Lung cancer
Conditions
Interventions
Low dose group:Accept approximately 1.0 × 10 ^ 8 cell dose therapy
High dose group:Accept approximately 2.4 × 10 ^ 8 cell dose therapy
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with advanced NSCLC who have previously received = third-line treatment and tested positive for NKG2D ligand expression on the surface of lung cancer tissue cells; patients with driver gene mutations may enroll after discontinuing targeted therapy. 2. Aged =18 years and =75 years at the time of signing the informed consent form (ICF). 3. At least one measurable lesion. 4. Ability to establish venous access for blood collection and cell reinfusion. 5. Adequate bone marrow reserve, with peripheral blood WBC count =3 × 10^9/L and hemoglobin >90 g/L. 6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 × upper limit of normal (ULN); serum total bilirubin =1.5 × ULN. 7. Serum creatinine =2.5 × ULN. 8. Fibrinogen =1.0 g/L, activated partial thromboplastin time (APTT) =1.5 × ULN, and prothrombin time (PT) =1.5 × ULN. 9. Left ventricular ejection fraction >50%. 10. Life expectancy of at least 3 months. (Note: Patients must consent to baseline assessment and provide lung cancer tissue sections suitable for immunohistochemistry and flow cytometry analysis. Patients who have previously received chemotherapy, immunotherapy, or molecular targeted therapy must complete the required drug washout period before becoming eligible for reinfusion.)
Exclusion criteria
Exclusion criteria: 1. Subjects with central nervous system metastases. 2. Subjects who have received another anti-tumor therapy within two weeks prior to the planned blood collection. 3. Subjects who have previously received gene therapy. Subjects who have received or plan to receive any other investigational treatment within 3 weeks before the scheduled first dose of PSDR-CAR-T cells. 4. Subjects planning to receive growth factors, systemic corticosteroids, other immunosuppressive therapies, or cytotoxic drugs, except those who have recently used inhaled corticosteroids. 5. Subjects who have undergone major surgery within 4 weeks before the first dose of PSDR-CAR-T cells. 6. Pregnant or lactating women. Female subjects of childbearing potential must undergo hormone level testing within 48 hours before infusion to exclude the possibility of pregnancy. 7. Subjects with a history of severe infection (NCI CTCAE v5.0 = Grade 3) before the first dose, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications, or those with active infection requiring systemic treatment within 2 weeks before the first dose. Subjects receiving prophylactic antibiotics (e.g., for urinary tract infection or chronic obstructive pulmonary disease exacerbation) may be eligible after discussion with the sponsor. 8. Subjects with active hepatitis B or hepatitis C virus carriers, as well as those with active autoimmune diseases. 9. Subjects testing positive for HIV and Syphilis. 10. Subjects with pleural or peritoneal effusion requiring repeated drainage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Overall Survival (OS);Incidence of Adverse Events (AE) and Serious Adverse Events (SAE);Duration of Response (DOR);Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Long-term immune status of subjects after infusion completion, such as CD4/CD8 ratio;Changes in Peripheral Blood Tumor Marker Levels;Survival and Subpopulation Proportion of PSDR-CAR-T Cells in Subjects; | — |
Countries
China
Contacts
Public ContactCheng Yuan
Beijing Chao-yang Hospital
Outcome results
None listed