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NCT Number: NCT07072169

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

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.

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Key information

Conditions

B-Cell Non-Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Pei miao Zhang

CONTACT

[email protected]

010-57593072

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABO2203 Injection

Drug

SC or IV

Primary outcomes

  1. A study of mRNA encoding CD19/CD3 T cell engager (ABO2203) in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL)

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Pei miao Zhang

CONTACT

[email protected]

010-57593072

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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