Overview
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 Criteria:
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- Voluntarily join the study, signed informed consent form,, willing and able to comply with the study protocol;
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2. Age 18 to 70 years old;
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3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
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4. Expected survival time of ≥ 12 weeks;
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5. Good function of vital organs;
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6. Subjects entering this study due to disease progression must have an imaging
record of disease progression before tumor sampling;
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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.