RECRUITING

A Study of TSC-100 and TSC-101 in AML, ALL and MDS in Patients Undergoing Allogeneic Peripheral Blood Stem Transplantation

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Conditions

AMLMyelodysplastic SyndromesALL, AdultHA-1HA-2TSC-100TSC-101MDSALLAdoptive Cell TherapyT-cell receptorT lymphocyteTCR-engineered T cellsbone marrow transplanthaploidenticalallogeneic stem cell transplantBMTReduced Intensity ConditioningRICHSCTHematopoietic stem cell transplantationALLOHAMismatched unrelated donors MMUD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-11-01
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05473910

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female aged ≥ 18 years at the time of signing the informed consent.
  2. * Eastern Cooperative Oncology Group (ECOG)-PS ≤ 2 at the time of the screening visit.
  3. * Contraceptive use by male and female participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  4. * Male Participants:
  5. * 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.
  6. * Female Participants:
  7. * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  8. * Not a woman of childbearing potential (WOCBP) OR
  9. * 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.
  10. * Preparing to undergo allogeneic HCT for either of the following:
  11. * AML
  12. * MDS
  13. * ALL
  14. * Participants in the treatment arms must express HLA-A\*0201. Participants in the control arm may express any HLA type.
  15. * Having the HA1+/- or HA-1+/+ (HA-1 positive) genotype to be eligible for TSC-100 treatment.
  16. * Having the HA2+/- HA-2+/+ (HA-2 positive) genotype to be eligible for TSC-101 treatment.
  17. * Having a haploidentical donor, MMUD, or MUD for HCT who is adequately HLA-matched by institutional standards and meets the donor inclusion criteria.
  18. * Considered to be clinically indicated for haploidentical donor, MMUD, or MUD transplantation at the discretion of the treating investigator.
  19. * Considered to be clinically indicated for RIC at the discretion of the treating investigator.
  20. * Considered to be clinically indicated for peripheral blood stem cell transplantation at the discretion of the treating investigator.
  21. * Organ function parameters for transplant eligibility are met per institutional standards.
  22. * Capable of giving signed informed consent - which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  23. * Participants must provide consent for mandatory study procedures including bone marrow biopsy and blood sampling for research analyses in the ICF.
  24. * Participants must agree to participate in long-term follow-up for up to 15 years post initial product treatment if they are enrolled in the study and receive the investigational Tcell infusion.
  25. * Male or female aged ≥ 18 years at the time of signing the informed consent.
  26. * Able to undergo peripheral blood stem cell (PBSC) collection and up to 2 rounds of leukapheresis (for TSC-100 or TSC101 manufacturing for treatment arms only, and f for stem cell collection for both treatment arms and the control arm).
  27. * Donors matched to TSC-100 participants should be HA-1-/- (negative) and/or negative for all HLA-A\*02 alleles
  28. * Donors matched to TSC-101 participants should be negative for all HLA-A\*02 alleles
  29. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  1. * Medical or psychological conditions that would make the participant an unsuitable candidate for cell therapy including another concurrent uncontrolled malignancy or active CNS disease.
  2. * 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
  3. * 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.
  4. * Participants who meet inclusion criteria for TSC-101 but who are also positive for HLAA\*02:07.
  5. * 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).
  6. * Participants with active cardiac disease, defined as:
  7. * Uncontrolled or symptomatic angina within the past 3 months.
  8. * History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes). Atrial fibrillation with controlled ventricular response on treatment is not an exclusion.
  9. * Myocardial infarction \< 3 months from study entry.
  10. * Uncontrolled or symptomatic congestive heart failure.
  11. * Prior allogeneic HCT.
  12. * Participants who have a history of hypersensitivity to murine proteins.
  13. * Enrollment on a concomitant trial with a novel investigational agent.
  14. * Use of anti-thymocyte globulin, alemtuzumab, or other in vivo T-cell depleting agents from Day -14 through end of study.
  15. * 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).
  16. * Donors for TSC-101 positive for any HLA-A\*02 allele are excluded regardless of HA- 2 status.
  17. * 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.
  18. * 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.

Contacts and Locations

Study Contact

Jim Murray
CONTACT
8573999500
medicalaffairs@tscan.com

Principal Investigator

Michelle Matzko, MD
STUDY_DIRECTOR
Tscan Therapeutics

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: TScan Therapeutics, Inc.

  • Michelle Matzko, MD, STUDY_DIRECTOR, Tscan Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01
Study Completion Date2026-06

Study Record Updates

Study Start Date2022-11-01
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • AML
  • Myelodysplastic Syndromes
  • ALL, Adult