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

NCT06708936 | Not Yet Recruiting Early Phase 1

• 1 other identifier: KSD-201-CR001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clear Cell Renal Cell Carcinoma (ccRCC)

Outcome Measures

Primary Outcomes (2)

• DLT

  Incidence and number of dose-limiting toxicities

  From the infusion (Day 0) to Day 28

• Safety

  Incidence and severity of AEs, including vital signs, physical examination, and laboratory tests

  1 year after DC Vaccines injection

Secondary Outcomes (8)

• Objective response rate (ORR)

  1 year after DC Vaccines injection

• Disease control rate (DCR)

  1 year after DC Vaccines injection

• Duration of response (DOR)

  1 year after DC Vaccines injection

• Progression-free survival (PFS)

  1 year after DC Vaccines injection

• Overall survival (OS)

  1 year after DC Vaccines injection

Study Arms (1)

KSD-201

EXPERIMENTAL

Biological: Dendritic Cell Vaccine.Autologous monocyte-derived DCs pulsed with clear cell renal cell carcinoma-associated antigen.

Biological: KSD-201

Interventions

KSD-201 BIOLOGICAL

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

KSD-201

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. According to RECIST v1.1 criteria, there should be at least one measurable lesion.
• \. Eastern Cooperative Oncology Group (ECOG) score of 0-1. 6. Eligible for leukapheresis and has no other contraindications for cell collection.
• \. 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 function: Creatinine ≤ 1.5 × ULN
• Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%
• pulmonary function：Pulse oximetry saturation ≥ 94%.
• Coagulation function: Fibrinogen ≥ 1.0 g/L, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN 8. Patient's corresponding lymph node regions meet the requirements for subcutaneous injection.
• \. Male and female subjects of reproductive age agree to take non-pharmacological contraceptive measures from signing the ICF until 6 months after the last dose.

You may not qualify if:

• \. Within 4 weeks prior to apheresis, patients have received any chemotherapy, immunosuppressive drugs, or other medicinal treatments, or have undergone less than 5 drug half-lives (whichever is shorter), and within 2 weeks prior to apheresis, they have undergone systemic radiation therapy.
• \. Underwent allogeneic transplantation prior to enrollment. 3. Received (attenuated) live vaccines within 4 weeks prior to enrollment. 4. Participated in other clinical studies within 4 weeks prior to enrollment and received at least one dose of the investigational product.
• \. Underwent therapeutic surgery within 4 weeks prior to enrollment, or plan to undergo major surgery during the study, except diagnostic, biopsy and drainage procedures.
• \. Presence of uncontrolled infectious disease within 4 weeks prior to enrollment.
• \. Receiving systemic corticosteroid therapy prior to screening and require long-term systemic corticosteroids during the treatment period (except inhalation or topical application) as judged by the investigator, or received systemic corticosteroid therapy (except inhalation or topical application) within 72 hours prior to administration.
• \. Active central nervous system metastases/lesions (e.g., brain edema requiring hormone intervention or brain metastases).
• \. Severe cardiovascular diseases:
• Grade ≥ 3 cardiovascular diseases according to the New York Heart Association (NYHA) classification within 6 months prior to enrollment.
• Unstable angina or severe arrhythmias requiring medication.
• Other significant ECG abnormalities, including second-degree type 2 atrioventricular block, third-degree atrioventricular block, bradycardia (ventricular rate \< 50 beats/min with clinical symptoms), etc.
• \. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and increased peripheral blood hepatitis B virus (HBV) DNA titer above the ULN; positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis-specific antibodies.
• \. Have not recovered to normal or Grade ≤ 1 from prior treatment-induced AEs prior to enrollment, except alopecia (any grade) and peripheral neuropathy (Grade ≤ 2).
• \. Other active malignancies within the past 3 years, except for curable cancers that have been markedly cured, such as basal or squamous cell carcinoma, cervical or breast cancer in situ.
• \. Prior history of severe drug allergies or history of penicillin allergy. 14. Substance abuse/addiction. 15. Women who are pregnant or nursing. 16. Other serious medical conditions, including liver disease, kidney disease, neurological/psychiatric disorders, endocrine disorders, hematologic disorders, and immune system disorders, which will render a subject unsuitable for participation in the study as judged by the investigator.
• \. Other conditions that render a subject unsuitable for enrollment as judged by the investigator.

Sponsors & Collaborators

• Kousai Bio Co., Ltd.: lead

Study Sites (1)

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: September 3, 2025

Record last verified: 2024-11

Locations

CN (1)