KSD-201 Treatment for Advanced Clear Cell Renal Cell Carcinoma: an Early Exploratory Clinical Study (NCT06708936) | Clinical Trial Compass
WithdrawnEarly Phase 1
KSD-201 Treatment for Advanced Clear Cell Renal Cell Carcinoma: an Early Exploratory Clinical Study
Stopped: Due to a strategic adjustment, the company has decided to terminate the project.
China0Started 2026-03-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 1\. Subjects and/or their legal guardians agree to participate and sign the ICF. 2. Male or female subjects aged 18 years and above on the day of ICF signing. 3. Patients with advanced clear cell renal cell carcinoma, confirmed by pathological tissue examination, who have failed standard therapy (failure of standard therapy refers to disease progression confirmed by imaging during or after at least one systemic regimen, or intolerance to such regimen, which includes tyrosine kinase inhibitors such as sunitinib, axitinib, pazopanib, sorafenib, among others, as well as everolimus and immune checkpoint inhibitors), and for whom no effective treatment measures are available, with the condition posing a serious threat to their lives.
4\. According to RECIST v1.1 criteria, there should be at least one measurable lesion.
5\. Eastern Cooperative Oncology Group (ECOG) score of 0-1. 6. Eligible for leukapheresis and has no other contraindications for cell collection.
7\. Must have adequate organ function:
* Hematology test: Monocyte count ≥ 0.1 × 10\^9/L, neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 90 g/L, platelet count ≥ 100 × 10\^9/L, and no blood transfusion or blood products within 28 days prior to leukapheresis, and no use of hematopoietic growth factors or other drugs to correct blood cells.
* Liver function: ALT, AST ≤ 2.5 × ULN and TBIL ≤ 1.5 × ULN \[for patients with liver metastases: ALT, AST ≤ 5 × ULN and TBIL ≤ 2 × ULN\]
* Kidney fu…