A Study of Tumor Neoantigen-specific T Cells in the Treatment of Advanced Solid Tumors

Launched by JIANG LONGWEI · May 22, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for patients with advanced solid tumors, like ovarian cancer, non-small cell lung cancer, and colorectal cancer. The study aims to see if special immune cells, called tumor neoantigen-specific T cells, can be safely given through an IV and if they can effectively help fight these cancers. Researchers are particularly interested in how well this treatment works and how it affects the immune system.

To take part in the trial, participants need to be between 18 and 75 years old and have solid tumors that have been confirmed by medical tests. They should have already tried standard treatments without success or have chosen not to pursue further chemotherapy. Participants should also be in good enough health to follow the study's requirements and provide informed consent. Throughout the trial, participants will receive the new treatment and will be closely monitored for any side effects and overall effectiveness. This study is currently recruiting patients, and the hope is that this innovative approach could offer new hope for those facing tough cancer diagnoses.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-75 years old;
• • 2. Patients with solid malignant tumors confirmed by histology or cytology such as ovarian cancer, non-small cell lung cancer or colorectal cancer;
• • 3. Cancer patients who have failed previous standard treatments or who have refused subsequent chemotherapy and whose expected survival time exceeds 3 months;
• • 4. ECOG: 0-2 points;
• • 5. Patients of childbearing age need to take appropriate protective measures (contraceptive measures or other birth control methods) before enrollment and during the experiment;
• • 6. Those who can understand this trial and have signed the informed consent form;
• • 7. Able to follow the research protocol and follow-up procedures
• Exclusion Criteria:
• • 1. Those who have received any form of immunotherapy within the past 3 months;
• • 2. Those who need to use immunosuppressants;
• • 3. Those who have received anti-tumor treatment such as tumor chemotherapy, radiotherapy, and secondary and above surgery within the past month;
• • 4. Those who have a history of other tumors in the past, unless it is cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (Ta and TIS), or other malignant tumors that have received radical treatment (at least 5 years before enrollment) );
• • 5. White blood cell count \<3E9/L, platelet count \<80E9/L;
• • 6. AST and ALT\>3×the upper limit of normal (ULN), total bilirubin\>2×ULN, and AST and ALT\>6×ULN in patients with liver metastasis;
• • 7. Creatinine clearance \<60ml/min;
• • 8. Abnormal coagulation function;
• • 9. The patient has active bacterial or fungal infection (≥Grade 2 of NCI-CTC, third edition);
• • 10. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the peripheral blood hepatitis B virus (HBV) DNA detection value is \>100 IU/mL; hepatitis C virus (HCV) antibody is positive and the peripheral blood hepatitis C Those who are positive for hepatitis virus (HCV) RNA; those who are positive for human immunodeficiency virus (HIV) antibodies; those who are positive for cytomegalovirus (CMV) DNA; those who are positive for syphilis;
• • 11. Diseases judged by the researcher to be ineligible for inclusion: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment, uncontrollable coronary artery disease or asthma, and uncontrollable cerebrovascular disease.
• • 12. Women who are pregnant or breastfeeding, and women of childbearing age must have a negative pregnancy test within 7 days before enrollment;
• • 13. Substance abuse, clinical or psychological or social factors that affect informed consent or research implementation;
• • 14. Those who may be allergic to study drugs;
• • 15. Participate in other clinical trials one month before registration;
• • 16. Patients who cannot undergo mononuclear cell separation or whose peripheral venous access cannot be opened;
• • 17. Any uncertain factors that affect patient safety or compliance;
• • 18. Other researchers believe that the subject is not suitable for inclusion.