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Recruiting Phase 1 NCT06394622

A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors

Trial Parameters

Condition Solid Tumor
Sponsor Fudan University
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 12
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-04-11
Completion 2026-06-28
Interventions
Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells

Brief Summary

This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC729 in the treatment of advanced malignant solid tumors. Condition or disease:advanced malignant solid tumors. Intervention/treatment:Biological: CD70 CAR-NKT cells. Phase:I

Eligibility Criteria

Inclusion Criteria: * Age 18 to 75 years. * ECOG 0-1 points. * The expected survival time is more than 3 months. * Patients with advanced advanced malignant solid tumor confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment. * IHC: CD70 positive. * At least one measurable lesion at baseline per RECIST version 1.1. * The functions of important organs are basically normal:Hematopoietic function: neutrophils 1.5×109/L, platelets 75×109/L, hemoglobin 80g/L;Renal function: creatinine clearance of ≥60 mL/min.;Liver function: ALT and AST ≤2.5×ULN (≤5 × ULN for patients with liver metastases);Total bilirubin ≤1.5×ULN.Prothrombin time (PT) : INR \< 1.7. * Pregnancy tests for women of childbearing age shall be negative, Both men and women agreed to use effective contraception. * Subjects or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial a

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