Tests GT101 cell therapy against gemcitabine in recurrent or metastatic cervical cancer

Trial details

Who runs it

Grit Biotechnology

Trial code

NCT06241781

Record updated

9 November 2026

Original description

This is a Phase II, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in participants with recurrent or metastatic cervical cancer.Read full original descriptionShow less

A Phase 2, Multicenter Randomized Controlled Open-label Study of Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer

This is a Phase II, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in participants with recurrent or metastatic cervical cancer.

Inclusion: 1. Voluntarily enroll in the study, sign the informed consent form, and be willing and able to comply with the study protocol; 2. Aged ≥18 years and ≤70 years; 3. Recurrent or metastatic cervical cancer: have received prior adequate first-line systemic therapy with radiologically confirmed disease progression during or after treatment; 4. Have at least one resectable tumor lesion for the manufacture of autologous tumor-infiltrating lymphocytes (TILs); 5. Apart from the sampling lesion(s), have at least one measurable lesion per RECIST 1.1; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7. Expected survival ≥12 weeks; 8. Adequate normal organ and bone marrow function; 9. Serum human chorionic gonadotropin (HCG) test must be negative within 7 days prior to TIL infusion for women of childbearing potential without surgical sterilization; 10. Adverse events from prior therapies must have recovered to Grade ≤1 (per CTCAE 5.0) before tumor sampling; 11. Participants entering this study due to disease progression must have radiological documentation of disease progression following the last prior treatment before tumor resection.

Exclusion: 1. Spinal cord compression not relieved by surgery and/or radiotherapy is exclusionary; 3. Bleeding events occurring within 3 months prior to screening; 4. Arterial or venous thromboembolic events within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis (DVT), pulmonary embolism (PE), etc; 11. Infectious diseases within 1 year prior to screening; 12. Use of anti-angiogenic agents within 4 weeks before sampling; 13. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 14. Systemic anti-tumor therapy administered within 4 weeks prior to lymphodepleting chemotherapy; 15. Prior receipt of genetically modified or edited cellular therapy products; 16. History of allergic reaction to any component of the investigational agents to be used in this study; 18. Prior immunotherapy associated with Grade ≥3 immune-related adverse events (irAEs) that failed to recover to CTCAE Grade 1 or lower within 28 days; 20. Receipt of other investigational medicinal products within 4 weeks prior to randomization, or plan to receive other investigational medicinal products during the study; 5. Respiratory diseases that substantially impair pulmonary function; 6. History of clinically significant cardiovascular disease; 8. Active autoimmune disease requiring systemic corticosteroids or immunosuppressive therapy; 9. Malignancies other than the target indication diagnosed within 5 years before screening; 10. Refractory/intractable epilepsy, medically uncontrolled pleural effusion, etc; 17. Known psychiatric disorders, alcohol abuse, illicit drug use, or substance abuse; 21. Other conditions judged unsuitable for enrollment by the investigator; 2. Uncontrolled tumor-related pain as judged by the investigator; 7. Participants with untreated central nervous system (CNS) metastatic lesions at screening; 19. Pregnant or lactating women, or women planning pregnancy, gestation or lactation within 1 year after cell infusion.

ClinicalTrials.gov NCT06241781