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

NCT06524024 | Not Yet Recruiting

• 1 other identifier: RG2401
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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, esophageal cancer, lung cancer, liver cancer, breast cancer and other solid tumors.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• PFS

  progression free survival time

  From the time of the first cell transfusion to the time of the subject's death due to any cause, up to 2 years after the subject received the last treatment

Secondary Outcomes (1)

• OS

  From the time of the first cell transfusion to the time of the subject's death due to any cause, up to 2 years after the subject received the last treatment

Study Arms (1)

Treatment

EXPERIMENTAL

Biological: DC-CTL DC combined with CTL

Biological: Tumor polypeptide pool induced DC-CTL cell injection

Interventions

Tumor polypeptide pool induced DC-CTL cell injection BIOLOGICAL

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhengzhou Revo-Gene Technology Co., LTD: lead

Study Officials

• Yi Zhang, professor

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Zhao, PhD

CONTACT

0371-63290608; revogene@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 29, 2024
• Study Start: March 11, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share