mRNA therapy that makes a CD19/CD3 T-cell engager (ABO2203) for relapsed or refractory B-cell non-Hodgkin lymphoma.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GI001 CAR-T for relapsed or refractory B-cell NHL and B-ALL

  This treatment study tests GI001, an in vivo CAR-T therapy, to see if it is safe and helpful for adults with relapsed or refractory B-cell NHL or B-ALL.

  Recruiting Early Phase 1 Hematology department of the 920th hospital · Yunnan, Kunming · NCT07862010

• ARC-02 with Rituximab for B-cell non-Hodgkin lymphomas

  This study tests ARC-02, together with Rituximab, to see if the treatment is safe and shows early signs of activity in people with B-cell non-Hodgkin lymphomas who have already tried multiple therapies.

  Recruiting at 3 sites Phase 1 Taiho Oncology, Inc. · Los Angeles, California and 27 other locations · NCT07691606

• SHR-3079 in B-cell non-Hodgkin lymphoma

  This small early study tests SHR-3079 in adults with B-cell non-Hodgkin lymphoma to see if it is safe and tolerable and to find a workable dose for future testing.

  Recruiting at 2 sites Phase 1 Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Beijing, Beijing Municipality and 1 other locations · NCT07661537

• Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL

  This trial tests whether giving allogeneic NK cells with Rituximab, Tafasitamab, and IL-2 can help people with relapsed or refractory B-cell non-Hodgkin lymphoma who have tried at least two prior therapies.

  Recruiting Phase 1 Case Comprehensive Cancer Center · Cleveland, Ohio and 1 other locations · NCT07225439

• First-in-human test of DS3790a for hematological malignancies

  This first-in-human trial will test DS3790a alone and with other drugs to see if it's safe, how it behaves in the body, and whether it helps adults with hematological malignancies.

  Recruiting at 8 sites Phase 1/2 Daiichi Sankyo · New York, New York and 7 other locations · NCT07220616

• AZD4512 alone or with other medicines for relapsed or refractory B‑cell non‑Hodgkin lymphoma

  This trial will try AZD4512 by itself or with other cancer drugs to see if it helps adults whose B‑cell non‑Hodgkin lymphoma has relapsed or not responded after prior treatments.

  Recruiting at 16 sites Phase 1/2 AstraZeneca · Irvine, California and 22 other locations · NCT07123454

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.