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Not Yet Recruiting NCT06524024

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

Conditions: Solid Tumor

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Zhengzhou Revo-Gene Technology Co., LTD

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06524024). StuddyBuddy aggregates publicly available trial information.