Status:
NOT_YET_RECRUITING
Clinical Study of Tumor Polypeptide DC-CTL in the Treatment of Solid Tumors
Lead Sponsor:
Zhengzhou Revo-Gene Technology Co., LTD
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, ...
Detailed Description
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, ...
Eligibility Criteria
Inclusion
- Age ≥18 years old, gender is not limited;
- 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;
- KPS score ≥80 (Appendix 1), expected survival ≥3 months;
- 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;
- 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;
- Good cardiac function (LVEF≥ 50%);
- The peripheral superficial veins of the study participants were smooth, which could meet the needs of intravenous infusion;
- No history of other malignant tumors, except for cured carcinoma in situ and papillary thyroid carcinoma;
- Study participants agree to use a reliable contraceptive method for contraception from the time of signing the informed consent to the entire clinical study;
- Study participants agree to participate in the clinical study and sign the Informed Consent form.
Exclusion
- Pregnant or lactating women (women of childbearing age need to do pregnancy tests);
- Had a serious, uncontrolled infectious disease (bacterial, viral, or fungal infection) within 4 weeks prior to enrollment;
- have chronic active hepatitis, AIDS or syphilis;
- have a serious autoimmune disease or immunodeficiency disease (such as systemic lupus erythematosus, inflammatory bowel disease, multiple sclerosis, rheumatoid arthritis, psoriasis);
- Severe allergy;
- serious mental disorders;
- suffering from serious heart, liver, kidney dysfunction, serious uncontrollable diabetes and other diseases;
- Patients who had systematically used large amounts of glucocorticoids in the 4 weeks prior to enrollment (except those who used inhaled hormones);
- Those who have previously been treated with other gene products;
- Other investigators consider it inappropriate to participate in the study, or other circumstances that affect the analysis of the results of this clinical study.
Key Trial Info
Start Date :
March 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06524024
Start Date
March 11 2025
End Date
April 1 2026
Last Update
February 10 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.