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A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05973487
Recruitment Status : Recruiting
First Posted : August 3, 2023
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
TScan Therapeutics, Inc.

Study Description
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Brief Summary:

TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived T cells are engineered to express a T cell receptor that recognizes cancer-associated antigens presented on specific Human Leukocyte Antigen (HLA) molecules.

This is a multi-center, non-randomized, multi-arm, open-label, basket study evaluating the safety and preliminary efficacy of single and repeat dose regimens of TCR'Ts as monotherapies and as T-Plex combinations after lymphodepleting chemotherapy in participants with locally advanced, metastatic solid tumors disease.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Cervical Cancer Non-small Cell Carcinoma Melanoma Ovarian Cancer Anogenital Cancers HPV - Anogenital Human Papilloma Virus Infection HPV-Related Cervical Carcinoma HPV-Related Carcinoma HPV-Related Squamous Cell Carcinoma HPV-Related Malignancy HPV-Related Adenocarcinoma HPV Positive Oropharyngeal Squamous Cell Carcinoma HPV-Related Adenosquamous Carcinoma HPV-Associated Vaginal Adenocarcinoma HPV-Related Endocervical Adenocarcinoma HPV-Related Anal Squamous Cell Carcinoma HPV-Related Verrucous Carcinoma HPV-Related Penile Squamous Cell Carcinoma HPV-Related Vulvar Squamous Cell Carcinoma HPV Positive Rectal Squamous Cell Carcinoma Biological: TSC-204-A0201 Biological: TSC-204-C0702 Biological: TSC-200-A0201 Biological: TSC-204-A0201 + TSC-204-C0702 Biological: TSC-204-A0201 + TSC-200-A0201 Biological: TSC-204-C0702 + TSC-200-A0201 Biological: TSC-204-A0201 + TSC-203-A0201 Biological: TSC-204-C0702 + TSC-203-A0201 Biological: TSC-200-A0201 + TSC-203-A0201 Biological: TSC-203-A0201 Biological: TSC-204-A0101 Biological: TSC-201-B0702 Biological: TSC-204-A0201 + TSC-204-A0101 Biological: TSC-204-A0201 + TSC-201-B0702 Biological: TSC-204-C0702 + TSC-204-A0101 Biological: TSC-204-C0702 + TSC-201-B0702 Biological: TSC-200-A0201 + TSC-204-A0101 Biological: TSC-200-A0201 + TSC-201-B0702 Biological: TSC-203-A0201 + TSC-204-A0101 Biological: TSC-203-A0201 + TSC-201-B0702 Phase 1

Detailed Description:

Participants will be screened in a separate screening study, TSCAN-003 (NCT05812027), to assess their HLA type, tumor-associated antigen (TAA) expression and loss of heterozygosity (LOH) status. The results of these tests will be used to determine initial eligibility in this study.

Depending on the genetic type, participants will be assigned to one of the following study groups:

Monotherapy:

  • COHORT A: TSC-204-A0201 targeting MAGE-A1 on HLA-A*02:01
  • COHORT B: TSC-204-C0702 targeting MAGE-A1 on HLA-C*07:02
  • COHORT C: TSC-200-A0201 targeting HPV16 E7 on HLA-A*02:01
  • COHORT D: TSC-203-A0201 targeting PRAME on HLA-A*02:01
  • COHORT E: TSC-204-A0101 targeting MAGE-A1 on HLA-A*01:01
  • COHORT F: TSC-201-B0702 targeting MAGE-C2 on HLA-B*07:02

T-Plex Combination:

  • COHORT AB: TSC-204-A0201 + TSC-204-C0702
  • COHORT AC: TSC-204-A0201 + TSC-200-A0201
  • COHORT AD: TSC-204-A0201 + TSC-203-A0201
  • COHORT AE: TSC-204-A0201 + TSC-204-A0101
  • COHORT AF: TSC-204-A0201 + TSC-201-B0702
  • COHORT BC: TSC-204-C0702 + TSC-200-A0201
  • COHORT BD: TSC-204-C0702 + TSC-203-A0201
  • COHORT BE: TSC-204-C0702 + TSC-204-A0101
  • COHORT BF: TSC-204-C0702 + TSC-201-B0702
  • COHORT CD: TSC-200-A0201 + TSC-203-A0201
  • COHORT CE: TSC-200-A0201 + TSC-204-A0101
  • COHORT CF: TSC-200-A0201 + TSC-201-B0702
  • COHORT DE: TSC-203-A0201 + TSC-204-A0101
  • COHORT DF: TSC-203-A0201 + TSC-201-B0702
  • COHORT EF: TSC-204-A0101 + TSC-201-B0702

Participants will undergo leukapheresis to collect cells to manufacture the TCR-T products. They will then undergo lymphodepletion and receive one or two doses of the TCR-T cell therapy product as a monotherapy or part of a combination of TCR-Ts (referred to as T-Plex combinations in this study).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants With Antigen-positive Locally Advanced (Unresectable) or Metastatic Solid Tumors
Estimated Study Start Date : April 30, 2024
Estimated Primary Completion Date : December 30, 2026
Estimated Study Completion Date : December 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Monotherapy Cohort A
TSC-204-A0201
 Biological: TSC-204-A0201
Escalating doses of TSC-204-A0201 as a monotherapy
Experimental: Monotherapy Cohort B
TSC-204-C0702
 Biological: TSC-204-C0702
Escalating doses of TSC-204-C0702 as a monotherapy
Experimental: Monotherapy Cohort C
TSC-200-A0201
 Biological: TSC-200-A0201
Escalating doses of TSC-200-A0201 as a monotherapy
Experimental: T-Plex Combination Cohort A + B
TSC-204-A0201 and TSC-204-C0702
 Biological: TSC-204-A0201 + TSC-204-C0702
Escalating doses of TSC-204-A0201 in combination with TSC-204-C0702
Experimental: T-Plex Combination Cohort B + C
TSC-204-C0702 and TSC-200-A0201
 Biological: TSC-204-A0201 + TSC-200-A0201
Escalating doses of TSC-204-A0201 in combination with TSC-200-A0201
Experimental: T-Plex Combination Cohort A + C
TSC-204-A0201 and TSC-200-A0201
 Biological: TSC-204-C0702 + TSC-200-A0201
Escalating doses of TSC-204-C0702 in combination with TSC-200-A0201
Experimental: Monotherapy Cohort D
TSC-203-A0201
 Biological: TSC-203-A0201
Escalating doses of TSC-203-A0201 as a monotherapy
Experimental: T-Plex Combination Cohort A + D
TSC-204-A0201 + TSC-203-A0201
 Biological: TSC-204-A0201 + TSC-203-A0201
Escalating doses of TSC-204-A0201 in combination with TSC-203-A0201
Experimental: T-Plex Combination Cohort B + D
TSC-204-C0702 + TSC-203-A0201
 Biological: TSC-204-C0702 + TSC-203-A0201
Escalating doses of TSC-204-C0702 in combination with TSC-203-A0201
Experimental: Monotherapy Cohort E
TSC-204-A0101
 Biological: TSC-204-A0101
Escalating doses of TSC-204-A0101 as a monotherapy
Experimental: Monotherapy Cohort F
TSC-201-B0702
 Biological: TSC-201-B0702
Escalating doses of TSC-201-B0702 as a monotherapy
Experimental: T-Plex Combination Cohort A + E
TSC-204-A0201 + TSC-204-A0101
 Biological: TSC-204-A0201 + TSC-204-A0101
Escalating doses of TSC-204-A0201 in combination with TSC-204-A0101
Experimental: T-Plex Combination Cohort A + F
TSC-204-A0201 + TSC-201-B0702
 Biological: TSC-204-A0201 + TSC-201-B0702
Escalating doses of TSC-204-A0201 in combination with TSC-201-B0702
Experimental: T-Plex Combination Cohort B + E
TSC-204-C0702 + TSC-204-A0101
 Biological: TSC-204-C0702 + TSC-204-A0101
Escalating doses of TSC-204-C0702 in combination with TSC-204-A0101
Experimental: T-Plex Combination Cohort B + F
TSC-204-C0702 + TSC-201B0702
 Biological: TSC-204-C0702 + TSC-201-B0702
Escalating doses of TSC-204-C0702 in combination with TSC-201-B0702
Experimental: T-Plex Combination Cohort C + D
TSC-200-A0201 + TSC-203-A0201
 Biological: TSC-200-A0201 + TSC-203-A0201
Escalating doses of TSC-200-A0201 in combination with TSC-203-A0201
Experimental: T-Plex Combination Cohort C + E
TSC-200-A0201 + TSC-204-A0101
 Biological: TSC-200-A0201 + TSC-204-A0101
Escalating doses of TSC-200-A0201 in combination with TSC-204-A0101
Experimental: T-Plex Combination Cohort C + F
TSC-200-A0201 + TSC-201B0702
 Biological: TSC-200-A0201 + TSC-201-B0702
Escalating doses of TSC-200-A0201 in combination with TSC-201-B0702
Experimental: T-Plex Combination Cohort D + E
TSC-203-A0201 + TSC-204A0101
 Biological: TSC-203-A0201 + TSC-204-A0101
Escalating doses of TSC-203-A0201 in combination with TSC-204-A0101
Experimental: T-Plex Combination Cohort D + F
TSC-203-A0201 + TSC-201B0702
 Biological: TSC-203-A0201 + TSC-201-B0702
Escalating doses of TSC-203-A0201 in combination with TSC-201-B0702
Experimental: T-Plex Combination Cohort E + F
TSC-204-A0101 + TSC-201-B0702
 Biological: TSC-204-A0101
Escalating doses of TSC-204-A0101 as a monotherapy

Biological: TSC-201-B0702
Escalating doses of TSC-201-B0702 as a monotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the safety of monotherapy and T- Plex combination TCR-Ts [ Time Frame: 28 days ]
    Number of subjects with dose limiting toxicities (DLT)

  2. Determine the recommended phase 2 dose of monotherapy and T- Plex combination TCR-Ts [ Time Frame: Up to 12 months ]
    Frequency and severity of DLTs, AEs and SAEs


Secondary Outcome Measures :
  1. Investigate preliminary anti-tumor activity of monotherapy and T- Plex combination TCR-Ts [ Time Frame: Up to 12 months ]
    Response Evaluation Criteria In Solid Tumors RECIST 1.1

  2. Investigate the feasibility of repeat dosing of monotherapy and T- Plex combination TCR-Ts [ Time Frame: Up to 12 months ]
    Frequency and severity of DLTs, AEs and SAEs


Other Outcome Measures:
  1. To measure the persistence of T-Plex TCR-T cells in the peripheral blood with single and repeat doses [ Time Frame: Up to 24 months ]
    Percentage of TCR-T cells in the peripheral blood after single and repeat doses

  2. To measure the infiltration of T-Plex TCR-T cells into tumors in post-treatment biopsies [ Time Frame: Up to 24 months ]
    Percentage of TCR-T cells in the tumor after single and repeat doses

  3. To measure the immune activation markers in the tumor after single and repeated doses [ Time Frame: Up to 24 months ]
    Status of immune activation markers in the tumor after single and repeat doses


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be at least 18 years.
  2. Locally advanced (unresectable) or metastatic solid tumor for which there are no available curative treatment options, after failure of the standard of care systemic therapies for that particular indication.
  3. Solid tumors, including but not limited to non-nasopharyngeal head and neck cancer, non-small cell lung cancer, cutaneous melanoma, cervical cancer, ovarian cancer, anal cancer and genital cancers. Other tumor types may be permitted if approved by TScan.

  4. Participants must express one of the following HLA types, as assessed by a qualified genomics assay in screening study TSCAN-003:

    HLA-B*07:02 HLA-A*01:01 HLA-C*07:02 HLA-A*02:01

  5. Tumor must express one or more of the following: MAGE-A1, MAGE-C2, PRAME and HPV16-E7 assessed in the last 8 months in screening study TSCAN-003 (NCT05812027).
  6. Eastern Cooperative Oncology Group (ECOG) Performance status 0-1 at screening.
  7. Participants must be able to understand and be willing to give informed consent; decision-impaired adults may consent with their legally authorized representative.
  8. At least 1 measurable lesion per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  9. Adequate bone marrow and organ function.

Exclusion Criteria:

  1. Medical or psychological conditions that would make the participant unsuitable candidate for cell therapy at the discretion of the PI.
  2. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, cardiac arrhythmia requiring antiarrhythmic or procedure, or other clinically significant cardiac disease within 12 months of enrollment
  3. History of stroke or transient ischemic attack (TIA) within 12 months of enrollment
  4. Systemic corticosteroid therapy >10 mg of prednisone daily or equivalent within 7 days of enrollment
  5. History of severe hypersensitivity to fludarabine or cyclophosphamide or study product excipients including human serum albumin, Cryostor (DMSO or Dextran 40), or Plasma-Lyte.
  6. Untreated or symptomatic central nervous system (CNS) metastases or cytology proven carcinomatous meningitis.
  7. Concurrent receipt of another anti-cancer therapy.
  8. Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for management.
  9. Tumors that have HLA LOH using a central lab clinical trial assay of HLAs addressed by the monotherapy and/or T-Plex combination TCR-Ts in the protocol and have no available TCR-T options for intact HLAs in the participant's tumor.
  10. Participants who regularly require supplemental oxygen.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05973487


Contacts
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Contact: Marlyane Motta, BS 857-399-9887 mmotta@tscan.com
Contact: OncoBay Clinical CRO 843-321-8490 oncobaysites@oncobay.com

Locations
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United States, Arizona
HonorHealth Research and Innovation Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Justin Moser, MD    480-323-1364    clinicaltrials@honorhealth.com   
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06510
Contact: Jialing Zhang    475-234-9684    Jialing.zhang@yale.edu   
Principal Investigator: Michael Hurwitz, MD         
United States, Florida
Memorial Healthcare System Recruiting
Hollywood, Florida, United States, 33021
Contact: Brian Pico, MD    954-265-1847    bpico@mhs.net   
University of Miami, Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Marialby Donis Ramos    305-243-1000    mxd4514@med.miami.edu   
Principal Investigator: Jose Lutzky, MD         
Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Melinda Porter    321-841-7246    janice.porter@orlandohealth.com   
Principal Investigator: Sajeve Thomas, MD         
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact: Ben Orem    502-629-2500 ext 19471    ben.orem@nortonhealthcare.org   
Principal Investigator: Jaspreet Grewal, MD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Marie Ventimiglia    313-576-9271    ventimim@karmanos.org   
Principal Investigator: Ira Winer, MD         
United States, Minnesota
University of Minnesota Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Manar Al-Assi       malassi@umn.edu   
United States, New York
Columbia University Herbert Irving Comprehensive Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Elizabeth Shelton, MPH    212-342-0248    cancerclinicaltrials@cumc.columbia.edu   
Principal Investigator: Brian Henick, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: UNC Immunotherapy Team    919-445-4208    UNCImmunotherapy@med.unc.edu   
Principal Investigator: Jared Weiss, MD         
United States, Ohio
The Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Cancer Answer Line    216-444-7923      
Principal Investigator: James Isaacs, MD         
United States, Oregon
Providence Cancer Institute Franz Clinic Recruiting
Portland, Oregon, United States, 97213
Contact: Rom Leidner, MD    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Rom Leidner, MD         
United States, Pennsylvania
Allegheny Hospitals Network Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Shelly Evans       shelly.evans@ahn.org   
Principal Investigator: Yazan Samhouri, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Barb Stadterman       stadtermanbm@upmc.edu   
Principal Investigator: Jason Luke, MD         
Sponsors and Collaborators
TScan Therapeutics, Inc.
Investigators
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Study Director: Dawn Pinchasik, MD TScan Therapeutics
More Information
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Responsible Party: TScan Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05973487    
Other Study ID Numbers: TSCAN-002
First Posted: August 3, 2023    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TScan Therapeutics, Inc.:
HPV16 E7
MAGE-A1
TSC-204-A0201
TSC-204-C0702
TSC-200-A0201
TCR-T Therapy
 Cell Therapy
Immunotherapy
TScan Therapeutics
TSCAN-002
TSCAN-003
PRAME
Additional relevant MeSH terms:
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Papillomavirus Infections
Carcinoma
Carcinoma, Squamous Cell
Adenocarcinoma
Carcinoma, Verrucous
Papilloma
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Neoplasms, Squamous Cell
Urogenital Diseases
Genital Diseases
 Head and Neck Neoplasms
Virus Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Communicable Diseases
DNA Virus Infections
Tumor Virus Infections
Disease Attributes
Pathologic Processes
Neoplasms, Complex and Mixed
Trans-sodium crocetinate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents