NCT06708936

KSD-201 Treatment for Advanced Clear Cell Renal Cell Carcinoma: an Early Exploratory Clinical Study

A Single-arm, Open-label, Single-center, Multiple-dose Early Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of KSD-201 in Patients With Advanced Clear Cell Renal Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Kousai Bio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpse of this study is to evaluate the safety and tolerability of KSD-101 in patients with advanced clear cell renal cell carcinoma, to evaluate the initial clinical outcomes , immune response, and to evaluate the impact of KSD-201 on the quality of life in patients with advanced clear cell renal cell carcinoma.

Detailed description

This study is a single-center, single-arm, open-label, dose-confirmation clinical trial designed to evaluate the safety, tolerability, immune response, and preliminary clinical efficacy of KSD-201 in the treatment of patients with advanced clear cell renal cell carcinoma. The study is conducted in two phases: the first phase is for dose-limiting toxicity (DLT) observation and dose confirmation; the second phase is an expansion study, where the investigators may add 3 to 6 subjects based on the safety and efficacy signals obtained from the first phase. Enrolled subjects will undergo peripheral blood mononuclear cell collection. The collected material is transported via cold chain logistics to the dendritic cell vaccine preparation site, where the dendritic cell vaccine (KSD-201) is prepared using the subject's own monocytes. Once KSD-201 is successfully prepared, subjects will return to the hospital for KSD-201 injection according to the following method. 1. KSD-201 treatment dose: The provisional dosing is set at 5.0 × 10\^6 cells/dose. 2. KSD-201 treatment frequency: a total of 3-5 times. The 4th and 5th times are booster treatments, which need to be decided by the investigator according to the condition of the subjects. 3. Dosing interval: 2 weeks. The interval may be adjusted based on the subject's condition during the intensive treatment phase. 4. KSD-201 route of administration: subcutaneous injection. 5. Administration site: near the axillary lymph node or inguinal lymph node.

Conditions

• Clear Cell Renal Cell Carcinoma (ccRCC)

Interventions

Type	Name	Description
BIOLOGICAL	KSD-201	Patients will receive approximately 5x10\^6 cells/dose DC vaccine via subcutaneous injections bi-weekly,total 3-5 times.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-11-30
• Completion: 2027-11-30
• First posted: 2024-11-29
• Last updated: 2025-09-03

Locations

1 site across 1 country: China