CLEAR CAR-T cell injection (ET-970) is an engineered CD70-targeting allogeneic Chimeric Antigen Receptor T-Cell (CAR-T cell). This is a multi-center, single-arm, open-label, early exploratory clinical study. The objective of this study is to evaluate the safety and preliminary efficacy of ET-970 in unresectable or metastatic clear cell renal cell carcinoma.
Complete blood count (no G-CSF within 1 week prior to blood count testing. or no pegylated G-CSF within 2 weeks prior to blood count testing): Absolute neutrophil count (ANC) ≥ 1.0×10⁹/L. platelet count (PLT) ≥ 100×10⁹/L. hemoglobin ≥ 80 g/L (excluding bone marrow suppression caused by lymphoma involvement of the bone marrow).
Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN, and activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
Liver function: Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3×ULN (if with liver metastasis, AST and ALT ≤ 5×ULN). total bilirubin ≤ 1.5×ULN.
Renal function: Serum creatinine ≤ 1.5×ULN or creatinine clearance (Cockcroft-Gault formula) ≥ 60 mL/min.
Expected survival < 3 months.
Prior or concurrent active malignancy, with the exception of cured or recurrence-free for at least 3 years of cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer, or locally advanced prostate cancer that has received curative treatment, or ductal carcinoma in situ after radical surgery.
Prior use of CD70-targeted therapy.
Previous treatment with CAR-T or any other genetically engineered cell therapy.
Single group
CLEAR CAR-T cell injection
Biological/VaccineCLEAR CAR-T cell injection is an engineered CD70-targeting allogeneic CAR-T cell.
Dose limited toxicity (DLT)
DLT is defined as any of the following adverse events (AEs) related to ET-970 occurring within 28 days after ET-970 infusion (CRS and ICANS will be graded according to the ASTCT 2019 criteria, and other AEs will be evaluated using CTCAE v6.0)
Incidence and severity of AEs and serious adverse events (SAEs)
AEs refer to any adverse medical events occurring in subjects from the initiation of ET-970 administration during clinical trials. SAEs denote events involving death, life-threatening conditions, significant disability/incapacity, hospitalization or prolonged hospitalization arising after ET-970 administration in subjects.
Incidence and severity of AESIs
AESI including grade ≥3 Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and GvHD.
Disease control rate (DCR)
Including complete response (CR), partial response (PR), or stable disease (SD).
Objective Response Rate (ORR)
Including complete response (CR), partial response (PR).
Duration of Response (DOR)
Time from administration to first documented PR or better.
Progression-Free Survival (PFS)
Time from administration to disease progression or death for any cause, whichever occurs first.
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