IASO208 Injection in the Treatment of Relapsed/Refractory B-cell Malignancies
Trial Parameters
Brief Summary
This is an investigator-initiated, single-arm, open-label clinical study. It employs a dose-escalation design to evaluate the safety, pharmacokinetics, and preliminary efficacy of IASO208 injection in relapsed/refractory B-cell malignancies.
Eligibility Criteria
Inclusion Criteria Subjects must meet all of the following criteria to be enrolled in this study: 1. Aged ≥18 years and ≤75 years. 2. Voluntary participation in this study and signing the informed consent form. 3. Prior histopathological biopsy confirming a diagnosis of one of the following pathological types: * Diffuse Large B-Cell Lymphoma (DLBCL), including High-Grade B-Cell Lymphoma (HGBL); * Grade 3b Follicular Lymphoma (FL3b); * DLBCL transformed from indolent lymphoma (FL or MZL); * Primary Mediastinal Large B-Cell Lymphoma (PMBCL). 4. For B-cell lymphoma patients with relapsed/refractory diseases who have failed standard treatment (including relapse, non-remission, and progression), they must have received prior standard immunochemotherapy containing an anti-CD20 monoclonal antibody and an anthracycline-based regimen: * Relapsed disease is defined as disease relapse or progression occurring ≥12 months after the end of prior therapy. * Refractory disease is defined as disease pr