a Polyphenol Whole Tumor Cell Vaccine in Patients With Advanced Malignant Solid Tumors
NCT06878612 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2025-06-05
Summary
This project intends to carry out phase I clinical studies on the basis of the previous work, initially exploring the possible effective dose, evaluating its safety and tolerability, with a view to achieving long-term control of the disease, which is expected to provide more options for the treatment of patients with advanced malignant solid tumors. The development of this project will provide new ideas, strategies and theoretical basis for the research and development of whole tumor cell vaccines; at the same time, it is expected to obtain original new drugs with independent intellectual property rights.
Conditions
- Polyphenols
- Cancer Vaccine
- Advanced Solid Tumor
Interventions
- BIOLOGICAL
-
Polyphenol whole tumor cell vaccine
3 patients enrolled in each dose group, and planned dose groups of 5 x 10\*6, 2 x 10\*7, and 5 x 10\*7 cells/dose. The dosing regimen consisted of 5 doses of basal immunization and subsequent individualized treatment. In the basal immunization, the administration times were D0, D14, D28, D42, and D56. After completion of the 5 doses of basal immunization, the subsequent individualized treatment was decided by the investigator based on the subject's tumor assessment, i.e., 1 vaccination per month for a total of 4 doses.
Sponsors & Collaborators
-
Xingchen Peng
lead OTHER
Principal Investigators
-
Xingchen Peng, Professor · Department of Biotherapy, West China Hospital, Sichuan University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-21
- Primary Completion
- 2026-08-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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