Supercharged donor cells aim to stop leukemia return after transplant

NCT ID NCT07702578

Cure Sponsor: TScan Therapeutics, Inc. Source: ClinicalTrials.gov ↗

First seen Jul 14, 2026 · Last updated Jul 23, 2026 · Updated 5 times

Summary

This study tests a new approach to prevent leukemia from coming back after a stem cell transplant. It uses donor T cells that have been engineered to recognize and attack a specific target (HA-2) on leukemia cells. The trial enrolls adults with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) who are receiving a stem cell transplant from a partially matched donor. Half receive the engineered cells plus standard care, and half receive standard care alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: TSC-101, a T-cell receptor engineered donor T cell therapy targeting HA-2
What this could lead to: If successful, TSC-101 could reduce the risk of leukemia relapse after stem cell transplant, potentially leading to higher cure rates for AML and MDS.
What could go wrong: This is an early-phase trial, so the benefits are not proven. There may be risks like graft-versus-host disease or other immune reactions. The therapy only works for patients with a specific genetic marker (HLA-A*02:01).

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 310 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Subject Inclusion Criteria: 1. Patient aged ≥ 18 years at the time of signing informed consent. 2. Karnofsky Performance Status (KPS) ≥50 at the time of the screening visit. 3. Undergoing first allo-HCT with a diagnosis of: * AML with bone marrow blasts \< 5%, absence of circulating blasts, and absence of extramedullary disease. * MDS 4. Must express HLA-A\*02:01 as determined by pre-transplant institutional SOC work-up to be eligible for the treatment arm. 5. Must have the HA-2 positive genotype to be eligible for the treatment arm. 6. 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. 7. Undergoing use of PTCy for GvHD prophylaxis at standard doses. 8. Use of peripheral blood stem cell source. 9. 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. 10. 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. 11. 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. 12. Contraceptive use by male and female subjects must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. At a minimum: * A male subject must agree to use a highly effective contraceptive during the intervention period and for at least 12 months after the last TSC-101 infusion and refrain from donating sperm during this period. * A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: * Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 OR * A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the intervention period and for at least 12 months after the last TSC-101 infusion. Subject Exclusion Criteria: Patients are excluded from the study if any of the following criteria apply: 1. 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). 2. For patients with AML: those in third complete remission (CR3) or greater, partial remission, or with active AML disease. 3. If patient required hemodialysis or mechanical ventilation within 3 months prior to enrollment, circumstances must be discussed with the Sponsor Medical Monitor. 4. Prior allo-HCT. 5. 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. 6. History of hypersensitivity to murine proteins. 7. Enrollment in a concomitant study with an investigational agent. All other concomitant trials must be reviewed and approved by the Medical Monitor. 8. Cardiac disease, defined as: * Uncontrolled or symptomatic angina within the past 3 months. * History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes). Atrial fibrillation with controlled ventricular response on treatment is not an exclusion. * 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). 9. 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: * Lobular breast carcinoma in situ, fully resected basal cell or squamous cell carcinoma of skin or treated cervical carcinoma in situ will be allowed. Cancer treated with curative intent ≥ 3 years previously will be allowed Donor Inclusion Criteria: 1. Male or female ≥ 50 kg and aged ≥ 16 years at the time of signing informed consent who meet the criteria to donate as per the institutional SOC. 2. Capable of giving signed informed consent, or assent/parental consent per institutional SOC, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 3. For treatment-arm donors: able to undergo peripheral blood stem cell (PBSC) collection and at least 2 rounds of leukapheresis (for both TSC-101 manufacturing and the stem cell collection for HCT). 4. For treatment-arm donors: negative for all HLA-A\*02 alleles • Donors for control-arm subjects do not have to be negative for HLA-A\*02 alleles. Donor Exclusion Criteria: 1. Donors for control-arm subjects who do not meet institutional standards for donor selection. 2. Donors for treatment-arm subjects: * Who test positive for any of the following: human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2, seropositive or with active hepatitis B or hepatitis C virus infection, syphilis, West Nile virus through central lab testing. Donors who screen positive for Creutzfeldt Jakob disease using donor history questionnaires will also be excluded. Donors with evidence of past cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infections will be allowed. * For whom the treating Investigator deems subject level donor-specific HLA antibodies are high enough to warrant treatment with desensitization protocols.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AML MDS

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

26 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Banner Health - MD Anderson Cancer Center
NOT_YET_RECRUITING

Gilbert, Arizona, 85234, United States
Baylor University Medical Center
RECRUITING

Dallas, Texas, 75246, United States
City of Hope
RECRUITING

Duarte, California, 91010, United States
Columbia University - Irving Medical Center
RECRUITING

New York, New York, 10032, United States
Dana-Farber Cancer Institute - Hematology/Oncology
RECRUITING

Boston, Massachusetts, 02215, United States
Froedtert & Medical College of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Hackensack University Medical Center
RECRUITING

Hackensack, New Jersey, 07601, United States
Honor Health Cancer Transplant Institute
NOT_YET_RECRUITING

Scottsdale, Arizona, 85258, United States
Hospital of the University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Johns Hopkins University
RECRUITING

Baltimore, Maryland, 21287, United States
Karmanos Cancer Institute
RECRUITING

Detroit, Michigan, 48201, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Memorial Cancer Institute
RECRUITING

Hollywood, Florida, 33021, United States
Moffitt Cancer Institute
RECRUITING

Tampa, Florida, 33612, United States
Mount Sinai Hospital
RECRUITING

New York, New York, 10029, United States
Northside Hospital
RECRUITING

Atlanta, Georgia, 30342, United States
SCRI - Colorado Blood Cancer Institute
RECRUITING

Denver, Colorado, 80218, United States
Sarah Cannon Research Institute - TriStar Bone Marrow Transplant (BMT)
RECRUITING

Nashville, Tennessee, 37203, United States
St. David's South Austin Medical Center
RECRUITING

Austin, Texas, 76704, United States
Stanford - School of Medicine
NOT_YET_RECRUITING

Stanford, California, 94305, United States
The University of Kansas Cancer Center
NOT_YET_RECRUITING

Kansas City, Kansas, 66160, United States
The University of North Carolina at Chapel Hill
RECRUITING

Chapel Hill, North Carolina, 27599, United States
The University of Texas - MD Anderson Cancer Center
RECRUITING

Houston, Texas, 76704, United States
University of Chicago
NOT_YET_RECRUITING

Chicago, Illinois, 60607, United States
University of Colorado - Anschutz Cancer Center
RECRUITING

Aurora, Colorado, 80045, United States
Yale
RECRUITING

New Haven, Connecticut, 06510, United States

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