
  • Cardiac disease, defined as:
  • Uncontrolled or symptomatic angina within the past 3 months.
  • Myocardial infarction \< 6 months from study entry.
  • Uncontrolled or symptomatic congestive heart failure.
  • Cardiac ejection fraction at rest of less than 40% or shortening fraction of less than 22% by echocardiogram or radionuclide scan (multi-gated acquisition \[MUGA\] scan).
  • Medical or psychological conditions that would make the patient an unsuitable candidate for participation on a cell therapy trial, including active central nervous system disease and/or prior malignancy(s) within the last 3 years, except:
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Banner Health - MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

NOT YET RECRUITING

Honor Health Cancer Transplant Institute

Scottsdale, Arizona, 85258, United States

NOT YET RECRUITING

City of Hope

Duarte, California, 91010, United States

RECRUITING

Stanford - School of Medicine

Stanford, California, 94305, United States

NOT YET RECRUITING

University of Colorado - Anschutz Cancer Center

Aurora, Colorado, 80045, United States

RECRUITING

SCRI - Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

RECRUITING

Yale

New Haven, Connecticut, 06510, United States

RECRUITING

Memorial Cancer Institute

Hollywood, Florida, 33021, United States

RECRUITING

Moffitt Cancer Institute

Tampa, Florida, 33612, United States

RECRUITING

Northside Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60607, United States

NOT YET RECRUITING

The University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

NOT YET RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana-Farber Cancer Institute - Hematology/Oncology

Boston, Massachusetts, 02215, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Columbia University - Irving Medical Center

New York, New York, 10032, United States

RECRUITING

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Sarah Cannon Research Institute - TriStar Bone Marrow Transplant (BMT)

Nashville, Tennessee, 37203, United States

RECRUITING

St. David's South Austin Medical Center

Austin, Texas, 76704, United States

RECRUITING

Baylor University Medical Center

Dallas, Texas, 75246, United States

RECRUITING

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 76704, United States

RECRUITING

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Study Officials

  • Shrikanta Chattopadhyay, MD

    TScan Therapeutics

    STUDY DIRECTOR

Central Study Contacts

Marlyane Motta

CONTACT

(857) 399-9887mmotta@tscan.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Phase 3 genetically-randomized, controlled study designed to evaluate the efficacy of TSC-101 following RIC HCT vs. RIC HCT as standard of care (SOC).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 14, 2026

Study Start

June 18, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

July 22, 2026

Record last verified: 2026-07

Locations

US(26)