Third Affiliated Hospital of Naval Medical University
Shanghai, China
Location status: Recruiting
Location contact
Qian Zhang
PRINCIPAL_INVESTIGATOR
Wenlong Yu
PRINCIPAL_INVESTIGATOR
Xiaoyun Tai
CONTACT
NCT Number: NCT06488950
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 or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Early Phase 1
Shanghai, China
Location status: Recruiting
Qian Zhang
PRINCIPAL_INVESTIGATOR
Wenlong Yu
PRINCIPAL_INVESTIGATOR
Xiaoyun Tai
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
the candidates will be assigned to GC203 TIL(gene-edited TIL) group or autologous TILs group according the volume of TIL sample
Time frame: 6 months
To characterize the safety profile of TILs in patients with advanced solid tumors 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
Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST 1.1
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 length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1
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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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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