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

Adult Clinical Trial

Official title:

Single Arm Clinical Study of Autologous Tumor Infiltrating Lymphocyte Injection (GT201) in the Treatment of Advanced Gynecological Tumors (Advanced Cervical Cancer)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06191900
• Other study ID #: GRIT-CD-CHN-201-001
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2023
• Est. completion date: June 5, 2026

Study information

• Verified date: December 2023
• Source: Grit Biotechnology
• Contact: Zhongping Cheng, PHD
• Phone: 13816686812
• Email: mdcheng18[@]263.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: June 5, 2026
• Est. primary completion date: June 5, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
• 3.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. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
• 2.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);
• 3. Arterial/venous thrombotic events within 3 months prior to enrollment, such as:

cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;

• 4.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;
• 5. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
• 6.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);

Related Conditions & MeSH terms

• Adult
• Gynecological Tumors
• Uterine Cervical Neoplasms

Intervention

Biological:
• Autologous tumor infiltrating lymphocyte injection(GT201)
GT201 treatment for advanced gynecological tumors (advanced cervical cancer)

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Grit Biotechnology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Profile Measured by Grade =3 TRAEs	Safety Profile Measured by Grade =3 TRAEs by CTCAE 5.0	3 years