OncoMatch/Clinical Trials/NCT05990621
Anti-CD70 CAR-T Cell Injection in Patients With CD70-positive Advanced Urologic Neoplasms
Is NCT05990621 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Anti-CD70 CAR-T cells for cd70-positive advanced urologic neoplasms.
Treatment: Anti-CD70 CAR-T cells — This is a single-arm, open-label, exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of Anti-CD70 CAR-T cell injection in patients with CD70-positive Advanced Urologic Neoplasms.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: CD70 positive (positive)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: targeted therapy — renal cancers
Renal cancers should have failed after targeted therapy and/or immunotherapy.
Must have received: immunotherapy — renal cancers
Renal cancers should have failed after targeted therapy and/or immunotherapy.
Must have received: chemotherapy — urothelial cancers
Urothelial cancers should have failed after chemotherapy and/or immunotherapy.
Must have received: immunotherapy — urothelial cancers
Urothelial cancers should have failed after chemotherapy and/or immunotherapy.
Cannot have received: systemic cytotoxic chemotherapy
Exception: within 4 weeks or 5 half-lives (which is shorter) prior to signing informed consent
Patients have received systemic therapy with cytotoxic chemicals, monoclonal antibodies, or immunotherapy within 4 weeks or 5 half-lives (which is shorter) prior to signing informed consent
Cannot have received: monoclonal antibody
Exception: within 4 weeks or 5 half-lives (which is shorter) prior to signing informed consent
Patients have received systemic therapy with cytotoxic chemicals, monoclonal antibodies, or immunotherapy within 4 weeks or 5 half-lives (which is shorter) prior to signing informed consent
Cannot have received: immunotherapy
Exception: within 4 weeks or 5 half-lives (which is shorter) prior to signing informed consent
Patients have received systemic therapy with cytotoxic chemicals, monoclonal antibodies, or immunotherapy within 4 weeks or 5 half-lives (which is shorter) prior to signing informed consent
Cannot have received: systemic glucocorticoid (prednisone)
Exception: prednisone at a dose of ≥10 mg per day or equivalent within 2 weeks prior to signing informed consent
Patients have received systemic glucocorticoids (prednisone at a dose of ≥10 mg per day or equivalent) or other immune-suppressive therapy within 2 weeks prior to signing informed consent
Cannot have received: immunosuppressive therapy
Exception: within 2 weeks prior to signing informed consent
Patients have received systemic glucocorticoids (prednisone at a dose of ≥10 mg per day or equivalent) or other immune-suppressive therapy within 2 weeks prior to signing informed consent
Cannot have received: biologic agent
Exception: within 1 week or five half-lives (which is shorter) prior to signing informed consent
Patients have received systemic antitumor therapy with a biologic agent or other approved targeted small-molecule inhibitor within 1 week or five half-lives (which is shorter) prior to signing informed consent
Cannot have received: targeted therapy
Exception: within 1 week or five half-lives (which is shorter) prior to signing informed consent
Patients have received systemic antitumor therapy with a biologic agent or other approved targeted small-molecule inhibitor within 1 week or five half-lives (which is shorter) prior to signing informed consent
Cannot have received: Chinese herbal medicine
Exception: with anti-tumor indication within 1 week prior to signing informed consent
Patients have received Chinese herbal medicine or Chinese patent medicine with anti-tumor indication within 1 week prior to signing informed consent
Cannot have received: anti-CD70 CAR-T cell therapy
Patients have received anti-CD70 CAR-T cell therapy
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L (no G-CSF support within 7 days before lab); ALC ≥ 0.5 × 10^9/L; HGB ≥ 80 g/L (no transfusion within 7 days before lab); PLT ≥ 75 × 10^9/L (no transfusion within 7 days before lab).
Kidney function
Serum creatinine (Cr) ≤ 1.5 × ULN; or Estimated glomerular filtration rate (eGFR) ≥30ml/(min·1.73 m2)(Calculated by CKD⁃EPI).
Liver function
AST and ALT ≤ 3.0 × ULN; AST and ALT of patients with liver metastasis ≤ 5 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; TBIL of patients with liver metastasis must ≤ 3.0 × ULN; TBIL of patients with Gilbert's Syndrome ≤ 3.0 × ULN and Direct bilirubin (DBIL) ≤ 1.5 × ULN.
Cardiac function
Left ventricular ejection fraction (LVEF) > 50%
Adequate function defined as: Hematological functions: Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (Patients should not receive G-CSF support within 7 days before laboratory examination); Absolute Lymphocyte Count (ALC) ≥ 0.5 × 10^9/L; Hemoglobin (HGB) ≥ 80 g/L (Patients should not be transfused red cells within 7 days before the laboratory examination); Platelet count (PLT) ≥ 75 × 10^9/L (Patients should not receive transfusion support within 7 days before the laboratory examination). Hepatic functions: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN); AST and ALT of patients with liver metastasis ≤ 5 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; TBIL of patients with liver metastasis must ≤ 3.0 × ULN; TBIL of patients with Gilbert's Syndrome ≤ 3.0 × ULN and Direct bilirubin (DBIL) ≤ 1.5 × ULN. Coagulation functions: International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (Except for patients who are receiving therapeutic anticoagulants.). Renal functions: Serum creatinine (Cr) ≤ 1.5 × ULN; or Estimated glomerular filtration rate (eGFR) ≥30ml/(min·1.73 m2)(Calculated by CKD⁃EPI). Cardiac functions: Left ventricular ejection fraction (LVEF) > 50%; Pulmonary function: Oxygen saturation (SpO2) > 92%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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