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.
Single group
IASO208 injection
GeneticIASO208 injection is a third-generation, self-inactivated, replication-deficient Lentiviral Vector (LVV) gene therapy research drug.
The incidence of dose-limiting toxicity (DLT);
Percentage of participants who experienced DLT within 28 days after IASO208 administration.
The incidence and severity of adverse events (AEs)
Percentage of participants who experienced AEs after IASO208 administration and severity was graded according to the NCI-CTCAE version 5.0.
The types、incidence and severity of abnormal laboratory tests;
The types、incidence and severity of abnormal laboratory results assessed by CTCAEV5.0 will be analyzed and reported.
Objective response rate (ORR)
ORR was defined as the percentage of participants who achieved partial response (PR) or better as assessed by the investigator according to the Lugano 2014 Criteria.
Objective response rate (ORR) at pre-specified timepoints
ORR at 3, 6, 12 months as assessed by the investigator according to the Lugano 2014 Criteria.
Complete response rate (CRR)
CRR was defined as the percentage of participants who achieved complete response (CR) as assessed by the investigator according to the Lugano 2014 Criteria.
Duration of Response (DOR)
DOR was defined as the time (in months) from the date of initial documented response (PR or better response) to the date of first documented evidence of progressive disease (PD) or death.
Percentage of participants with positive anti-drug antibodies (ADA)
Percentage of participants with positive antibodies will be reported.
Percentage of participants with Replication-Competent Lentivirus (RCL)
Percentage of participants with RCL will be reported.
Percentage of participants with detectable viral particles in secretions following IASO208 administration.
Percentage of participants with detectable viral particles in secretions will be reported.
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Shanghai IASO Biotechnology Co., Ltd
Collaborator
