A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ABO2203 Injection.
- Who it may be relevant to
- Registry conditions: B-cell Non-Hodgkin Lymphoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug ABO2203 Injection
SC or IV
Primary outcome measures
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ruijin Hospital — Shanghai
Identifiers
NCT: NCT07072169 · ABO2203-003