A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral … (NCT07702578) | Clinical Trial Compass
RecruitingPhase 3
A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
United States310 participantsStarted 2026-06-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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.
. Undergoing use of PTCy for GvHD prophylaxis at standard doses.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Potential treatment-arm patient is positive for 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.