Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors (advanced Cervical Cancer)

NCT ID: NCT06191900

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-05
• Study Completion Date: 2026-06-05

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GT201 treatment group

Group Type: EXPERIMENTAL

Autologous tumor infiltrating lymphocyte injection（GT201）

Intervention Type: BIOLOGICAL

GT201 treatment for advanced gynecological tumors (advanced cervical cancer)

Interventions

Autologous tumor infiltrating lymphocyte injection（GT201）

GT201 treatment for advanced gynecological tumors (advanced cervical cancer)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 1. The Patients (or legally authorized representative) 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;
• 2.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;

Exclusion Criteria

• 1.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);
• 2. Arterial/venous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
• 3.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;
• 4. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
• 5.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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grit Biotechnology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhongping Cheng, PHD

Role: CONTACT

mdcheng18@263.com

13816686812

Facility Contacts

Zhongping Cheng, PHD

Role: primary

mdcheng18@263.com

86 13816686812

Other Identifiers

GRIT-CD-CHN-201-001

Identifier Type: -

Identifier Source: org_study_id