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

NCT06519669 | Terminated

• 1 other identifier: GRIT-CD-CHN-201-016
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Adult; Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Objective response rate

  To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator

  3 years

• Incidence and severity of adcersed events per CTCAE 5.0

  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

  3 years

Study Arms (1)

GT201 treatment group

EXPERIMENTAL

Biological: GT201 injection

Interventions

GT201 injection BIOLOGICAL

GT201 injection to treat Advanced lung cancer

GT201 treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntarily join the study, signed informed consent form，willing and able to comply with the study protocol;
• \. Age 18 to 70 years old;
• \. 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;
• \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• \. Expected survival time of ≥ 12 weeks;
• \. Good function of vital organs;
• \. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
• \. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

You may not qualify if:

• 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;
• Known mental illness, alcoholism, drug use or substance abuse;
• Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
• 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;
• The investigators determine that other conditions that make the patient not suitable for enrollment.

Sponsors & Collaborators

• Grit Biotechnology: lead

Study Sites (2)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102200, China

Location

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 25, 2024
• Study Start: July 18, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

CN (2)