Autologous Tumor-Infiltrating Lymphocyte Injection(GT201) for Treatment of Patients with Advanced Lung Cancer

Not Applicable

Recruiting

• Conditions: Adult; Lung Cancer
• Interventions: Biological: GT201 injection

• Registration Number: NCT06519669
• Lead Sponsor: Grit Biotechnology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-18
• Study First Submitted: 2024-07-19
• Study First Submitted QC: 2024-07-19
• Study First Posted: 2024-07-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2027-07-18
• Study Completion: 2027-07-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
• 2.Known mental illness, alcoholism, drug use or substance abuse;
• 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
• 4.Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;
• 5.The investigators determine that other conditions that make the patient not suitable for enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GT201 treatment group	GT201 injection	-

Primary Outcome Measures

Name	Time	Method
Objective response rate	3 years	To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator
Incidence and severity of adcersed events per CTCAE 5.0	3 years	To characterize the safety profile of autologous TIL injection（GT307) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0

Trial Locations

Locations (2)

Beijing GoBroad Hospital; 🇨🇳 Beijing, Beijing, China

Renji Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China