Clinical trial · Interventional
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
NCT07072169CI-TRIAL-00092322recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABO2203 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A study of mRNA encoding CD19/CD3 T cell engager (ABO2203) in patients with relapsed or refractory B
- description
- ABO2203
- interventionNames
- Drug: ABO2203 Injection
Primary outcomes (1)
- measure
- A study of mRNA encoding CD19/CD3 T cell engager (ABO2203) in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL)
- timeFrame
- From the first dose to 30 days after the last dose of ABO2203 treatment
- description
- The incidence and severity of adverse events evaluated by Common Terminology Criteria for Adverse Events (CTCAE)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.