Dual-targeting VEGFR1 and PD-L1 CAR-T for Cancers Patients With Pleural or Peritoneal Metastases

Launched by SICHUAN UNIVERSITY · Jul 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with advanced cancers that have spread to the serosal cavities, which are the spaces in the body that hold organs like the lungs and abdomen. The treatment involves a type of personalized therapy called CAR-T, which is designed to target specific proteins (VEGFR1 and PD-L1) found in certain cancers, such as ovarian, breast, lung, and gastric cancers. The goal is to see if this dual-targeting approach can improve the quality of life and survival for these patients.

To participate, individuals must be between 18 and 65 years old and have specific types of cancer with related symptoms. They should have received standard treatments before and be in reasonably good health, meaning they have a life expectancy of at least three months and meet certain blood count and organ function criteria. Participants will receive the CAR-T therapy and will be closely monitored for any side effects. It’s important for patients to understand the requirements and possible risks, and they must provide informed consent to join the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female, Age 18-65 years old; negative results of serum or urine pregnancy test within 48 hours before treatment are needed to provide for fertile women (or women who have undergone sterilization or at least 2 years after menopause can be regarded as infertile);
• • 2. Patients diagnosed as ovarian cancer, non-small cell lung cancer, breast cancer, gastric cancer, etc., accompanied by serous cavity metastasis, have received systemic standard treatment, and have clinical symptoms of serous cavity metastasis;
• • 3. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;
• • 4. Estimated life expectancy ≥ 3 months (according to investigator's judgement);
• • 5. Absolute neutrophil count ≥ 1.5×10\^9/L, platelet count ≥ 90×10\^9/L, absolute lymphocyte count ≥1×10\^8/L, hemoglobin ≥ 9.0 g/dL;
• • 6. Creatinine clearance rate ≥60 mL/min, Serum ALT/AST≤2.5 times of the normal level, and total bilirubin≤1.5 times of the normal level;
• • 7. Cardiac ejection fraction ≥50%, no pericardial effusion;
• • 8. No other serious diseases (autoimmune diseases or any immune deficiency disease or other disease in need of immunosuppressive therapy);
• • 9. Patients must stop chemotherapy and targeted therapy for at least 3 weeks before starting treatment;
• • 10. Patients must take reliable contraceptive measures before entering the trial, during the research process until 1 year after CAR-T infusion; reliable contraceptive measures will be determined by the main investigator or designated personnel;
• • 11. Voluntarily participate in the research, understand and sign the informed consent;
• • 12. The side effect of the last anti-tumor treatment was reduced to ≤1 grade, except for hair loss.
• Exclusion Criteria:
• • 1. Had accepted any treatment of CAR-T therapy;
• • 2. Allergic to cytokines; uncontrolled activity infection;
• • 3. Acute or chronic (graft-versus-host disease) GVHD;
• • 4. Accompanied by other uncontrolled malignant tumors;
• • 5. Patient with hepatitis B or C active period, HIV infection ≥ the upper limit of the normal level;
• • 6. Other uncontrolled diseases in active period that hinder participation in the trial;
• • 7. Suffer from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, etc.;
• • 8. Patients with grade 2-3 hypertension or poorly controlled;
• • 9. History of mental illness that is difficult to control;
• • 10. Patients have used immunosuppressive agents for a long time after organ transplantation, except for recent or current inhaled corticosteroid therapy;
• • 11. The existing medical history or mental state history or laboratory abnormalities may increase the risk associated with participating in the study or the administration of the study drug from the point view of PI;
• • 12. Unstable pulmonary embolism, deep venous embolism or other major arterial/venous thromboembolic events occurred within 6 months before enrollment. If receiving anticoagulant therapy;
• • 13. Pregnant or nursing women, or plan to become pregnant during the treatment period or within 1 year after the treatment ends;
• • 14. Female subjects of childbearing age were reluctant to accept high-efficiency contraceptive measures during the treatment period or within 1 year after the treatment ends;
• • 15. Patient suffering from diseases that have signed written informed consent or comply with research procedures; or are unwilling or unable to comply with research requirements;
• • 16. Patients who are inappropriate to participate in this experiment as considered by PI.