Actively Recruiting
A Controlled Multi-Arm Phase 1 Umbrella Study Evaluating the Safety and Feasibility of T-Cell Receptor Engineered Donor T-Cells Targeting HA1 (TSC-100) or HA2 (TSC-101) in HLA-A0201 Positive Patients Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
Led by TScan Therapeutics, Inc. · Updated on 2026-04-08
75
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of two genetically engineered donor-derived T cell therapies, TSC-100 and TSC-101, in patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or acute lymphoblastic leukemia (ALL) who are undergoing allogeneic peripheral blood stem cell transplantation. This Phase 1, multi-center, open-label umbrella study is designed to assess these treatments combined with the standard of care, compared to the standard of care alone, following hematopoietic cell transplantation (HCT) from haploidentical donors or matched unrelated donors (MUD or MMUD). The study focuses on patients positive for HLA A*02:01 and aims to determine the optimally tolerated dose and preliminary efficacy of these T cell therapies. Participants receive either TSC-100 or TSC-101 based on their HLA type and minor antigen positivity, or standard of care alone. The treatments are administered intravenously alongside standard reduced intensity conditioning regimens such as fludarabine with cyclophosphamide and total body irradiation, or other institutional protocols. Dose escalation follows an interval 3+3 design to evaluate safety and tolerability, with up to two doses given. Once the recommended phase 2 dose is identified, additional patients may be enrolled at that dose level. Supportive care and infectious prophylaxis are provided per institutional guidelines. During the study, participants will undergo safety evaluations including monitoring for dose-limiting toxicities and adverse events over a two-year follow-up period. Researchers will assess disease-free survival, relapse rates, overall survival, and immune responses to the therapies at various intervals up to two years. Participants must consent to mandatory procedures such as bone marrow biopsies and blood sampling for research and agree to long-term follow-up for up to 15 years if receiving the investigational T cell infusion. The study involves careful monitoring and comparison of outcomes between treatment and control groups to evaluate the investigational therapies' potential.
CONDITIONS
Brief Title
A Study of TSC-100 and TSC-101 in AML, ALL and MDS in Patients Undergoing Allogeneic Peripheral Blood Stem Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at the time of signing the informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at screening
- Use of contraception as per local regulations during the study and for at least 12 months after last dose
- Male participants must agree to use highly effective contraception during and for 12 months after treatment and avoid sperm donation
- Female participants must not be pregnant or breastfeeding and either not be of childbearing potential or agree to contraceptive guidance during and 12 months after treatment
- Preparing to undergo allogeneic hematopoietic cell transplantation for AML, MDS, or ALL
- Treatment arm participants must be HLA-A*02:01 positive; control arm participants may have any HLA type
- Possess HA-1 positive genotype to be eligible for TSC-100 or HA-2 positive genotype to be eligible for TSC-101
- Have a haploidentical donor, mismatched unrelated donor (MMUD), or matched unrelated donor (MUD) meeting donor criteria
- Clinically indicated for haploidentical donor, MMUD, or MUD transplantation, reduced intensity conditioning, and peripheral blood stem cell transplantation
- Meet organ function requirements per institutional standards
- Capable of giving signed informed consent including compliance with study procedures
- Agree to mandatory study procedures including bone marrow biopsy and blood sampling
- Agree to long-term follow-up for up to 15 years after initial treatment if receiving investigational T cell infusion
You will not qualify if you...
- Medical or psychological conditions making the participant unsuitable for cell therapy including uncontrolled malignancy or active central nervous system disease
- Participants with donor-specific HLA antibodies considered high enough to require desensitization and no alternative donors
- Participants positive for HLA-A*02:07 who meet criteria for TSC-101
- Evidence of clinically significant infection or uncontrolled viral reactivation of CMV, EBV, Adenovirus, BK virus, or human herpesvirus 6
- Active cardiac disease including recent angina, significant arrhythmias, recent myocardial infarction, or uncontrolled heart failure
- Prior allogeneic hematopoietic cell transplantation
- History of hypersensitivity to murine proteins
- Enrollment in another trial with a novel investigational agent
- Use of anti-thymocyte globulin, alemtuzumab, or other T-cell depleting agents from Day -14 through end of study
- Donors positive for any HLA-A02 allele except HA-1 negative for TSC-100 or any HLA-A02 allele for TSC-101
- Donors testing positive for HIV, HTLV, hepatitis B or C, syphilis, West Nile virus, or other specified infections
- Related donors residing outside the USA unless screening and procedures can be done at the treatment site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 40 days for dose limiting toxicity evaluation; treatment may include repeated dosing as determined by safety review committee
Participants receive either TSC-100 or TSC-101 combined with standard of care, or standard of care alone, including reduced intensity conditioning, hematopoietic cell infusion, and acute graft-versus-host disease prophylaxis.
Multiple visits during and shortly after treatment for dosing and safety evaluations
Duration - Up to 2 years
Participants are monitored for safety, adverse events, disease-free survival, relapse rates, overall survival, and immunogenicity for up to 2 years after treatment.
Regular visits for safety and efficacy assessments over 2 years
Trial Site Locations
Total: 15 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Yale
New Haven, Connecticut, United States, 06510
Actively Recruiting
3
Memorial Healthcare System
Hollywood, Florida, United States, 33021
Actively Recruiting
4
Northside Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
5
John Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
6
Mass General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
8
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
9
Columbia University
New York, New York, United States, 10027
Actively Recruiting
10
Mount Sinai
New York, New York, United States, 10029-6696
Actively Recruiting
11
University North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
12
UPenn
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
13
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
14
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
15
Froedert and Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
J
Jim Murray
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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