Actively Recruiting
A Single-arm, Open-label Exploratory Study of IASO208 Injection for Relapsed or Refractory B-cell Malignancies
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-06-01
12
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
S
Shanghai IASO Biotechnology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating IASO208 injection, a gene therapy drug, in adults with relapsed or refractory B-cell malignancies, including various types of lymphoma. This early phase, single-arm, open-label study aims to assess the safety, how the drug moves through the body, and preliminary effectiveness in patients whose disease has returned or not responded to standard treatments. The study uses a dose-escalation design with seven different dose groups ranging from 1E8 TU to 1.8E9 TU. IASO208 is administered as an injection and is a third-generation lentiviral vector gene therapy. Participants receive this treatment in a single arm without comparison groups. Participants will be monitored for up to two years after dosing. Assessments include checking for dose-limiting toxicities within 28 days and adverse events and laboratory abnormalities over two years. Researchers will also measure responses to treatment, survival outcomes, and various blood markers, including viral particle levels and immune cell counts, at multiple time points to evaluate the treatment's effects and safety.
CONDITIONS
Brief Title
IASO208 Injection in the Treatment of Relapsed/Refractory B-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years
- Voluntarily agree to participate and sign informed consent
- Histopathological diagnosis of specific B-cell lymphomas including DLBCL, HGBL, Grade 3b Follicular Lymphoma, transformed DLBCL, PMBCL, or Mantle cell lymphoma
- Relapsed or refractory disease after standard treatment as assessed by investigator
- CD20 positivity confirmed on tumor biopsy after last relapse or during screening
- At least one measurable lesion per Lugano 2014 criteria
- ECOG Performance Status of 0 to 2
- Life expectancy of at least 12 weeks
- Adequate organ function based on specific laboratory results
- Agreement to use effective contraception if of childbearing potential from consent until 1 year after last dose
You will not qualify if you...
- Central nervous system involvement
- Other malignancies within 5 years except certain treated cancers
- Positive for hepatitis B, hepatitis C, HIV, syphilis, or active CMV infection with abnormal tests
- Uncontrolled active infections requiring intravenous therapy or not improving
- Severe cardiac diseases including recent myocardial infarction, unstable angina, severe heart failure, or severe arrhythmia
- History of central nervous system diseases or disorders within 6 months
- Previous solid organ transplantation
- Previous allogeneic stem cell transplantation or allogeneic CAR-T or donor cell therapies
- Recent cytotoxic chemotherapy, immunosuppressive therapy, radiotherapy, major surgery, vaccination, or investigational treatments within defined washout periods
- Presence of unstable systemic diseases requiring treatment
- Unresolved adverse events from prior anti-tumor therapies above grade 2 except certain conditions
- Known hypersensitivity to IASO208 components
- Pregnant or lactating women
- Any other condition deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days from dosing
Participants receive IASO208 injection, a gene therapy for relapsed or refractory B-cell malignancies, in one of seven dose groups.
1 dosing visit and multiple follow-up visits during initial 28 days
Duration - Up to 2 years from dosing
Participants are monitored for adverse events, response to treatment, and laboratory parameters for up to 2 years after dosing.
Regular visits over 2 years for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
H
Heng Mei
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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