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RECRUITINGPhase 1INTERVENTIONAL

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

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: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Key-Who May Qualify: - ≥18 years and ≤75 years of age at time of willing to sign a consent form - 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-Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)s - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

ABO2203 Injection

SC or IV

Locations (1)

Ruijin Hospital
Shanghai, Shanghai Municipality, China