Adult, Lung Cancer
Conditions
Brief summary
This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT201 injection ) for treatment of patients with Advanced lung cancer,while evaluating pharmacokinetic characteristics and efficacy assessment.
Interventions
BIOLOGICALGT201 injection
GT201 injection to treat Advanced lung cancer
Sponsors
Grit Biotechnology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 3 years | To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator |
| Incidence and severity of adcersed events per CTCAE 5.0 | 3 years | To characterize the safety profile of autologous TIL injection（GT307) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0 |
Countries
China
Outcome results
None listed