Overview
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
Key-Inclusion Criteria:
- ≥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
Key-Exclusion Criteria:
- 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