NCT06524024

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Zhengzhou Revo-Gene Technology Co., LTD · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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, esophageal cancer, lung cancer, liver cancer, breast cancer and other solid tumors. 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, and the specific number of infusion and the composition of the peptide pool are determined by the investigator based on clinical needs and test results. After the cells have been transfused, their safety is examined first, and their effectiveness is evaluated during follow-up. According to the needs, this study plans to enroll about 20-200 patients with solid tumors such as colorectal cancer, esophageal cancer, lung cancer, liver cancer, and breast cancer. If the disease progresses during treatment, it is evaluated comprehensively by the investigator according to the clinical situation to determine whether the patient can be withdrawn from the study. Study participants in the follow-up phase who develop disease progression, begin other anti-tumor therapy without reaching disease progression after infusion, and voluntarily request to withdraw from the follow-up phase will be withdrawn from the follow-up phase and will be followed for survival only.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-03-11
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-07-29
• Last updated: 2025-02-10