Non-small cell lung cancer
Conditions
Interventions
Case Group:Natural Killer–Like Cells as a Third-line or Further Treatment
Sponsors
The First People's Hospital of Foshan
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient or his legal guardian voluntarily participates in this study, knows and is willing to bear the adversed events of the treatment, and fills in and signs the informed consent form; 2. Aged between 18 -75 years; no gender limit; 3. Pathologically confirmed stage IV non-small cell lung cancer patients who have progressed after standard second-line treatment in the past; 4. A sufficient number of T cells can be taken through the vein (to obtain CD3 + T cells> 6×107), and there are no other contraindications; 5. Patients with normal organ function: (1) Liver function: ALT/AST = 60mL/min; (3) Lung function: blood oxygen saturation >= 95%, and no active lung infection; (4) Cardiac function: left ventricular ejection fraction (LVEF) >= 50%; and there is no large pericardial effusion, no clinically significant ECG abnormalities; 6. Women of childbearing age who have a negative pregnancy test during the screening period and agree to use contraceptive measures at least 1 year after infusion; male subjects with fertile partners must agree to use effective barrier contraceptive methods for at least 1 year after infusion; 7. ECOG PS Scoring <= 1; 8. Before the first use of the trial drug treatment, all reversible toxicity of the previous anti-tumor therapy returned to <= 1 (according to CTCAE V5.0) or after the investigator's assessment, the subject considered that the benefit of the study treatment was greater than the risk of toxicity.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant (positive urine/blood pregnancy test) or breastfeeding; 2. Men or women who have a conception plan within the past year; 3. Effective contraceptive measures (condoms or contraceptives, etc.) cannot be guaranteed within one year after joining the group; 4. The patient had an uncontrollable infection within 4 weeks before enrollment; 5. Active hepatitis B/C; 6. HIV-infected patients; 7. Suffered from severe autoimmune diseases or immunodeficiency diseases; 8. The patient is allergic and is allergic to macromolecular biological drugs such as antibodies or cytokines; 9. The patient has participated in other clinical trials within 4 weeks before enrollment; 10. A history of clinically significant central nervous system diseases: such as epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome; 11. Suffered from mental illness; 12. The patient has drug abuse/addiction; 13. In the feasibility evaluation experiment, the amplification ability of CD3/CD28 magnetic beads after activation is less than 5 times; 14. Use prohibited drugs: (1) Hormones: A therapeutic dose of corticosteroid (defined as prednisone or equivalent> 20 mg/day) has been used within 7 days before leukocyte collection or within 72 hours before CART-T administration. However, physiological replacement, topical, and inhaled steroids are allowed. (2) Chemotherapy: Receive rescue chemotherapy within 2 weeks before white blood cell collection. (3) Allogeneic cell therapy: received donor lymphocyte infusion within 4 weeks before white blood cell collection. (4) History of allogeneic hematopoietic liver cell transplantation or organ transplantation. (5) Have used alemtuzumab within 6 months before white blood cell collection, or used clofarabine or cladribine within 3 months. (6) According to the judgment of the investigator, the patient has other unsuitable conditions for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression-free Survival;The occurrence of adverse events related with the therapy; | — |
Countries
China
Contacts
Public ContactFeng Weineng
The First People's Hospital of Foshan
Outcome results
None listed