A Study of TSC-100 and TSC-101 in AML, ALL and MDS in Patients Undergoing Allogeneic Peripheral Blood Stem Transplantation
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
1 other identifier
interventional
75
1 country
15
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2022
Typical duration for phase_1
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2022
CompletedFirst Posted
Study publicly available on registry
July 26, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
April 8, 2026
April 1, 2026
3.6 years
July 11, 2022
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Occurrence of dose limiting toxicities
Number of DLTs observed in patients compared to the control arm
two years
Occurrence of adverse events
Number of adverse events in patients compared to control arm
two years
Secondary Outcomes (9)
Comparison of disease free survival in patients versus the control arm
6 months
Comparison of disease free survival in patients versus the control arm
12 months
Disease-free survival in patients versus the control arm at 18 months, defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up.
18 months
Comparison of disease free survival in patients versus the control arm
24 months
Comparison of relapse rates between patients and control arm
6 months
- +4 more secondary outcomes
Other Outcomes (7)
Analysis of donor chimerism
60 days
Analysis of donor chimerism
100 days
Analysis of MRD
60 days
- +4 more other outcomes
Study Arms (3)
TSC-100 Treatment Arm
EXPERIMENTALHA-1 positive patients
TSC 101 Treatment Arm
EXPERIMENTALHA-1 negative and HA-2 positive patients
Standard of Care or Control arm
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
- +13 more criteria
You may not qualify if:
- Medical or psychological conditions that would make the participant an unsuitable candidate for cell therapy including another concurrent uncontrolled malignancy or active CNS disease.
- The presence of organ toxicities will not necessarily exclude participants from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA1/HA2 TCRT cells may be required at the discretion of the treating investigator
- Participants with levels of donor-specific HLA antibodies that are considered by the treating investigator to be high enough to warrant desensitization protocols and who have no alternate donors.
- Participants with evidence of clinically significant infection or uncontrolled viral r reactivation of cytomegalovirus (CMV), Epstein-Barr virus (EBV), Adenovirus, BK virus (BKV), or human herpesvirus 6 (HHV-6).
- Participants with active cardiac disease, defined as:
- Uncontrolled or symptomatic angina within the past 3 months.
- Myocardial infarction \< 3 months from study entry.
- Uncontrolled or symptomatic congestive heart failure.
- Prior allogeneic HCT.
- Participants who have a history of hypersensitivity to murine proteins.
- Enrollment on a concomitant trial with a novel investigational agent.
- Use of anti-thymocyte globulin, alemtuzumab, or other in vivo T-cell depleting agents from Day -14 through end of study.
- Donors for TSC-100 positive for any HLA-A\*02 allele would be excluded unless they are HA-1 negative. If donors with any HLA-A\*02 allele are considered for patients eligible for TSC-100, the donor would undergo HA-1 testing to ensure that the donor is HA-1 negative (40% probability).
- Donors for TSC-101 positive for any HLA-A\*02 allele are excluded regardless of HA- 2 status.
- Donors who test positive for any of the following: 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 risk of CreutzfeldtJakob disease or Zika virus infection using donor history questionnaires will also be excluded. Donors with evidence of past CMV or EBV infections will be allowed.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
City of Hope
Duarte, California, 91010, United States
Yale
New Haven, Connecticut, 06510, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
John Hopkins University
Baltimore, Maryland, 21287, United States
Mass General Hospital
Boston, Massachusetts, 02114, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Columbia University
New York, New York, 10027, United States
Mount Sinai
New York, New York, 10029-6696, United States
University North Carolina
Chapel Hill, North Carolina, 27599, United States
UPenn
Philadelphia, Pennsylvania, 19104, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
MD Anderson
Houston, Texas, 77030, United States
Froedert and Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michelle Matzko, MD
Tscan Therapeutics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2022
First Posted
July 26, 2022
Study Start
November 1, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share