Clinical trial · Interventional
Autologous Tumor-Infiltrating Lymphocyte Injection(GT201) for Treatment of Patients With Advanced Lung Cancer
A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT201 Injection ) for Treatment of Patients With Advanced Lung Cancer
NCT06519669CI-TRIAL-00109554terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated from a business perspective.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GT201 injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GT201 treatment group
- interventionNames
- Biological: GT201 injection
Primary outcomes (2)
- measure
- Objective response rate
- timeFrame
- 3 years
- description
- To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator
- measure
- Incidence and severity of adcersed events per CTCAE 5.0
- timeFrame
- 3 years
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.