MAGE-A4-directed TCR-T in the Treatment Amongst Subjects With Advanced Solid Tumors
Trial Parameters
Brief Summary
A single-arm, open-label, dose exploratory study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-MAGE-A4 T cell receptor-engineered T cell (TCR-T) in advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. 18-75 year-old, male or female 2. Voluntarily willing to participate in the study and sign the written informed consent form 3. Life expectation ≥12 weeks 4. European Cooperative Oncology Group (ECOG) ≤1 at screening, 24 hours prior to apheresis (APH), lymphodepletion (LD), and infusion 5. Histologically-confirmed recurrent/metastatic advanced solid tumors 6. Radiologically-confirmed progression disease after at least one prior line of systematic treatment and no available standard of care at screening, judged by investigators 7. Fresh or formalin-fixed paraffin-embedded (FFPE) samples, immunohistochemistry (IHC)-stained MAGE-A4 positive 8. Human leukocyte antigen (HLA)-A\*02 allele matched 9. Per response evaluation criteria in solid tumors (RECIST) version 1.1, at least one measurable lesion 10. Adequate organ functions 11. Adequate venous access for APH 12. Non-hematological adverse events induced by previous treatment must have recovered to Grade ≤1 according