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

Not Applicable

Recruiting

• Conditions: B-cell Non-Hodgkin Lymphoma
• Interventions: Drug: ABO2203 Injection

• Registration Number: NCT07072169
• Lead Sponsor: Ruijin Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-26
• Study First Submitted: 2025-05-26
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Primary Completion: 2026-06
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A study of mRNA encoding CD19/CD3 T cell engager (ABO2203) in patients with relapsed or refractory B	ABO2203 Injection	ABO2203

Primary Outcome Measures

Name	Time	Method
A study of mRNA encoding CD19/CD3 T cell engager (ABO2203) in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL)	From the first dose to 30 days after the last dose of ABO2203 treatment	The incidence and severity of adverse events evaluated by Common Terminology Criteria for Adverse Events (CTCAE)

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China