TerminatedPhase 1/2

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

Stopped: The study was terminated from a business perspective.

China6 participantsStarted 2022-09-14

Plain-language summary

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

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕.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.
✕.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 .
✕.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;

What they're measuring

Incidence and severity of adcersed events per CTCAE 5.0

Timeframe: 3 years

Trial details

NCT IDNCT05729399

SponsorGrit Biotechnology

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-30

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