RecruitingPhase 1NCT07072169
A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)
A Clinical Study to Investigate Safety, Tolerability, and Preliminary Efficacy of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Adult Patients With Relapsed or Refractory B-NHL
Sponsor
Ruijin Hospital
Enrollment
56 participants
Start Date
May 26, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, as well as preliminary efficacy of mRNA encoding CD19/CD3 T cell engager (ABO2203) in adult patients with relapsed or refractory CD19-positive B-NHL, This study included dose escalation and dose expansion parts.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria6
- ≥18 years and ≤75 years of age at time of informed consent
- Participants with histologically and/or cytologically confirmed relapsed or refractory CD19-positive B-cell non-Hodgkin lymphoma
- With at least one of evaluable/measurable target lesions per Lugano 2014 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
- Life expectancy of ≥3 months
- Sufficient organ function
Exclusion Criteria8
- Central nervous system lymphoma
- Previously undergone allogeneic hematopoietic stem cell transplantation or other organ transplants
- Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that has been cured, or carcinoma in situ of the cervix
- History of active autoimmune diseases
- History of interstitial lung disease, tuberculosis, or other diseases that affect pulmonary function in the past or currently
- Uncontrolled disease, including but not limited to uncontrolled diabetes, hypertension, active infections, active peptic ulcers, thromboembolic disease requiring anticoagulation, etc.
- Severe cardiovascular diseases
- History of severe allergies to protein-based drugs or any component of the study drug
Interventions
DRUGABO2203 Injection
SC or IV
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07072169
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