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 | Recruiting Phase 1

• 1 other identifier: ABO2203-003
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

B-cell Non-Hodgkin Lymphoma

Keywords

mRNA, CD19/CD3, T cell engager, B-NHL

Outcome Measures

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)

  The incidence and severity of adverse events evaluated by Common Terminology Criteria for Adverse Events (CTCAE)

  From the first dose to 30 days after the last dose of ABO2203 treatment

Study Arms (1)

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

EXPERIMENTAL

ABO2203

Drug: ABO2203 Injection

Interventions

ABO2203 Injection DRUG

SC or IV

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Wei li Zhao

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei miao Zhang

CONTACT

010-57593072; pm.zhang@wiseon.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: July 18, 2025
• Study Start: May 26, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-05

Locations

CN (1)