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.
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;
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;
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 situ after radical surgery, or thyroid cancer after radical surgery;
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 enrollment (including fungal, bacterial, viral, or other infections);
Single group
Anti-Human CD70 T-Cell Injection
DrugAutologous genetically modified anti-Human CD70 CAR transduced T cells
Dose limited toxicity (DLT)
Number of subjects with adverse event
adverse event is any untoward medical event that occurs in a subject administered an investigational drug
Change from baseline in perform status as measured by Eastern Cooperative Oncology Group (ECOG) performance status score
Eastern Cooperative Oncology Group (ECOG) performance status score will be assessed by the investigator at each designated time point. The ECOG performance status Score ranges from 0 to 5, where 0 indicates fully active with no restriction, and 5 indicates death. Higher scores indicate worse functional status and greater disease burden.
Number of participants with clinically significant changes from baseline in laboratory parameters
Laboratory assessments include complete blood count (CBC) with differential (e.g., white blood cell \[WBC\] count, hemoglobin \[Hgb\], and platelet count), serum chemistry panel (e.g., serum creatinine \[SCr\], alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and total bilirubin \[TBIL\]), and coagulation parameters (e.g., prothrombin time \[PT\] and activated partial thromboplastin time \[aPTT\]). Clinically significant abnormalities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. Changes from baseline will be summarized descriptively by visit and toxicity grade.
Number of participants with clinically significant changes from baseline in physical examination findings
Physical examinations will include assessment of general appearance, vital signs (blood pressure \[BP\], heart rate \[HR\], respiratory rate \[RR\], and body temperature), body weight, and organ system review (e.g., cardiovascular, respiratory, abdominal, neurological). Clinically significant changes from baseline will be identified by the investigator and recorded as adverse events (AEs), graded per NCI CTCAE v5.0.
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Hrain Biotechnology Co., Ltd.
Lead sponsor
RenJi Hospital
Collaborator
