Kidney cancer vaccine trial pulled before it began
NCT ID NCT06708936
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase study aimed to test a new vaccine called KSD-201 in people with advanced clear cell renal cell carcinoma whose cancer had stopped responding to standard treatments. The vaccine uses the patient's own immune cells to try to fight the cancer. However, the trial was withdrawn before any participants were enrolled, so no data on safety or effectiveness were collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KSD-201 (dendritic cell vaccine)
- What this could lead to
- If it works, this could point toward a new vaccine-based treatment for advanced kidney cancer that has stopped responding to standard therapy.
- What could go wrong
- This trial was withdrawn before enrolling any participants, so no results are available. It was an early-phase study with a small planned sample, so even if conducted, success would be uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Started
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Mar 2026
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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. 9\. 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. Exclusion Criteria: * 1\. 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. 2\. 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. 5\. Underwent therapeutic surgery within 4 weeks prior to enrollment, or plan to undergo major surgery during the study, except diagnostic, biopsy and drainage procedures. 6\. Presence of uncontrolled infectious disease within 4 weeks prior to enrollment. 7\. 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. 8\. Active central nervous system metastases/lesions (e.g., brain edema requiring hormone intervention or brain metastases). 9\. 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. 10\. 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. 11\. 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). 12\. 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. 13\. 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. 17\. Other conditions that render a subject unsuitable for enrollment as judged by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a single injection reveal hidden kidney cancer?
- Cell therapy combo aims to boost kidney cancer treatment
- New drug duo aims to shrink advanced kidney tumors