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

Grit Biotechnology

Status: Enrolling

Conditions: Adult; Lung Cancer

Treatments: Biological: GT201 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06519669

GRIT-CD-CHN-201-016

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

GT201 treatment group

Experimental group

Treatment:

Biological: GT201 injection