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.
Aged ≥18 years and ≤75 years.
Voluntary participation in this study and signing the informed consent form.
Diffuse Large B-Cell Lymphoma (DLBCL), including High-Grade B-Cell Lymphoma (HGBL);
Grade 3b Follicular Lymphoma (FL3b);
Subjects with central nervous system involvement.
Subjects who have had other malignancies within 5 years prior to screening, except for appropriately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ of the breast, or papillary thyroid carcinoma.
Subjects positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with abnormal peripheral blood HBV DNA test (abnormal HBV DNA is defined as: quantitative detection higher than the lower limit of detection [LLD], above the normal range, or positive qualitative detection).
Subjects positive for hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Shanghai IASO Biotechnology Co., Ltd
Collaborator