Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors

NCT06834542 | Terminated Early Phase 1

• 1 other identifier: GRIT-CD-MED-CHN-002
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an early exploration clinical study with one arm. The study consists of two stages, namely the dose escalation stage and the dose extension stage:

Conditions

Adult Gynecological Tumors

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate

  To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator

  3 years

• Incidence and severity of adcersed events per CTCAE 5.0

  To characterize the safety profile of autologous TIL injection（GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0

  3 years

• Progression-Free Survival

  To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator

  3 years

Study Arms (1)

GT307 injection treatment group

EXPERIMENTAL

Biological: Autologous tumor infiltrating lymphocyte injection（GT201）

Interventions

Autologous tumor infiltrating lymphocyte injection（GT201） BIOLOGICAL

GT201 treatment for advanced gynecological tumors (advanced cervical cancer)

GT307 injection treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
• The physical fitness status score of the ECOG is 0 or 1
• At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass weighing ≥1.0g (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;

You may not qualify if:

• The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\>10 mg/day of prednisone or equivalent hormone);
• Arterial/venous thrombotic events within 6 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
• Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃ occurring during the screening period, except for tumor fever;
• Patients who have received allogeneic bone marrow transplantation or an organ allograft;
• Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin)

Sponsors & Collaborators

• Grit Biotechnology: lead

Study Sites (1)

Shanghai Jiaotong University School of Medcine, Renji Hospital Ethica Committee

Shanghai, Shanghai Municipality, China

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 19, 2025
• Study Start: November 1, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

CN (1)