Actively Recruiting
A Study of TSC-100 and TSC-101 in AML, ALL and MDS in Patients Undergoing Allogeneic Peripheral Blood Stem Transplantation
Led by TScan Therapeutics, Inc. · Updated on 2026-04-08
75
Participants Needed
15
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, non-randomized, concurrent controlled, multi-arm, Phase 1 interventional, open-label, biologic assignment-based umbrella study evaluating the feasibility, safety and preliminary efficacy of an escalating dose regimen of up to 2 doses of TSC-100 and TSC-101 in patients with AML, MDS, or ALL following HCT from a haploidentical donor, MMUD, or MUD
CONDITIONS
Official 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 �3E= 18 years at the time of signing the informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at screening.
- Use of contraception consistent with local regulations during the study and for 12 months after last dose.
- Male participants must agree to use highly effective contraception and avoid sperm donation during the study and for 12 months after.
- Female participants must not be pregnant or breastfeeding and either not be of childbearing potential or agree to contraception during the study and for 12 months after.
- Preparing to undergo allogeneic hematopoietic cell transplantation for AML, MDS, or ALL.
- Participants in treatment arms must express HLA-A*0201; control arm participants may have any HLA type.
- HA-1 positive genotype for TSC-100 treatment eligibility.
- HA-2 positive genotype for TSC-101 treatment eligibility.
- Having a haploidentical donor, MMUD, or MUD adequately HLA-matched.
- Clinically indicated for haploidentical donor, MMUD, or MUD transplantation per investigator.
- Clinically indicated for reduced intensity conditioning per investigator.
- Clinically indicated for peripheral blood stem cell transplantation per investigator.
- Meeting institutional standards for organ function eligibility for transplantation.
- Able to provide signed informed consent including compliance with study requirements.
- Agree to mandatory study procedures including bone marrow biopsy and blood sampling.
- Agree to long-term follow-up for up to 15 years post treatment if receiving investigational T cell infusion.
You will not qualify if you...
- Medical or psychological conditions unsuitable for cell therapy, including uncontrolled malignancy or active central nervous system disease.
- Organ toxicities that may delay infusion at investigator's discretion.
- High levels of donor-specific HLA antibodies requiring desensitization without alternate donors.
- Positive for HLA-A*02:07 if eligible for TSC-101.
- Active or uncontrolled infection or viral reactivation including CMV, EBV, adenovirus, BK virus, or HHV-6.
- Active cardiac disease such as uncontrolled angina within 3 months, significant arrhythmias (except controlled atrial fibrillation), recent myocardial infarction (<3 months), or uncontrolled heart failure.
- Prior allogeneic hematopoietic cell transplantation.
- History of hypersensitivity to murine proteins.
- Enrolled in another trial with a novel investigational agent.
- Use of anti-thymocyte globulin, alemtuzumab, or other T-cell depleting agents from Day -14 through study end.
- Donors positive for any HLA-A*02 allele unless HA-1 negative for TSC-100.
- Donors positive for any HLA-A*02 allele excluded for TSC-101.
- Donors positive for HIV, HTLV, active hepatitis B or C, syphilis, West Nile virus, Creutzfeldt-Jakob disease risk, or Zika virus.
- Related donors residing outside the USA unless screening and procedures can be done at treatment site.
AI-Screening
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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
CONTACT
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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