A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)

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

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

Conditions2

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