Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors

Grit Biotechnology

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Solid Tumor

Treatments

Biological: GT201

Study type

Interventional

Funder types

Industry

Identifiers

NCT05729399

GRIT-CD-MED-CHN-001

Details and patient eligibility

About

This study is a multi-center, single-arm phase I clinical trial. A total of 26~42 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study.

An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period

Enrollment

42 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1.Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.

2.At least one lesion (preferably superficial lymph nodes) that has not been treated with radiation, has not received other local therapies, has access to tumor tissue, and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion source or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes.

3.Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.

Exclusion criteria

1.Failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment.

2.People with uncontrolled tumor-related pain as judged by the investigator. 3.Risk of major bleeding as assessed by investigators. 4.Have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function.

5.Any active autoimmune disease 14 days prior to clear lymphatic chemotherapy, history of autoimmune disease, or disease requiring systemic steroid hormone or immunosuppressive drug therapy .

6.History of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin)); 7.Women who are pregnant or breastfeeding;