Using T cells that target tumor neoantigens to treat advanced solid tumors

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

This study is testing if infusions of specially made T cells that target tumor markers can help people with advanced solid tumors like ovarian, lung, and colorectal cancer feel better and improve their health.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jinling Hospital, China (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06431529 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of intravenous infusions of tumor neoantigen-specific T cells in patients with advanced solid tumors, including ovarian cancer, non-small cell lung cancer, and colorectal cancer. Patients will have their tumor specimens collected, and their peripheral blood mononuclear cells (PBMC) will be separated and cultured in a GMP laboratory to create the specific T cells. The study will assess both the immunological properties of these T cells and their potential to improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced solid tumors who have failed previous standard treatments or have refused further chemotherapy.

Not a fit: Patients who have received immunotherapy within the past 3 months or require immunosuppressants may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel immunotherapy option for patients with advanced solid tumors who have limited treatment options.

How similar studies have performed: Other studies have shown promise with similar approaches using neoantigen-specific T cells, indicating potential for success in this novel treatment strategy.

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.

Where this trial is running

Nanjing, Jiangsu

• Nanjing Jinling Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Jiang Longwei, Master

Conditions Tumor, Solid; Solid tumor; T cell; neoantigen