A Phase 2 interventional study of GT101 injection and Gemcitabine injection in Adult, sponsored by Grit Biotechnology. Recruiting at 24 sites in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Grit Biotechnology · Phase 2, Interventional, and Treatment
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.
Grit Biotechnology is the lead sponsor of 30 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: GT101 injection
Drug: Gemcitabine injection
GT101 injection to treat cervical cancer
Gemcitabine injection to treat cervical cancer
Progression Free Survival
Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
Time frame: 3 years
Duration of Response
Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
Time frame: 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety will be monitored by incidence, nature, and severity of treatment-emergent adverse events, including adverse drug reactions graded according to CTCAE version 5.0.
Time frame: 3 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Grit Biotechnology