A Study Investigating the Safety and How the Trispecific T-Cell Engaging Antibody BG-T0050 Works in Adults With Diffuse Large B-cell Lymphoma (DLBCL) and Other Aggressive B-Cell Malignancies

NCT07881211 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: BG-T0050-1012026-527814-21-00
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to test the safety and tolerability of BG-T0050 and to identify the recommended dose and dosing schedule (including dose levels and timing) that can be taken without having serious side effects in adults with DLBCL and other aggressive B-cell malignancies

Conditions

B-Cell Malignancies; Diffuse Large B-Cell Lymphoma

Keywords

Diffuse large B-cell lymphoma; DLBCL; B-Cell Malignancies; Cluster of differentiation (CD) 20; Cluster of differentiation (CD) 19

Outcome Measures

Primary Outcomes (2)

• Part 1a Dose Escalation: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

  Approximately 1 Month

• Part 1a and Part 1b: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Treatment-related Adverse Events (TRAEs), and Serious Adverse Events (SAEs)

  From first dose until 30 days after the last dose; approximately 13 months

Secondary Outcomes (9)

• Overall Response Rate (ORR) Assessed by the Investigator

  Approximately 24 months

• Complete Response Rate (CRR)

  Approximately 24 months

• Duration of Response (DOR)

  Approximately 24 months

• Time to Response (TTR)

  Approximately 24 months

• Maximum Observed Plasma Concentration (Cmax) of BG-T0050

  Up to 1 month

Study Arms (2)

Part 1a Dose Escalation of BG-T0050

EXPERIMENTAL

Sequential cohorts of increasing dose levels of BG-T0050 will be evaluated as monotherapy.

Drug: BG-T0050

Part 1b Dose Expansion of BG-T0050

EXPERIMENTAL

The recommended dose(s) for expansion (RDFE) for BG-T0050 from Part 1a will be evaluated.

Drug: BG-T0050

Interventions

BG-T0050 DRUG

Administered subcutaneously

Part 1a Dose Escalation of BG-T0050; Part 1b Dose Expansion of BG-T0050

Eligibility Criteria

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

You may qualify if:

• Confirmed diagnosis of any of the below according to World Health Organization (WHO) classification
• Diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS)
• Diffuse large B-cell lymphoma / high-grade B-cell lymphoma (DLBCL/HG-BCL) with MYC and BCL2 rearrangements
• High-grade B-cell lymphoma, not otherwise specified (HG-BCL, NOS)
• Large B-cell lymphoma (LBCL) transformed from an antecedent indolent B-cell lymphoma (BCL), including Follicular lymphoma (FL) and marginal zone lymphoma (MZL)
• Must have relapsed or refractory disease with no other available therapies with established clinical benefit including anti-cluster of differentiation 20 (CD20)-based immunochemotherapy, autologous stem cell transplant \[if eligible\], chimeric antigen receptor T-cell therapy (CAR-T) \[if eligible\], or T-cell engager (TCE) therapy) that would be more appropriate in the investigator's judgment.
• Must have measurable disease by computed tomography (CT)/ magnetic resonance imaging (MRI), defined as at least 1 lymph node \> 1.5 cm in the longest diameter or 1 extranodal lesion \> 1.0 cm in the longest diameter, measurable in 2 perpendicular dimensions.
• Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.

You may not qualify if:

• Prior autologous stem cell transplant \< 100 days before first dose of the study drug.
• Prior allogenic transplant or solid organ transplant at any time in the past.
• Known or suspected progressive multifocal leukoencephalopathy.
• Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
• Recent prior therapies, prior to the first dose of study drug:
• Biologic-based anti-lymphoma therapy (eg, monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugate, or TCE therapy) within 28 days
• CAR-T therapy within 90 days
• Systemic chemotherapy or small-molecule targeted therapy (investigational or otherwise) within 28 days or 5 half-lives (whichever is shorter)
• Systemic corticosteroids in excess of 25 mg/day prednisone (or equivalent) within 14 days. Inhaled, topical, or systemic corticosteroids at doses of ≤ 25 mg/day prednisone (or equivalent) are permitted.
• Radiation therapy within 14 days. If a patient has undergone radiation therapy since last progression, at least one measurable lesion must be outside the radiation field
• T-cell suppressive therapy (eg, alemtuzumab, fludarabine) within 6 months, unless discussed with the medical monitor.
• History of severe allergic reactions or hypersensitivity to the active ingredient or excipients of BG-T0050 or other monoclonal antibodies.
• Active significant infection (bacterial, viral, fungal, parasitic) at study enrollment, or any Grade 3 or 4 infection requiring treatment with Intravenous (IV) systemic therapy or hospitalization within 4 weeks prior to the first dose of the study drug. Note: Oral antimicrobial therapy used for minor or controlled infections or for prophylactic purposes is allowed.

Sponsors & Collaborators

• BeOne Medicines: lead

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1.877.828.5568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2026
• First Posted: October 19, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: October 19, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description