Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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.
