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

NCT05473910 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: TSCAN-001 (Phase 1)
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 21

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

Conditions

AML; MDS

Keywords

HA-2; TSC-101; AML; MDS; Adoptive Cell Therapy; T-cell receptor; T lymphocyte; TCR-engineered T cells; bone marrow transplant; haploidentical; allogeneic stem cell transplant; BMT; RIC; HSCT; Hematopoietic stem cell transplantation; ALLOHA-2; Mismatched unrelated donors MMUD; ALLOHA; HA-1; TSC-100; ALL; Reduced Intensity Conditioning

Outcome Measures

Primary Outcomes (2)

• Occurrence of dose limiting toxicities

  Number of DLTs observed in patients compared to the control arm

  2 years

• Occurrence of adverse events

  Number of adverse events in patients compared to control arm

  2 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

Other Outcomes (7)

• Analysis of donor chimerism

  60 days

• Analysis of donor chimerism

  100 days

• Analysis of MRD

  60 days

Study Arms (3)

Treatment Arm (TSC-100)

EXPERIMENTAL

HA-1 positive patients

Drug: SOC + TSC-100

Treatment Arm (TSC-101)

EXPERIMENTAL

HA-1 negative and HA-2 positive patients

Drug: SOC + TSC-101

Control Arm (Standard of Care)

ACTIVE COMPARATOR

Other: Control SOC alone

Other: Control

Interventions

SOC + TSC-100 DRUG

HA-1 positive

Treatment Arm (TSC-100)

SOC + TSC-101 DRUG

HA-2 positive or HA-1 negative

Treatment Arm (TSC-101)

Control OTHER

SOC alone

Control Arm (Standard of Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• Having the HA2+/- HA-2+/+ (HA-2 positive) genotype to be eligible for TSC-101 treatment.
• Considered to be clinically indicated for haploidentical donor, MMUD, or MUD transplantation at the discretion of the treating investigator.

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:
• 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.
• Related donor residing outside of the United States of America (USA). If the donor screening, testing and leukapheresis can be performed at the same site where the participant is being treated, the donor is considered eligible.

Sponsors & Collaborators

• TScan Therapeutics, Inc.: lead

Study Sites (21)

City of Hope

Duarte, California, 91010, United States

RECRUITING

University of Colorado - Anschutz Cancer Center

Aurora, Colorado, 80045, United States

RECRUITING

SCRI - Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

RECRUITING

Yale

New Haven, Connecticut, 06510, United States

RECRUITING

Memorial Cancer Institute

Hollywood, Florida, 33021, United States

RECRUITING

Moffitt Cancer Institute

Tampa, Florida, 33612, United States

RECRUITING

Northside Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Mass General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana-Farber Cancer Institute - Hematology/Oncology

Boston, Massachusetts, 02215, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Columbia University

New York, New York, 10027, United States

RECRUITING

Mount Sinai

New York, New York, 10029-6696, United States

RECRUITING

University North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

SCRI - TriStar Bone Marrow Transplant

Nashville, Tennessee, 37203, United States

RECRUITING

St. David's South Austin Medical Center

Austin, Texas, 76704, United States

RECRUITING

Baylor University Medical Center

Dallas, Texas, 75246, United States

RECRUITING

MD Anderson

Houston, Texas, 77030, United States

RECRUITING

Froedert and Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Study Officials

• Shrikanta Chattopadhyay, MD

  Tscan Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Tim White

CONTACT

(857) 399-9500; medicalaffairs@tscan.com

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: June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)