Using GT201 and Teraplizumab to treat Non-small Cell Lung Cancer

A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT201 Injection ) in Combination with Teraplizumab Injection for Treatment of Patients with Non-small Cell Lung Cancer

This study is testing a new treatment combining GT201 and teraplizumab to see if it helps people with non-small cell lung cancer feel better and improve their health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Grit Biotechnology (Industry-sponsored)
• Drugs / interventions: teraplizumab
• Locations: 3 sites (Beijing, Beijing and 2 other locations)
• Trial ID: NCT06235242 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of GT201 injection, which consists of autologous tumor-infiltrating lymphocytes, in combination with teraplizumab injection for patients with non-small cell lung cancer. It is a single-arm, open-label design that aims to assess pharmacokinetic characteristics and efficacy to determine the optimal biological dose. Participants will be monitored for their response to the treatment and overall health during the study period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a performance status of 0 or 1 and measurable disease progression.

Not a fit: Patients with uncontrollable tumor-related pain or significant mental health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with non-small cell lung cancer.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in using immunotherapy for cancer treatment, indicating potential for success.

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. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
* 4. Expected survival time of ≥ 12 weeks;
* 5. Good function of vital organs;
* 6. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
* 7. 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 2 other locations

• Beijing Gobroad Hospital — Beijing, Beijing, China (Recruiting)
• Shanghai East Hospital — Shanghai, Shanghai, China (Not_yet_recruiting)
• Shanghai GoBroad Cancer Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Yayi He, PHD

Conditions Adult; Non-small Cell Lung Cancer; GT201