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Recruiting Phase 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)

NCT07072169 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2025-05-26
Last updated
2025-07-18

Condition(s) studied

B-cell Non-Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

ABO2203 Injection →

ABO2203 Injection: SC or IV

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
Ruijin Hospital Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07072169 on ClinicalTrials.gov ↗ ← All trials in China