Injection of immune cells to treat advanced lung cancer

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

This study is testing if an injection of immune cells can safely help people with advanced lung cancer feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Grit Biotechnology (Industry-sponsored)
• Locations: 2 sites (Beijing, Beijing and 1 other locations)
• Trial ID: NCT06519669 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of an injection of Autologous Tumor-Infiltrating Lymphocytes (GT201) in patients with advanced lung cancer. It is designed as a single-arm, open-label intervention where participants receive the GT201 injection after meeting specific eligibility criteria. The study also aims to assess the pharmacokinetics and efficacy of the treatment in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with advanced non-small cell lung cancer or small cell lung cancer who have failed first-line systemic treatment.

Not a fit: Patients with uncontrollable tumor-related pain or those requiring unstable analgesic regimens may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced lung cancer who have not responded to standard therapies.

How similar studies have performed: While similar approaches using tumor-infiltrating lymphocytes have shown promise in other cancers, this specific application in advanced lung cancer is still being explored.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing and 1 other locations

• Beijing GoBroad Hospital — Beijing, Beijing, China (Recruiting)
• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Hongmin Lu, PHD

Conditions Adult; Lung Cancer