B-cell Non-Hodgkin Lymphoma
Conditions
Keywords
mRNA, CD19/CD3, T cell engager, B-NHL
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.
Interventions
SC or IV
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A study of mRNA encoding CD19/CD3 T cell engager (ABO2203) in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) | From the first dose to 30 days after the last dose of ABO2203 treatment | The incidence and severity of adverse events evaluated by Common Terminology Criteria for Adverse Events (CTCAE) |
Countries
China
Contacts
Primary ContactPei miao Zhang
Outcome results
None listed