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
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