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

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 1

Conditions: B-cell Non-Hodgkin Lymphoma

Treatments: Drug: ABO2203 Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07072169

ABO2203-003

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

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

Experimental group

Description:

ABO2203

Treatment:

Drug: ABO2203 Injection