Zhengzhou Revo-Gene Technology Assesses DC-CTL Cells for the Treatment of Solid Tumors in Real World Exploratory Study

Zhengzhou Revo-Gene Technology is currently evaluating a tumor polypeptide pool induced dendritic cell-cytotoxic T-lymphocyte (DC-CTL) cell injection for the treatment of various solid tumor types in a real-world exploratory clinical study (NCT06524024).¹ For this installment of Clinical Trials in Progress, CGTLive® has decided to take a closer look at this active study.

The study, which may enroll from 20 to 200 participants in total, will administer the DC-CTL cells 1 to 2 days after the patients have received conventional antitumor therapy. Specifically, patients will receive 1 injection per day of the DC-CTL cells for 2 consecutive days. In addition, the patients will receive DC cells in subcutaneous injections before a second infusion of DC-CTL cells. All told, patients are expected to be given 4 to 6 cycles of cell infusion depending on clinical needs and test results. Yi Zhang, MD, PhD, a professor at The First Affiliated Hospital of Zhengzhou University, is serving as the principal investigator for the study.

According to the clinicaltrials.gov page, which was most recently updated on February 10, 2025, the study was initiated on March 11, 2025, but has not yet begun recruiting patients. The study has an estimated completion date of April 1, 2026.

The study’s primary end point is progression-free survival time as measured from the time of the first DC-CTL cell infusion to the patient’s death from any cause for up to 2 years from the most recent treatment with DC-CTL cells. The secondary end point of the study is overall survival time as measured from the time of the first DC-CTL cell infusion to the patient’s death from any cause for up to 2 years from the most recent treatment with DC-CTL cells.

(Click to enlarge)

The study is open to patients aged 18 years and older who have clinically diagnosed solid tumors of various types and require antitumor therapy on a routine basis. Examples of solid tumor types specifically listed as applicable for the study are colorectal cancer, esophageal cancer, lung cancer, liver cancer, and breast cancer, although it is noted that “other solid tumor types” are also included. Patients are additionally required to have a Karnofsky Performance Scale score of at least 80 and an expected survival time of at least 3 months. If imaging is available, participants must have at least 1 measurable target lesion, defined as a lesion of at least 10mm in diameter by conventional CT or MRI, with the short diameter of the lymph node being at least 15 mm. Adequate organ and marrow function must be demonstrated at screening, including a total bilirubin of no more than 3 times the upper limit of normal (ULN), aspartate aminotransferase and alanine transaminase levels of no more than 2.5 times ULN, creatinine levels of no more than 1.25 times ULN, a white blood cell count of at least4.0 × 10⁹/L, a hemoglobin count of at least 90 g/L, and platelet count of at least 80 × 10⁹/L. Cardiac function must be considered good, with a left ventricular ejection fraction (LVEF) of at least 50%. Peripheral superficial veins must be adequately smooth to support intravenous infusion as required by the study protocol. Participants must have no prior history of other malignancies, with the exception of previously cured carcinoma in situ or papillary thyroid carcinoma. All patients must agree to use effective contraception from the time of informed consent through the entirety of study participation.

Participants will be excluded if they are pregnant or breastfeeding; all women of childbearing potential must undergo pregnancy testing before enrollment. Additional exclusion criteria cover the presence of any serious, uncontrolled infectious disease within 4 weeks before enrollment; known chronic active hepatitis, AIDS, or syphilis; and presence of any serious autoimmune or immunodeficiency diseases, with examples listed covering systemic lupus erythematosus, inflammatory bowel disease, multiple sclerosis, rheumatoid arthritis, and psoriasis. Patients with a severe allergy; serious mental disorder; serious dysfunction of the heart, liver, or kidneys; serious uncontrollable diabetes; and other comorbid diseases will also be excluded. The use of systemic glucocorticoids at high doses within 4 weeks before enrollment is not permitted, with the exception of inhaled hormones. Prior exposure to gene therapy products constitutes an additional exclusion criteria. Participants may also be excluded if, in the judgment of any investigator, any other clinical condition or circumstance is present that is deemed inappropriate or to interfere with assessments of outcomes.

The study is not the first to have evaluated the use of DC-CTL cells in treating cancer. A phase 1/2 clinical trial (NCT04672473) was launched on October 30, 2020, with the intent of assessing antigen peptide-specific DC-CTL cells and decitabine for the treatment of malignant tumors.² Although, the study’s clinicaltrials.gov page has not been updated since December 17, 2020, and it is listed as having an unknown status despite its estimated completion date being listed as July 28, 2023. According to the page, it was recruiting patients at Shenzhen University General Hospital in Guangdong, China, which is the sponsor of the study.

REFERENCES
1. Clinicaltrials.gov. Clinical study of tumor polypeptide DC-CTL in the treatment of solid tumors (DC-CTL). Website. Accessed June 23, 2025. https://clinicaltrials.gov/study/NCT06524024?term=NCT06524024&rank=1
2. Clinicaltrials.gov. Treatment of malignant tumors with antigen peptide-specific DC-CTL cells and decitabine. Website. Accessed June 23, 2025. https://clinicaltrials.gov/study/NCT04672473