ACTIVE_NOT_RECRUITING

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

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

TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived engeneered 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.

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

Quick Facts

Study Start:2024-05-06
Study Completion:2026-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05973487

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:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Must be at least 18 years.
  2. 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. 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. 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 and/or HLA-A\*02:01
  5. 5. Tumor must express one or more of the following: MAGE-A1, MAGE-A4, MAGE-C2, PRAME and HPV16 assessed in the last 8 months in screening study TSCAN-003 (NCT05812027).
  6. 6. Eastern Cooperative Oncology Group (ECOG) Performance status 0-1 at screening.
  7. 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. 8. At least 1 measurable lesion per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  9. 9. Adequate bone marrow and organ function.
  1. 1. Medical or psychological conditions that would make the participant unsuitable candidate for cell therapy at the discretion of the PI.
  2. 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. 3. Have a history of ASTCT Grade 4 CRS, Grade 3 or greater ICANS, or Grade 3 or greater IECHS. Participants with a history of lower grade CRS, ICANS, or IECHS may be eligible, pending review and approval by the Medical Monitor.
  4. 4. History of stroke or transient ischemic attack (TIA) within 6 months of enrollment
  5. 5. Systemic corticosteroid therapy \>10 mg of prednisone daily or equivalent within 7 days of enrollment.
  6. 6. History of severe hypersensitivity to fludarabine or cyclophosphamide or study product excipients including human serum albumin, Cryostor (DMSO or Dextran 40), or Plasma-Lyte.
  7. 7. Untreated or symptomatic central nervous system (CNS) metastases or cytology proven carcinomatous meningitis.
  8. 8. Concurrent receipt of another anti-cancer therapy. Have a history of acute mental status changes of unknown etiology within 6 months prior to enrollment, or any neurological or neurodegenerative disorder (e.g., Parkinson disease, Huntington disease, uncontrolled seizure disorder) that may increase the risk for or confound the assessment of neurotoxicity.
  9. 9. Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for management.
  10. 10. 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.
  11. 11. Participants who regularly require supplemental oxygen.

Contacts and Locations

Principal Investigator

Dawn Pinchasik, MD
STUDY_DIRECTOR
TScan Therapeutics

Study Locations (Sites)

HonorHealth Research and Innovation Institute
Scottsdale, Arizona, 85258
United States
University of California San Diego
San Diego, California, 92037
United States
Yale Cancer Center
New Haven, Connecticut, 06510
United States
Memorial Healthcare System
Hollywood, Florida, 33021
United States
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
Orlando Health
Orlando, Florida, 32806
United States
University of South Florida
Tampa, Florida, 33606
United States
University of Chicago
Chicago, Illinois, 60637
United States
Norton Cancer Institute
Louisville, Kentucky, 40202
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455
United States
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Oncology Hematology Care
Cincinnati, Ohio, 45242
United States
The Cleveland Clinic
Cleveland, Ohio, 44195
United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
United States
Allegheny Hospitals Network
Pittsburgh, Pennsylvania, 15224
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: TScan Therapeutics, Inc.

  • Dawn Pinchasik, 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 Date2024-05-06
Study Completion Date2026-12-30

Study Record Updates

Study Start Date2024-05-06
Study Completion Date2026-12-30

Terms related to this study

Keywords Provided by Researchers

  • HPV16 E7
  • MAGE-A1
  • TCR-T Therapy
  • Cell Therapy
  • Immunotherapy
  • TScan Therapeutics
  • TSCAN-002
  • TSCAN-003
  • PRAME
  • MAGE-C2
  • MAGE-A4

Additional Relevant MeSH Terms

  • 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