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Phase 1/3 Study of T-Cell Receptor Engineered Donor T Cells for AML and MDS

This study is testing two new treatments, TSC-100 and TSC-101, alongside standard care for people with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) who are having a stem cell transplant. TSC-100 and TSC-101 are special donor T cells (a type of immune cell) that have been engineered to target specific proteins (HA-1 or HA-2) found in some patients. The study aims to find out if these treatments are safe and what dose works best. Researchers will also look at how well they work compared to standard care alone. You may be eligible if you are 18 or older and meet certain health criteria. The study is currently unclear on its recruitment status.

Study design
This is a Phase 1 study with multiple groups, where some participants receive TSC-100 or TSC-101 with standard care, and others receive standard care alone. It is an open-label study, meaning you and your doctors will know which treatment you are receiving. The study plans to enroll 310 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor participants for side effects and dose-limiting toxicities for up to 2 years after treatment.

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

NCT05473910

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
TScan Therapeutics, Inc.
~310 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:SOC + TSC-101ControlSOC + TSC-100

At a glance

Recruiting sites
21 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of dose limiting toxicities
Measured over 2 years
+1 more outcome measured

Conditions

AML
MDS

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Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaMyelodysplastic SyndromeHLA-A GeneKERATIN 31, TYPE IUnconventional Myosin-Ig

Where it's being run

21 sites across 15 states
Texas3
Colorado2
Florida2
Massachusetts2
New York2
California1
Connecticut1
Georgia1

Study leadership

  • Shrikanta Chattopadhyay, MD · STUDY_DIRECTOR · Tscan Therapeutics

Who to contact

Tim White
[email protected]
(857) 399-9500
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female aged ≥ 18 years at the time of signing the informed consent.
Eastern Cooperative Oncology Group (ECOG)-PS ≤ 2 at the time of the screening visit.
Contraceptive use by male and female participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Male Participants:
A male participant must agree to use a highly effective contraceptive as detailed in Appendix 4 of this protocol during the intervention period and for at least 12 months after the last dose of study intervention and refrain from donating sperm during this period.
Female Participants:
A female participant 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) OR
A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 12 months after the last dose of study intervention.
Preparing to undergo allogeneic HCT for either of the following:
AML, MDS, ALL
Participants in the treatment arms must express HLA-A\*0201. Participants in the control arm may express any HLA type.
Having the HA1+/- or HA-1+/+ (HA-1 positive) genotype to be eligible for TSC-100 treatment.
Having the HA2+/- HA-2+/+ (HA-2 positive) genotype to be eligible for TSC-101 treatment.

What this trial measures

  • Occurrence of dose limiting toxicities2 years

    Number of DLTs observed in patients compared to the control arm

  • Occurrence of adverse events2 years

    Number of adverse events in patients compared to control arm