A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL

Last updated: November 19, 2024
Sponsor: Beijing Mabworks Biotech Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Non-hodgkin's Lymphoma

Cancer/tumors

Treatment

MBS303

Clinical Study ID

NCT05806099
MBS303-CT101
  • Ages > 18
  • All Genders

Study Summary

This is a Phase I/Ⅱ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel T-Cell bispecific (TCB), MBS303, administered by intravenous (IV) infusion in participants with relapsed or refractory B-cell NHL. This entry-to-human study consists of 2 parts: a dose escalation part (Phase I) and an expansion part (Phase Ⅱ)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able and willing to provide written informed consent and to comply with the studyprotocol.

  2. Adult patients, ≥18 years of age;

  3. CD20+ B-cell Non-Hodgkin Lymphoma who have relapsed after or failed to respond to atleast one prior treatment regimen with an anti-CD20 monoclonal antibody and for whomthere 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 nodallesion, defined as >1.5 cm in its longest dimension, or at least onebi-dimensionally measureable extranodal lesion, defined as >1.0 cm in its longestdimension

  7. Adequate hematologic, hepatic, and renal function.

Exclusion

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, tumorembolization, 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 toundergo 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 touse two reliable forms of contraception simultaneously or to practice completeabstinence from heterosexual contact during the following time periods related tothis study: 1) while participating in the study; 2) for at least 12 months afterdiscontinuation of all study treatments.

Study Design

Total Participants: 132
Treatment Group(s): 1
Primary Treatment: MBS303
Phase: 1/2
Study Start date:
June 28, 2023
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Beijing Cancer Hospital

    Beijing,
    China

    Active - Recruiting

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