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