Sichuan Cancer Hospital & Institute, Sichuan Cancer Center
Chengdu, China
NCT Number: NCT07294872
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs and gene-edited TILs are expanded from tumor resections and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Phase 1
Chengdu, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A tumor sample is resected from each participant and cultured ex vivo to expand the population of Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL). After lymphodepletion, patients are infused GC101 TIL.
Time frame: 6 month
To characterize the safety profile of GC101 TIL in patients with pancreatic ductal adenocarcinoma who were failed to standard treatment as assessed by incidence of adverse events.
Time frame: Up to 36 months
Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: Up to 36 months
Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: Up to 36 months
The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1
Time frame: Up to 36 months
The time from TIL infusion until disease progression or death from any cause.
Time frame: Up to 36 months
The time from TIL infusion until death from any cause.
Contact information is provided by the study sponsor or research team.
Shanghai Juncell Therapeutics
Industry
A Study Study of Tumor Infiltrating Lymphocytes Injection (GC101/203 TIL) in Patients With Advanced Solid Tumors
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