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

NCT05806099 | Recruiting Phase 1 DMC

• 1 other identifier: MBS303-CT101
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (5)

• Phase I：Percentage of Participants with Adverse Events (AEs)

  Percentage of Participants with AEs and SAEs Assessed by NCI CTCAE v5.0

  From Baseline up to approximately 13 months

• Phase I：Incidence of Dose Limiting Toxicities (DLTs)

  From Baseline up to 3 weeks

• Phase I：Maximum Tolerated Dose (MTD) of MBS303

  From Baseline up to 3 weeks

• Phase I：Recommended Phase Ⅱ Dose (RP2D) of MBS303

  From Baseline up to 4 years

• Phase Ⅱ ：Antitumor activity as measured by the objective response rate (ORR)

  Up to approximately 2 years

Secondary Outcomes (10)

• Phase I and Ⅱ ：Pharmacokinetics: AUC

  up to approximately 1 year

• Phase I and Ⅱ ：Pharmacokinetics: t1/2

  up to approximately 1 year

• Phase I and Ⅱ ：Pharmacokinetics: CL

  up to approximately 1 year

• Phase I and Ⅱ ：Pharmacokinetics: Vd

  up to approximately 1 year

• Phase I and Ⅱ ：Efficacy: Complete Response Rate (CRR) of MBS303 as Assessed Using Standard Criteria for NHL

  Up to approximately 2 years

Study Arms (1)

MBS303

EXPERIMENTAL

Drug: MBS303

Interventions

MBS303 DRUG

Phase I: The patients confirming to the eligibility criteria will be assigned to one of the 7 dose groups (0.05/0.15/0.45 mg \~ 1.5/6/60 mg, respectively) based on the sequence of inclusion. Each patient will receive MBS303 as per the schedule specified in the respective arms. Based on the safety data of the previous dose groups, if pretreatment with MIL62 is required after disussion by the sponsor and the investigators, the subject should be given an IV infusion of MIL62 1000 mg single dose on the D-7. Phase Ⅱ: One or two recommended doses will be selected based on the results of Phase I. Each patient will receive one of the two recommended doses MBS303 as step-up doses on D1 (low dose) and D8 (intermediate dose) of C1 and at the target dose on D1 of C2-17 (21-day cycles). Based on the previous safety data, if pretreatment with MIL62 is required after disussion by the sponsor and the investigators, the subjects should be given an IV infusion of MIL62 1000 mg single dose on the D-7

MBS303

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent and to comply with the study protocol.
• Adult patients, ≥18 years of age;
• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Life expectancy ≥3 months;
• 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
• Adequate hematologic, hepatic, and renal function.

You may not qualify if:

• Chronic lymphoblastic leukemia, Burkitt lymphoma or lymphoplasmacytic lymphom;
• History of central nervous system (CNS) lymphoma or other CNS disease;
• Participants with known active infection, including bacterial, viral, parasite, mycobacterial, or other infections (excluding nail bed fungal infections);
• Surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, tumor embolization, or other antitumor therapy within 28 days prior to the first MBS303;
• Active or suspected autoimmune diseases;
• Known severe allergic reaction or/and infusion reaction to monoclonal antibody;
• Evidence of significant, uncontrolled concomitant disease;
• Major surgery within 28 days prior to the first MBS303 administration or expected to undergo major surgery during the study treatment;
• History of another invasive malignant tumors in past 3 years;
• Participant with history of confirmed progressive multifocal leukoencephalopathy (PML);
• Severe hemorrhagic diseases such as hemophilia A, hemophilia B, vascular hemophilia, or spontaneous bleeding requiring blood transfusion or other medical intervention;
• Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal HBV DNA or HCV RNA);
• 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.

Sponsors & Collaborators

• Beijing Mabworks Biotech Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Yuqin Song, Doctor

CONTACT

8610-88196118; SongYQ_VIP@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 10, 2023
• Study Start: June 28, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-07

Locations

CN (1)