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20 participants are expected to be enrolled for the Phase Ib clinical trial,this trail is expected to be finished in 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Participants with advanced NSCLC using cryopreserved GC101 TIL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Tumor Infiltrating Lymphocytes | Biological | A tumor sample is resected from each participant and cultured ex vivo to generate tumor infiltrating lymphocytes. After lymphodepletion, patients are infused GC101 TIL followed low-dose PD-1 antibody. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Incidence of adverse events associated with GC101 TIL retransfusion | Up to Day 28 |
| Objective Response Rate | Proportion of subjects in total cases in complete or partial response (RECIST v1.1 criteria) | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Incidence of adverse events associated with GC101 TIL retransfusion | Maximum 360 days |
| Objective Response Rate | Proportion of subjects in total cases in complete or partial response (RECIST v1.1 criteria) during the study |
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Inclusion Criteria:
1. Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol;
2. Aged ≥18 years and ≤70 years, regardless of gender;
3. Patients with unresectable advanced, recurrent, or metastatic non-small cell lung cancer who are positive for driver genes and have failed after targeted and platinum-containing dual chemotherapy;
4. TILs can be isolated from a surgically resectable tumor region: the tissue volume must be >150mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency ablation, oncolytic virus, etc.) or progressed after local treatment;
5. There are still at least 1 measurable lesion (according to RECIST1.1 criteria [see Appendix 4]) even after TIL sampling and resection of surgically resectable tissue;
6. ECOG performance status 0-1;
7. Expected survival time >3 months;
8. With sufficient hematology and end-organ function as defined by the following laboratory test results, the test results must be completed and issued within 7 days before tumor tissue collection:
9. * Premenopausal women who have not undergone sterilization surgery must agree to use effective contraception measures from the start of study treatment (preconditioning) to one year after cell infusion, and the serum pregnancy test during the screening period must be negative; *Men who have not undergone sterilization surgery must agree to use effective contraception measures from the start of study treatment (preconditioning) until one year after cell infusion;
10. No absolute or relative contraindications for surgery;
11. Any melanoma treatment methods, including radiotherapy, chemotherapy, endocrine therapy, targeted therapy, immunotherapy, tumor embolization, or traditional Chinese medicine/herbal medicine treatment with anti-tumor indications, must be stopped 28 days before infusion. If a small molecular targeted drug was used in the previous treatment, the withdrawal time can be shortened to 5 half-lives of the drug used;
12. Good compliance and able to adhere to the study visit plan and other agreement requirements.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shun Lu, M.D. | Contact | 86-021-22200000 | shunlu_shchest@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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|
| Maximum 36 months |
| Best overall response | Optimal efficacy recorded from the start of treatment until disease progression or relapse (RECIST v1.1 and iRECIST) | Maximum 36 months |
| Disease Control Rate | Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST | Maximum 36 months |
| Progression-Free Survival | Evaluate the efficacy endpoints of PFS by the investigator with RECIST v1.1 and iRECIST | Maximum 36 months |
| Duration of Response | Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST | Maximum 36 months |
| overall survival | Evaluate the efficacy endpoints of OS | Maximum 36 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |