Actively Recruiting
Safety and Efficacy of EX103 in Subjects with Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma
Led by Guangzhou Excelmab Inc. · Updated on 2025-02-27
415
Participants Needed
4
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, single-arm, open, dose-escalation Phase I/II clinical trial, consisting of a dose-escalation phase (accelerated titration phase, 3+3 design) and a dose expansion phase.
CONDITIONS
Official Title
Safety and Efficacy of EX103 in Subjects with Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willingness to comply with study procedures
- Age 18 years or older, any gender
- Dose-escalation phase: confirmed CD20-positive non-Hodgkin lymphoma at first diagnosis (excluding CD20 negative after rituximab), relapsed or refractory after at least 2 prior systemic therapies, no suitable current therapy
- Dose-expansion phase cohorts with specific lymphoma subtypes and treatment history as detailed in protocol
- At least one measurable lesion by CT or MRI (long diameter 2121 1.5 cm for intranodal or 2121 1.0 cm for extranodal)
- ECOG performance status 0-2
- Life expectancy of 12 weeks or more
- Laboratory tests meeting specified blood counts and liver/kidney function thresholds before each cycle
- Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception during treatment and 90 days after
- Negative serum HCG test for women of childbearing age and not breastfeeding
You will not qualify if you...
- History of allergy to study drug or its components
- Uncontrolled active infections at screening
- Previous allogeneic stem cell or organ transplant; autologous stem cell transplant or CAR-T therapy within 3 months
- CNS metastases or serious CNS diseases within 6 months; history of seizure within 12 months
- Active HIV, hepatitis B or C infections as defined by specific test results
- Unresolved toxicities > grade 1 from prior anti-tumor therapy except alopecia
- Other malignancies within 5 years except certain treated skin and cervical cancers
- Use of vaccines within 4 weeks before starting study treatment
- Use of systemic immunosuppressive drugs within 4 weeks prior to study treatment
- History of active autoimmune diseases including myocarditis, lupus, rheumatoid arthritis, and others
- Any condition deemed inappropriate for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Cancer Hospital Affiliated to Zhengzhou University, Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
2
Qilu Hospital, Cheeloo College of Medicine, Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
3
Shanghai Sixth People's Hospital, Shanghai Jiaotong University school of Medicine
Shanghai, Shanghai Municipality, China, 200233
Actively Recruiting
4
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
J
Jiali Lu, MD, PHD
CONTACT
Y
Yanfei Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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