mRNA therapy that makes a CD19/CD3 T-cell engager (ABO2203) for relapsed or refractory B-cell non-Hodgkin lymphoma.
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
This will try an mRNA drug (ABO2203) that makes immune-engaging CD19/CD3 proteins to see if it is safe and helps adults with relapsed or refractory CD19-positive B-cell non-Hodgkin lymphoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07072169 on ClinicalTrials.gov |
What this trial studies
This phase 1, first-in-human program delivers mRNA encoding a CD19/CD3 T-cell engager (ABO2203) by injection to adults with relapsed or refractory CD19-positive B-cell non-Hodgkin lymphoma. The study includes a dose-escalation portion to identify a tolerable dose and a dose-expansion portion to gather additional safety and activity data. Key measurements include safety and tolerability, pharmacokinetics and pharmacodynamics, and preliminary anti-tumor activity using Lugano 2014 response criteria. The trial is conducted at Ruijin Hospital in Shanghai.
Who should consider this trial
Good fit: Adults aged 18–75 with histologically confirmed relapsed or refractory CD19-positive B-cell non-Hodgkin lymphoma, at least one measurable lesion by Lugano 2014, ECOG 0–2, and adequate organ function are the intended participants.
Not a fit: Patients with central nervous system lymphoma, prior allogeneic stem cell or organ transplants, active autoimmune disease, significant pulmonary disease, recent other active malignancy, uncontrolled comorbidities, or CD19-negative tumors are excluded or unlikely to benefit.
Why it matters
Potential benefit: If successful, ABO2203 could provide a new non-cellular immunotherapy that recruits patients' own T cells to target CD19-positive lymphoma, potentially producing remissions in people who have relapsed after prior treatments.
How similar studies have performed: CD19/CD3 bispecific T-cell engagers have shown clinical activity in B-cell malignancies, but delivering such engagers via mRNA (as ABO2203) is a novel approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Wei li Zhao — Ruijin Hospital
- Study coordinator: Pei miao Zhang
- Email: pm.zhang@wiseon.cn
- Phone: 010-57593072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.