Status:
RECRUITING
Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/recurrent Advanced Solid Tumors
Lead Sponsor:
Grit Biotechnology
Conditions:
Solid Tumor
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This study is a single-center, single-arm phase I clinical trial. A total of 30 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study. An "autologous tumor-infiltrat...
Eligibility Criteria
Inclusion
- Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol
- 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
- Failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment
- People with uncontrolled tumor-related pain as judged by the investigator
- Risk of major bleeding as assessed by investigators
- 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 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; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year of the cell return.
Key Trial Info
Start Date :
January 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05430360
Start Date
January 4 2022
End Date
May 1 2025
Last Update
February 17 2025
Active Locations (1)
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1
The First Hospital of Zhejiang University
Hangzhou, Zhejiang, China