GT201 Injection in Combination with Teraplizumab Injection for Treatment of Patients with 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
Grit Biotechnology
20 participants
Feb 2, 2024
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria7
- \. Voluntarily join the study, signed informed consent form,, willing and able to comply with the study protocol;
- \. Age 18 to 70 years old;
- \. 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.
Exclusion Criteria5
- 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.
Interventions
GT201 injection in combination with teraplizumab injection for treatment of patients with non-small cell lung cancer
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06235242