Evaluating a new treatment for B-Cell Non-Hodgkin's Lymphoma

A Phase I/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS303 in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

This study is testing a new treatment called MBS303 to see if it can help people with relapsed or hard-to-treat B-Cell Non-Hodgkin's Lymphoma feel better and respond well to the therapy.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Mabworks Biotech Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Beijing)
• Trial ID: NCT05806099 on ClinicalTrials.gov

What this trial studies

This study is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of MBS303, a novel T-Cell bispecific therapy, in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma. It consists of two parts: a Phase I dose escalation to determine the optimal dosing and a Phase II expansion to further evaluate its effectiveness. Participants will receive MBS303 via intravenous infusion and will be monitored for treatment response and side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with CD20+ B-cell Non-Hodgkin Lymphoma who have relapsed after or failed to respond to at least one anti-CD20 monoclonal antibody treatment.

Not a fit: Patients with chronic lymphoblastic leukemia, Burkitt lymphoma, or those with a history of central nervous system lymphoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with limited treatment alternatives for B-cell Non-Hodgkin's Lymphoma.

How similar studies have performed: While this approach is novel, similar studies targeting B-cell malignancies have shown promising results, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Able and willing to provide written informed consent and to comply with the study protocol.
2. Adult patients, ≥18 years of age;
3. CD20+ B-cell Non-Hodgkin Lymphoma who have relapsed after or failed to respond to at least one prior treatment regimen with an anti-CD20 monoclonal antibody and for whom there is no available therapy expected to improve survival;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
5. Life expectancy ≥3 months;
6. Measurable disease, defined as at lease one bi-dimensionally measurable nodal lesion, defined as \>1.5 cm in its longest dimension, or at least one bi-dimensionally measureable extranodal lesion, defined as \>1.0 cm in its longest dimension
7. Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

1. Chronic lymphoblastic leukemia, Burkitt lymphoma or lymphoplasmacytic lymphom;
2. History of central nervous system (CNS) lymphoma or other CNS disease;
3. Participants with known active infection, including bacterial, viral, parasite, mycobacterial, or other infections (excluding nail bed fungal infections);
4. Surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, tumor embolization, or other antitumor therapy within 28 days prior to the first MBS303;
5. Active or suspected autoimmune diseases;
6. Known severe allergic reaction or/and infusion reaction to monoclonal antibody;
7. Evidence of significant, uncontrolled concomitant disease;
8. Major surgery within 28 days prior to the first MBS303 administration or expected to undergo major surgery during the study treatment;
9. History of another invasive malignant tumors in past 3 years;
10. Participant with history of confirmed progressive multifocal leukoencephalopathy (PML);
11. Severe hemorrhagic diseases such as hemophilia A, hemophilia B, vascular hemophilia, or spontaneous bleeding requiring blood transfusion or other medical intervention;
12. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal HBV DNA or HCV RNA);
13. Pregnant or lactating women; Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) while participating in the study; 2) for at least 12 months after discontinuation of all study treatments.

Where this trial is running

Beijing

• Beijing Cancer Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yuqin Song, Doctor

Conditions Non-Hodgkin's Lymphoma