Phase
Condition
Nasopharyngeal Cancer
Pelvic Cancer
Head And Neck Cancer
Treatment
TSC-204-C0702 + TSC-202-A0201
TSC-203-A0201
TSC-200-A0201 + TSC-202-A0201
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 StatesSite Not Available
HonorHealth Research and Innovation Institute
Scottsdale 5313457, Arizona 5551752 85258
United StatesSite Not Available
University of California San Diego
San Diego, California 92037
United StatesSite Not Available
University of California San Diego
San Diego 5391811, California 5332921 92037
United StatesSite Not Available
Yale Cancer Center
New Haven, Connecticut 06510
United StatesSite Not Available
Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06510
United StatesSite Not Available
Memorial Healthcare System
Hollywood, Florida 33021
United StatesSite Not Available
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United StatesSite Not Available
Orlando Health
Orlando, Florida 32806
United StatesSite Not Available
University of South Florida
Tampa, Florida 33606
United StatesSite Not Available
Memorial Healthcare System
Hollywood 4158928, Florida 4155751 33021
United StatesSite Not Available
University of Miami, Sylvester Comprehensive Cancer Center
Miami 4164138, Florida 4155751 33136
United StatesSite Not Available
Orlando Health
Orlando 4167147, Florida 4155751 32806
United StatesSite Not Available
University of South Florida
Tampa 4174757, Florida 4155751 33606
United StatesSite Not Available
University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
University of Chicago
Chicago 4887398, Illinois 4896861 60637
United StatesSite Not Available
Norton Cancer Institute
Louisville, Kentucky 40202
United StatesSite Not Available
Norton Cancer Institute
Louisville 4299276, Kentucky 6254925 40202
United StatesSite Not Available
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
United StatesSite Not Available
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota 55455
United StatesSite Not Available
University of Minnesota Masonic Cancer Center
Minneapolis 5037649, Minnesota 5037779 55455
United StatesSite Not Available
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York 10032
United StatesSite Not Available
Columbia University Herbert Irving Comprehensive Cancer Center
New York 5128581, New York 5128638 10032
United StatesSite Not Available
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United StatesSite Not Available
University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesSite Not Available
The Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Oncology Hematology Care
Cincinnati 4508722, Ohio 5165418 45242
United StatesSite Not Available
The Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
OU Health Stephenson Cancer Center
Oklahoma City 4544349, Oklahoma 4544379 73104
United StatesSite Not Available
Providence Cancer Institute Franz Clinic
Portland, Oregon 97213
United StatesSite Not Available
Providence Cancer Institute Franz Clinic
Portland 5746545, Oregon 5744337 97213
United StatesSite Not Available
Allegheny Hospitals Network
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
Allegheny Hospitals Network
Pittsburgh 5206379, Pennsylvania 6254927 15224
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh 5206379, Pennsylvania 6254927 15232
United StatesSite Not Available
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesSite Not Available
Sarah Cannon Research Institute
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
Baylor College of Medicine
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available

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