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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Patients will receive approximately 5x10\^6 cells/dose DC vaccine via subcutaneous injections bi-weekly,total 3-5 times.
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
DLT
Incidence and number of dose-limiting toxicities
Time frame: From the infusion (Day 0) to Day 28
Safety
Incidence and severity of AEs, including vital signs, physical examination, and laboratory tests
Time frame: 1 year after DC Vaccines injection
Objective response rate (ORR)
The percentage of participants who achieved PR or better response
Time frame: 1 year after DC Vaccines injection
Disease control rate (DCR)
The percentage of participants who achieved SD or better response
Time frame: 1 year after DC Vaccines injection
Duration of response (DOR)
DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease
Time frame: 1 year after DC Vaccines injection
Progression-free survival (PFS)
The time from the start of CAR-GPRC5D treatment for the participants to the first time of disease progression or death for any reason
Time frame: 1 year after DC Vaccines injection
Overall survival (OS)
OS is measured from the date of the initial injection of DC Vaccines to the date of the participant's death
Time frame: 1 year after DC Vaccines injection
Levels of various lymphocyte subsets
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total T lymphocytes, activated T lymphocytes, helper T lymphocytes, cytotoxic T lymphocytes, regulatory T lymphocytes, total B lymphocytes and total NK cells in peripheral blood will be assessed to monitor changes
Time frame: 1 year after DC Vaccines injection
EQ-5D-5L
The change from baseline in scores of EQ-5D-5L endpoints will be analyzed by age group or indication group
Time frame: Up to 1 year
QLQ-C30
The change from baseline in scores of QLQ-C30 endpoints will be analyzed by age group or indication group
Time frame: Up to 1 year