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Tests treatment safety and results for Renal Cell Carcinoma (RCC)
Official title To Evaluate the Safety and Tolerability of Anti-Human CD70 T-Cell Injection in Subjects With Advanced/Metastatic Renal Cancer
ClinicalTrials.gov ID: NCT07647744
What this study is testing
What is Anti-Human CD70 T-Cell Injection?
Anti-Human CD70 T-Cell Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for renal cell carcinoma (rcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-arm, open-label, dose-escalating Phase 1 clinical study. It aims to evaluate the safety, tolerability and pharmacokinetic(PK) profiles of the investigational agent, and preliminarily assess its efficacy in subjects with advanced/metastatic renal cell carcinoma, and determine the recommended dose and infusion regimen for Phase 2 trials.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age 18 to 70 years (inclusive), regardless of gender;
- Life expectancy of more than 12 weeks;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1;
- people with advanced/metastatic renal cell carcinoma (RCC):
- Histologically confirmed clear cell renal cell carcinoma (ccRCC), with an International Metastatic RCC Database Consortium (IMDC) risk stratification...
You likely can't join if
- Prior treatment with anti-CD70 targeted therapies;
- Brain metastasis from renal cell carcinoma;
- Concomitant with other uncontrolled malignancies, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer...
- Any uncontrolled active infection, including but not limited to active tuberculosis; presence or suspicion of an uncontrolled infection, or an...
- people who are hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, with peripheral blood HBV DNA titers above...
- Any unstable systemic disease, including but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack within 6 months...
See the full eligibility criteria
- Age 18 to 70 years (inclusive), regardless of gender;
- Life expectancy of more than 12 weeks;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1;
- people with advanced/metastatic renal cell carcinoma (RCC):
- Histologically confirmed clear cell renal cell carcinoma (ccRCC), with an International Metastatic RCC Database Consortium (IMDC) risk stratification of intermediate or high risk as evaluated by the investigator;
- Has at least one measurable lesion according to RECIST 1.1;
- Tumor tissue samples must test positive for CD70 expression via immunohistochemistry (IHC);
- Must have received at least one prior line of systemic therapy (must include at least: (1) immuno-oncology (IO) combination therapy: concomitant targeting of PD-1 and CTLA-4, or (2) an immune checkpoint inhibitor...
- Venous access required for apheresis can be established; hemoglobin ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5×10\^9/L, and platelet count ≥ 100× 10\^9/L, and the leukepheresis can be carried according to the...
- Hepatic, renal, cardiac, and pulmonary functions must meet the following criteria:
- Creatinine clearance (CrCl) ≥ 50 mL/min (calculated by the Cockcroft-Gault formula);
- Left ventricular ejection fraction (LVEF) \> 50%;
- Baseline peripheral oxygen saturation \> 95%;
- Total bilirubin ≤2 × upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN;
- Voluntary participation in the clinical study: Must understand and be informed about this study, voluntarily sign the Informed Consent Form (ICF), and be willing to complete all study procedures.
- Prior treatment with anti-CD70 targeted therapies;
- Brain metastasis from renal cell carcinoma;
- Concomitant with other uncontrolled malignancies, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in...
- Any uncontrolled active infection, including but not limited to active tuberculosis; presence or suspicion of an uncontrolled infection, or an infection requiring systemic intravenous therapy within 14 days prior to...
- people who are hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, with peripheral blood HBV DNA titers above the lower limit of detection (LLOD) of the study site; those who are...
- Any unstable systemic disease, including but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack within 6 months prior to screening, myocardial infarction within 6 months prior to...
- Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion (except...
- Prior treatment with CAR-T therapy or other genetically modified cell therapies prior to screening;
- History of implantation of a cardiac pacemaker or deep brain stimulator;
- Vaccination with live attenuated vaccines within 4 weeks prior to leukapheresis;
- History of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years that resulted in end-organ damage, or required systemic immunosuppressive therapy or...
- History of central nervous system (CNS) diseases, such as seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or psychiatric disorders; or known active CNS involvement or history...
- people who are receiving systemic steroid therapy prior to screening, and who are judged by the investigator to require long-term use of systemic steroids during the study treatment period (excluding inhaled or topical...
- Presence of medical conditions that interfere with the ability to sign the written Informed Consent Form (ICF) or comply with study procedures; or those who are unwilling or unable to comply with study requirements;
- History of severe immediate hypersensitivity reactions to any of the medications to be used in this study;
- Any other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.