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A Study of TSC-101 for AML and MDS After Stem Cell Transplant

This study is testing a new treatment called TSC-101 for adults with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) who are having their first stem cell transplant. TSC-101 is a special type of donor T-cell therapy designed to help the body fight cancer. You would receive TSC-101 along with the usual care, or just the usual care alone. The study wants to see if TSC-101 can improve how long people live without their cancer returning (relapse-free survival) over 3 years. To join, you must be at least 18 years old, have AML or MDS, and be undergoing your first stem cell transplant. Some participants also need to have specific genetic markers (HLA-A*02:01 positive and HA-2 expression) and a donor who is HLA-A*02-negative.

Study design
This is a Phase 3 study that randomly assigns participants to receive either TSC-101 plus standard care or standard care alone. About 310 participants will be enrolled.
What's involved
Participants in the treatment arm will receive two infusions of TSC-101 after their transplant recovery. Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is to measure relapse-free survival at 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07702578

A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation

Recruiting
PHASE3Ages 18+InterventionalTreatment
TScan Therapeutics, Inc.
~310 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:TSC-101Control

At a glance

Recruiting sites
21 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relapse-free survival (RFS)
Measured over 3 years

Conditions

AML
MDS

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NCT07702578

Where you'd take part

This study runs at 26 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Banner Health - MD Anderson Cancer Center

    Gilbert, Arizonano site contact published

    Not yet recruiting

  • Baylor University Medical Center

    Dallas, Texasno site contact published

    Recruiting

  • City of Hope

    Duarte, Californiano site contact published

    Recruiting

  • Columbia University - Irving Medical Center

    New York, New Yorkno site contact published

    Recruiting

  • Dana-Farber Cancer Institute - Hematology/Oncology

    Boston, Massachusettsno site contact published

    Recruiting

  • Froedtert & Medical College of Wisconsin

    Milwaukee, Wisconsinno site contact published

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jerseyno site contact published

    Recruiting

  • Honor Health Cancer Transplant Institute

    Scottsdale, Arizonano site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Shrikanta Chattopadhyay, MD · STUDY_DIRECTOR · TScan Therapeutics

Who to contact

Marlyane Motta
[email protected]
(857) 399-9887
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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
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.

What this trial measures

  • Relapse-free survival (RFS)3 years

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