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NCT06524024

Clinical Study of Tumor Polypeptide DC-CTL in the Treatment of Solid Tumors

Sponsor: Zhengzhou Revo-Gene Technology Co., LTD

View on ClinicalTrials.gov

Summary

This clinical study is a real-world exploratory study to observe the safety and initial effectiveness of DC-CTL cells combined with conventional anti-tumor therapy in patients with colorectal cancer, esophageal cancer, lung cancer, liver cancer, breast cancer and other solid tumors.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-03-11

Completion Date

2026-04-01

Last Updated

2025-02-10

Healthy Volunteers

Conditions

Solid Tumor

Interventions

BIOLOGICAL

Tumor polypeptide pool induced DC-CTL cell injection

In this study, DC-CTL cells were injected once a day for two consecutive days, 1-2 days after study participants received a conventional antitumor regimen, and subcutaneous injections of DC cells were administered before a second infusion of DC-CTL cells. A total of about 4-6 cycles of cell infusion are required

Inclusion Criteria: 1. Age ≥18 years old, gender is not limited; 2. Patients clinically diagnosed with solid tumors such as colorectal cancer, esophageal cancer, lung cancer, liver cancer, breast cancer, etc., who need routine anti-tumor therapy; 3. KPS score ≥80 (Appendix 1), expected survival ≥3 months; 4. If imaging is available, the target lesion can be measured by conventional CT or MRI≥10 mm, and the short diameter of lymph node ≥15mm; 5. Liver function: TBIL≤3ULN, AST, ALT ≤2.5ULN; Renal function: Cr≤1.25ULN; Blood routine: WBC ≥ 4.0×109/L, Hb ≥90 g/L, PLT ≥ 80×109/L; 6. Good cardiac function (LVEF≥ 50%); 7. The peripheral superficial veins of the study participants were smooth, which could meet the needs of intravenous infusion; 8. No history of other malignant tumors, except for cured carcinoma in situ and papillary thyroid carcinoma; 9. Study participants agree to use a reliable contraceptive method for contraception from the time of signing the informed consent to the entire clinical study; 10. Study participants agree to participate in the clinical study and sign the Informed Consent form. Exclusion Criteria: 1. Pregnant or lactating women (women of childbearing age need to do pregnancy tests); 2. Had a serious, uncontrolled infectious disease (bacterial, viral, or fungal infection) within 4 weeks prior to enrollment; 3. have chronic active hepatitis, AIDS or syphilis; 4. have a serious autoimmune disease or immunodeficiency disease (such as systemic lupus erythematosus, inflammatory bowel disease, multiple sclerosis, rheumatoid arthritis, psoriasis); 5. Severe allergy; 6. serious mental disorders; 7. suffering from serious heart, liver, kidney dysfunction, serious uncontrollable diabetes and other diseases; 8. Patients who had systematically used large amounts of glucocorticoids in the 4 weeks prior to enrollment (except those who used inhaled hormones); 9. Those who have previously been treated with other gene products; 10. Other investigators consider it inappropriate to participate in the study, or other circumstances that affect the analysis of the results of this clinical study.