Actively Recruiting
IASO208 Injection in the Treatment of Relapsed/Refractory B-cell Malignancies
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-01-12
12
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
N
Nanjing IASO Biotechnology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IASO208 Injection in the Treatment of Relapsed/Refractory B-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years to 75 years
- Voluntarily agree to participate and sign informed consent
- Histopathological diagnosis of one of: 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)
- Relapsed or refractory B-cell lymphoma after standard treatment including anti-CD20 monoclonal antibody and anthracycline-based regimen
- CD20 positivity confirmed on tumor biopsy after last relapse or during screening
- At least one measurable lesion per Lugano 2014 criteria
- ECOG Performance Status 0-2
- Life expectancy of at least 12 weeks
- Adequate organ function based on defined hematology, liver, cardiac, oxygen saturation, renal, and coagulation criteria
- Use of effective contraception from consent until at least 1 year after last dose if of childbearing potential
You will not qualify if you...
- Central nervous system involvement
- Other malignancies within 5 years prior to screening except certain treated cancers
- Positive for hepatitis B with abnormal HBV DNA, hepatitis C with positive RNA, HIV antibody positive, syphilis, or active cytomegalovirus infection
- Uncontrolled active bacterial, fungal, or viral infection needing intravenous therapy or not improving after treatment
- Severe cardiac diseases including unstable angina, recent myocardial infarction, severe heart failure, or severe arrhythmia
- History of central nervous system diseases or disorders within 6 months prior to screening
- Prior solid organ transplantation
- Prior allogeneic hematopoietic stem cell transplantation, allogeneic CAR-T therapy, or other allogeneic donor cell therapies
- Not meeting required washout periods from previous therapies including cytotoxic chemotherapy, immunotherapies, corticosteroids, radiotherapy, surgery, vaccinations, or investigational treatments
- Presence of other unstable systemic diseases requiring treatment
- Unresolved adverse events from previous anti-tumor therapies above Grade 2 except alopecia, fatigue, and peripheral neuropathy
- Known hypersensitivity to IASO208 injection components
- Pregnant or lactating women
- Any other condition judged inappropriate by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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