Phase
Condition
Head And Neck Cancer
Melanoma
Carcinoma
Treatment
TSC-204-A0201 + TSC-200-A0201
TSC-204-A0101
TSC-200-A0201 + TSC-204-A0101
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must be at least 18 years.
Locally advanced (unresectable) or metastatic solid tumor for which there are noavailable curative treatment options, after failure of the standard of care systemictherapies for that particular indication.
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 byTScan.
Participants must express one of the following HLA types, as assessed by a qualifiedgenomics assay in screening study TSCAN-003: HLA-B07:02, HLA-A01:01, HLA-C07:02and/or HLA-A02:01
Tumor must express one or more of the following: MAGE-A1, MAGE-A4, MAGE-C2, PRAMEand HPV16 assessed in the last 8 months in screening study TSCAN-003 (NCT05812027).
Eastern Cooperative Oncology Group (ECOG) Performance status 0-1 at screening.
Participants must be able to understand and be willing to give informed consent;decision-impaired adults may consent with their legally authorized representative.
At least 1 measurable lesion per modified Response Evaluation Criteria in SolidTumors (RECIST) v1.1.
Adequate bone marrow and organ function.
Exclusion
Exclusion Criteria:
Medical or psychological conditions that would make the participant unsuitablecandidate for cell therapy at the discretion of the PI.
History of myocardial infarction, cardiac angioplasty or stenting, unstable angina,cardiac arrhythmia requiring antiarrhythmic or procedure, or other clinicallysignificant cardiac disease within 12 months of enrollment
Have a history of ASTCT Grade 4 CRS, Grade 3 or greater ICANS, or Grade 3 or greaterIECHS. Participants with a history of lower grade CRS, ICANS, or IECHS may beeligible, pending review and approval by the Medical Monitor.
History of stroke or transient ischemic attack (TIA) within 6 months of enrollment
Systemic corticosteroid therapy >10 mg of prednisone daily or equivalent within 7days of enrollment.
History of severe hypersensitivity to fludarabine or cyclophosphamide or studyproduct excipients including human serum albumin, Cryostor (DMSO or Dextran 40), orPlasma-Lyte.
Untreated or symptomatic central nervous system (CNS) metastases or cytology provencarcinomatous meningitis.
Concurrent receipt of another anti-cancer therapy. Have a history of acute mentalstatus changes of unknown etiology within 6 months prior to enrollment, or anyneurological or neurodegenerative disorder (e.g., Parkinson disease, Huntingtondisease, uncontrolled seizure disorder) that may increase the risk for or confoundthe assessment of neurotoxicity.
Presence of fungal, bacterial, viral, or other infection requiring anti-microbialsfor management.
Tumors that have HLA LOH using a central lab clinical trial assay of HLAs addressedby the monotherapy and/or T-Plex combination TCR-Ts in the protocol and have noavailable TCR-T options for intact HLAs in the participant's tumor.
Participants who regularly require supplemental oxygen.
Study Design
Study Description
Connect with a study center
HonorHealth Research and Innovation Institute
Scottsdale, Arizona 85258
United StatesActive - Recruiting
University of California San Diego
San Diego, California 92037
United StatesActive - Recruiting
Yale Cancer Center
New Haven, Connecticut 06510
United StatesActive - Recruiting
Memorial Healthcare System
Hollywood, Florida 33021
United StatesActive - Recruiting
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United StatesActive - Recruiting
Orlando Health
Orlando, Florida 32806
United StatesActive - Recruiting
University of South Florida
Tampa, Florida 33606
United StatesActive - Recruiting
University of Chicago
Chicago, Illinois 60637
United StatesActive - Recruiting
Norton Cancer Institute
Louisville, Kentucky 40202
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York 10032
United StatesActive - Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
The Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
Providence Cancer Institute Franz Clinic
Portland, Oregon 97213
United StatesActive - Recruiting
Allegheny Hospitals Network
Pittsburgh, Pennsylvania 15224
United StatesActive - Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesActive - Recruiting
Baylor College of Medicine
Houston, Texas 77030
United StatesActive - Recruiting
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