Evaluating JS203 for patients with relapsed B-cell non-Hodgkin's lymphoma

Phase I Clinical Study of JS203 in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

This study is testing a new drug called JS203 to see if it is safe and effective for people with relapsed B-cell non-Hodgkin's lymphoma.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 219 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05618327 on ClinicalTrials.gov

What this trial studies

This open phase I clinical study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of JS203 in patients suffering from relapsed or refractory B-cell non-Hodgkin's lymphoma. The study is structured into three phases: a dose-escalation phase to determine the optimal dose, a dose-expansion phase to further evaluate safety and efficacy, and an efficacy expansion phase to gather more data on the drug's effectiveness. Participants will receive JS203 for injection and will be closely monitored throughout the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with a confirmed diagnosis of relapsed or refractory B-cell non-Hodgkin's lymphoma expressing the CD20 antigen.

Not a fit: Patients with a history of severe allergic reactions to monoclonal antibody therapies or those who have previously received CD20-CD3 bispecific antibodies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

How similar studies have performed: While this approach is novel, similar studies targeting B-cell non-Hodgkin's lymphoma have shown promise in the past.

Eligibility criteria

Inclusion Criteria:

1. Understand and voluntarily sign the informed consent form.
2. Age 18 - 75 years (both 18 and 75 years), both sexes
3. Expected survival of ≥ 12 weeks.
4. Eastern Collaborative Oncology Group (ECOG) physical status score: 0 to 1.
5. B-cell non-Hodgkin's lymphoma expressing CD20 antigen clearly diagnosed by pathology
6. Patients with non-Hodgkin's lymphoma must have measurable lesions that meet the Lugano 2014 criteria for lymphoma efficacy assessment, requiring lymph node lesions \>1.5 cm in either length or extra-nodal lesions \>1.0 cm in either length.

Exclusion Criteria:

1. history of severe allergy or anaphylactic reaction to monoclonal antibody therapy (or recombinant antibody-associated fusion protein).
2. previous treatment with CD20-CD3 bispecific antibodies.
3. failure to resolve toxicity after prior antitumor therapy, i.e., no return to baseline or grade 0-1 as defined by NCI-CTCAE 5.0 (except for alopecia, hyperpigmentation). Irreversible toxicity that is not reasonably expected to be exacerbated by the study drug and may be enrolled upon confirmation with the sponsor.
4. Received antitumor therapy such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, or biologic therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose. Non-tumor related conditions that are amenable to hormone therapy (e.g. insulin therapy for diabetes and hormone replacement therapy).
5. receive autologous hematopoietic stem cell transplantation within 100 days prior to the first dose
6. have undergone, or are expected to require during the study period, major surgery (as judged by the investigator) or are recovering from surgery within 4 weeks prior to the first dose
7. active hepatitis B or C. Active hepatitis B defined as positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) with HBV DNA above the upper limit of the study center's normal value; active hepatitis C defined as positive for hepatitis C antibody and HCV RNA above the upper limit of the study center's normal value.
8. history of cardiac disease: New York Heart Association (NYHA) \> Class II congestive heart failure, myocardial infarction occurring within 6 months prior to enrollment, or arrhythmia requiring antiarrhythmic therapy and/or left ventricular ejection fraction \< 50%.
9. two or more malignancies within 5 years prior to the first dose. Except for early malignancies that have been eradicated (carcinoma in situ or stage I tumors), such as adequately treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer.
10. persons with uncontrollable psychiatric disorders
11. patients with a history of drug abuse or alcohol abuse
12. other conditions judged by the investigator to be inappropriate for participation in this study, including but not limited to having any disease or medical history that may confound study results and interfere with patient compliance

Where this trial is running

Beijing, Beijing

• Beijing Cancer Hospital — Beijing, Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Yuqin Song, MD — Peking University Cancer Hospital & Institute
• Study coordinator: Zhihao Jiang

Conditions: Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma