Actively Recruiting
A Clinical Study to Investigate Safety, Tolerability, and Preliminary Efficacy of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Adults With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Led by Ruijin Hospital · Updated on 2025-07-18
56
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and early effectiveness of a new mRNA treatment called ABO2203 that targets CD19/CD3 T cells in adults with relapsed or refractory CD19-positive B-cell Non-Hodgkin Lymphoma (B-NHL). This study includes both a dose escalation phase and a dose expansion phase to explore the treatment's potential and appropriate dosing. Participants will receive ABO2203 either by subcutaneous injection or intravenous infusion. The study is interventional with a single experimental arm where patients are treated with ABO2203. The trial spans from the initial dose through 30 days after the last dose, focusing on evaluating the treatment's effects and behavior in the body. During the study, participants will be closely monitored for safety and response. Researchers will assess the treatment's impact on measurable lymphoma lesions and collect data on how the drug is processed and affects the body. The study requires regular evaluations including physical exams and laboratory tests to ensure participant safety and to measure outcomes. The total age range for participants is 18 to 75 years.
CONDITIONS
Brief Title
A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years and older and up to 75 years of age at time of informed consent
- Histologically and/or cytologically confirmed relapsed or refractory CD19-positive B-cell non-Hodgkin lymphoma
- At least one measurable target lesion according to Lugano 2014 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Life expectancy of at least 3 months
- Sufficient organ function
You will not qualify if you...
- Central nervous system lymphoma
- Previous allogeneic hematopoietic stem cell transplantation or other organ transplants
- Any other active prior malignancy within the last 5 years except cured skin basal cell cancer or carcinoma in situ of the cervix
- History of active autoimmune diseases
- History or current interstitial lung disease, tuberculosis, or other lung diseases affecting pulmonary function
- Uncontrolled diseases such as uncontrolled diabetes, hypertension, active infections, active peptic ulcers, or thromboembolic disease requiring anticoagulation
- Severe cardiovascular diseases
- History of severe allergies to protein-based drugs or any component of the study drug
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 - From the first dose to 30 days after the last dose of ABO2203 treatment
Participants receive ABO2203 injections to treat relapsed or refractory B-cell non-Hodgkin lymphoma.
Visits occur according to treatment schedule until 30 days after the last dose
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
P
Pei miao Zhang
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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