Clear Cell Renal Cell Carcinoma (ccRCC)Early Phase 1NCT06708936
KSD-201 Treatment for Advanced Clear Cell Renal Cell Carcinoma: an Early Exploratory Clinical Study
A Early Phase 1 study testing KSD-201 in people with Clear Cell Renal Cell Carcinoma (ccRCC), run by Kousai Bio Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma (ccRCC)
- What is being tested?
- KSD-201
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 17 Mar 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
Official title: 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
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.
Read the 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.
- KSD-201 treatment dose: The provisional dosing is set at 5.0 × 10^6 cells/dose.
- 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.
- Dosing interval: 2 weeks. The interval may be adjusted based on the subject's condition during the intensive treatment phase.
- KSD-201 route of administration: subcutaneous injection.
- Administration site: near the axillary lymph node or inguinal lymph node.
- Conditions
- Clear Cell Renal Cell Carcinoma (ccRCC)
- Being tested
- KSD-201
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSD-201Biological
Patients will receive approximately 5x10^6 cells/dose DC vaccine via subcutaneous injections bi-weekly,total 3-5 times.
| Study group | Role | What they receive |
|---|---|---|
| KSD-201 | Experimental | Biological: Dendritic Cell Vaccine.Autologous monocyte-derived DCs pulsed with clear cell renal cell carcinoma-associated antigen. Receives: Biological: KSD-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Incidence and number of dose-limiting toxicities
Measured: From the infusion (Day 0) to Day 28
Safety endpoint
Adverse events will be graded according to the NCI-CTCAE 5.0 grading criteria throughout the study period, except for injection site (localized) adverse events, which will be graded with reference to the Guidelines for Grading Criteria for Adverse Events in Clinical Trials of Vaccines for Prophylaxis. Monitor and assess the incidence and relevance to study drug and severity of all adverse events, vital signs, physical examination and laboratory findings.
Measured: 1 year after DC Vaccines injection
Secondary outcomes (8)
Objective response rate (ORR)
The percentage of participants who achieved PR or better response
Measured: 1 year after DC Vaccines injection
Disease control rate (DCR)
The percentage of participants who achieved SD or better response
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year after DC Vaccines injection
Levels of various lymphocyte subsets
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
Measured: 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
Measured: 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
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Mar 2026
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Why it stopped: Due to a strategic adjustment, the company has decided to terminate the project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell Carcinoma (ccRCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kousai Bio Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708936
- Sponsor's protocol ID
- KSD-201-CR001
- Status last verified
- May 2026
- First submitted
- 25 Nov 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06708936
- Acronym / sponsor ID
- KSD-201-CR001
- Conditions
- Clear Cell Renal Cell Carcinoma (ccRCC)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to a strategic adjustment, the company has decided to terminate the project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kousai Bio Co., Ltd.University, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- KSD-201 treatment dose: The provisional dosing is set at 5.0 × 10^6 cells/dose.
- 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.
- Dosing interval: 2 weeks. The interval may be adjusted based on the subject's condition during the intensive treatment phase.
- KSD-201 route of administration: subcutaneous injection.
- Administration site: near the axillary lymph node or inguinal lymph node.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KSD-201 | Experimental | Biological: KSD-201Biological: Dendritic Cell Vaccine.Autologous monocyte-derived DCs pulsed with clear cell renal cell carcinoma-associated antigen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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：
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KSD-201Patients will receive approximately 5x10^6 cells/dose DC vaccine via subcutaneous injections bi-weekly,total 3-5 times. | Biological | KSD-201 |
Primary outcome
DLT
Time frame: From the infusion (Day 0) to Day 28
Incidence and number of dose-limiting toxicities
Safety endpoint
Time frame: 1 year after DC Vaccines injection
Adverse events will be graded according to the NCI-CTCAE 5.0 grading criteria throughout the study period, except for injection site (localized) adverse events, which will be graded with reference to the Guidelines for Grading Criteria for Adverse Events in Clinical Trials of Vaccines for Prophylaxis. Monitor and assess the incidence and relevance to study drug and severity of all adverse events, vital signs, physical examination and laboratory findings.
8 secondary outcomes
Objective response rate (ORR)
Time frame: 1 year after DC Vaccines injection
Disease control rate (DCR)
Time frame: 1 year after DC Vaccines injection
Duration of response (DOR)
Time frame: 1 year after DC Vaccines injection
Progression-free survival (PFS)
Time frame: 1 year after DC Vaccines injection
Overall survival (OS)
Time frame: 1 year after DC Vaccines injection
Levels of various lymphocyte subsets
Time frame: 1 year after DC Vaccines injection
EQ-5D-5L
Time frame: Up to 1 year
QLQ-C30
Time frame: Up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing KSD-201 in people with Clear Cell Renal Cell Carcinoma (ccRCC), run by Kousai Bio Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: From the infusion (Day 0) to Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.