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

GRIT-CD-CHN-201-002

This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT201 injection ) in combination with teraplizumab injection for treatment of patients with non-small cell lung cancer,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).

2024-02-02

2027-01-31

2027-01-31

Recruiting

20

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-03-19