CD70-Targeted CAR-T Therapy in CD70-Positive Advanced Solid Tumors
Trial Parameters
Brief Summary
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CD70-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CD70-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CD70-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years, regardless of gender; 2. Histologically or cytologically confirmed advanced/metastatic solid tumors (tumors with positive CD70 expression, confirmed histopathological ly with IHC 3+ score); 3. Failed or intolerant to standard second-line treatments (at least one of the following: tyrosine kinase inhibitors (TKIs), poly(ADP-ribose) polymerase inhibitors (PARPi), anti-angiogenic therapy; disease progression or inability to tolerate surgery, chemotherapy, radiotherapy, or targeted therapy); 4. At least one measurable lesion per RECIST 1.1 criteria, with measurable lesions defined as: 1. Extranodal lesions with a long axis ≥10mm on CT scan; 2. Lymph node lesions with a short axis ≥15mm on CT scan; 3. CT slice thickness ≤5mm. 5. ECOG performance status of 0-2 ; 6. Expected survival ≥12 weeks; 7. No history of severe psychiatric disorders; 8. Adequate organ function as defined by the following: 1. Hematology: White blood cell count \>2.0×10⁹/L, neutrophi