Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT03330834
Eligibility Criteria:
Inclusion Criteria:
1. Subjects were diagnosed with NSCLC by pathology and at clinical stages ⅢB/Ⅳ based on the 8th Union for International Cancer Control/American Joint Committee on Cancer (UICC/AJCC) Staging System or the disease has recurred or progressed after multi-mode therapy (radiotherapy, surgical excision or radical radiotherapy/chemotherapy to treat local advanced lesions ).
2. Subjects whose recurrent or advanced NSCLC has progressed after standard treatments (operation, radiotherapy and targeting therapy, not including PD-1/PD-L1 checkpoint inhibition therapy) or who are reluctant to receive chemotherapy.
3. Subjects should undertake core needle biopsy again to collect at least one fresh biopsy specimen and at least 10 non-stained sections before recruitment.
4. TKI or chemotherapeutic should be discontinued at least 21 days before Day 0 of the clinical trial while radiotherapy of lung cancer at least 6 months before Day 0 of the clinical trial . Subjects should receive baseline imaging scan after the previous treatments are suspended.
5. Lesions must be detected by CT or MRI according to RECIST 1.1 Criteria. Tumor imaging should be performed at least within 28 days before the beginning of the clinical study.
6. Age\>=18 years old and weight \>=40kg.
7. PD-L1 is positive by IHC in tissue biopsies of progressive lung cancer after standard treatments(\>10%).Ventana PD-L1 (SP142) approved by FDA is used to detect PD-L1 expression level on participated patients' lung cancer sections.
8. Life expectancy\>=12 weeks
9. Eastern Cooperative Oncology Group (ECOG) score≤ 2
10. Blood pregnancy tests should be negative within 14 days before the woman of childbearing age starts treatment and agrees to take contraceptive methods with a failure rate of no more than 1% per year until the final follow-up.Contraceptive methods with a failure rate of no more than 1% per year include tubal ligation, vasectomy, hormonal contraceptives, intrauterine hormone release system and copper intrauterine device (IUDs).
11. Hematology and liver and kidney functions should meet the following laboratory values. These laboratory tests should be completed in 7 days before the first therapeutic cell infusion.
Tests and Laboratory Values:
Hematology:
1. White Blood Cell (WBC): \>=3.5\*10\^9/L;
2. Absolute Neutrophil Count (ANC): \>=1.5\*10\^9/L;
3. Hemoglobin (HGB): \>=90g/L;
4. Platelet (PLT): \>=80\*10\^9/L;
Blood Coagulation Function:
PT、APTT、FIB、TT: within normal limits;
Liver Function:
1. Aspartic Transaminase (AST): \<2.5\*upper normal limits(ULN)(hepatic metastasis subjects with 0-1 ECOG score \< 5\*ULN);
2. Alanine Aminotransferase (ALT): \<2.5\*ULN(hepatic metastasis subjects with 0-1 ECOG scorer \< 5\*ULN);
3. Total Bilirubin (TIBC): \<1.5\*ULN;
Kidney Function:
Serum Creatinine (CR): \<1.0\*ULN.
12. Subjects are willing to participate in this study and agree to sign the Informed Consent.
Exclusion Criteria:
1. Subjects who are receiving systematic steroid treatments 3 days before the first cell treatment.
Notice:
1. Corticosteroids can be used to treat adverse event (AE) and serious adverse event (SAE) after the experimental cell treatment.
2. Subjects who receive steroid replacement therapy everyday can be included in the clinical study. Prednisone therapy in a dose of 5-7.5mg/day is replacement therapy.
3. Subjects who receive equivalent dose of hydrocortisone treatment as replacement therapy are also allowed into the clinical trial.
2. Subjects who have received systematic cytotoxic chemotherapy, biological therapy or major operations in 3 weeks before the first dose of experimental cell therapy or subjects who have received lung radiation more than 30 gray (Gy) in 6 months before the first dose of experimental cell therapy.
3. Subjects who have received previous cell treatments such as CAR-T and cytokine-induced killer (CIK) cells or anti-PD-1 or anti- PD-L1 antibody treatment.
4. Subjects with confirmed Central Nervous System (CNS) metastasis and/or carcinomatous meningitis.
Notice:
Subjects who have received brain metastasis treatments are allowed in this study, in the case that subjects' conditions are stable (no CNS symptoms) and no radiographic evidence of new or extensive brain metastasis is found at least 4 weeks after the treatments (such as operation or RT). Subjects should suspend hormone treatment at least 3 days before the first dose of experimental cell treatment.
5. Subjects with active autoimmune diseases who need systematic treatments (such as disease improving drugs, corticosteroids and immunosuppressive drugs) in the last 2 years.
Notice:
Replacement therapy (thyroxine, insulin or physiological corticosteroid replacement therapy to treat adrenal dysfunction or pituitary dysfunction) is not considered as systematic therapy. Subjects who need inhalation corticosteroid therapy can be included in this trial. Subjects with vitiligo or in long-term remission of pediatric asthma or allergic diseases can be included in this trial.
6. Subjects with interstitial pneumonia or a history of pneumonia with oral or intravenous steroid treatments.
7. Subjects whose lymphocytes are difficult to transduce (\<20%) or can not proliferate over 5 times.
8. Subjects who have received allotransplantation or solid organ transplantation.
9. Subjects who have received or will receive live vaccines in 30 days before the first experimental cell treatment. Inactivated seasonal flu vaccination is allowed.
10. Subjects with active infections who need intravenous systematic treatments.
11. Subjects with a history of human immunodeficiency virus (HIV)（HIV 1/2 antibody positive）infection.
12. Subjects with known active hepatitis B or hepatitis C. Subjects with HBsAg positive will be excluded. The definition of active hepatitis C is that hepatitis C antibody is positive while quantitative hepatitis C virus (HCV) RNA results exceed the lower detection limit.
13. Subjects with a history of mental disorders or drug abuse that may influence treatment compliance.
14. Women in pregnancy or lactation or are expected to be pregnant during the study (from the screening and to 60 days after the final experimental cell treatment) or men whose wives are in pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03330834
Study Brief:
Protocol Section:
NCT03330834