A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT201 Injection ) for Treatment of Patients with Advanced Lung Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT201 injection ) for treatment of patients with Advanced lung cancer,while evaluating pharmacokinetic characteristics and efficacy assessment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 1\. Voluntarily join the study, signed informed consent form,willing and able to comply with the study protocol;

• 2\. Age 18 to 70 years old;

• 3\. Queue 1: Late stage non-small cell lung cancer without driver genes that have failed first-line systemic treatment;Queue 2: Small cell lung cancer with first-line systemic treatment failure;

• 4\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;

• 5\. Expected survival time of ≥ 12 weeks;

• 6\. Good function of vital organs;

• 7\. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;

• 8\. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

Locations
Other Locations
China
Beijing GoBroad Hospital
RECRUITING
Beijing
Renji Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Hongmin Lu, PHD
renjilhm@163.com
+86 (021)13671774876
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2027-07-18
Participants
Target number of participants: 40
Treatments
Experimental: GT201 treatment group
Related Therapeutic Areas
Sponsors
Leads: Grit Biotechnology

This content was sourced from clinicaltrials.gov

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