Diffuse Large B-Cell LymphomaPhase 1NCT07881211
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
A Phase 1 study testing BG-T0050 in people with Diffuse Large B-Cell Lymphoma and B-Cell Malignancies, run by BeOne Medicines.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma, B-Cell Malignancies
- What is being tested?
- BG-T0050
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 31 Oct 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A First-in-Human, Phase 1, Open-Label, Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-T0050 in DLBCL and Other Aggressive B-Cell Malignancies
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
Read the detailed description
Diffuse large B-cell lymphoma (DLBCL) is a fast-growing blood cancer that affects a type of white blood cell called B-cell lymphocytes. The cancer cells most commonly develop in the lymph nodes but may also spread to tissues and organs outside the lymph nodes.
BG-T0050 is an antibody-based immunotherapy drug that is designed to attach to both cancer cells and healthy immune cells (called T-cells). This brings the T-cells into close contact with the cancer cells, helping the T-cells find and destroy the cancer cells.
The purpose of this study is to test whether BG-T0050 is safe and if it can help treat adults with diffuse large B-cell lymphoma or other aggressive B-cell malignancies. The main goal of the study is to test the safety and tolerability of BG-T0050 and to identify the recommended dose and dosing schedule in participants with DLBCL and other aggressive B-cell malignancies.
This study consists of 2 parts, one called dose escalation and one called dose expansion. During the dose escalation part, the study doctors will test different doses of the study drug to find the recommended dose that people can take without having serious side effects. During the dose expansion part, the study doctors will test the study drug in a larger number of people using the dose[s] identified from dose escalation.
The study will enroll approximately 70 adult participants at multiple centers worldwide with DLBCL and other aggressive B-cell malignancies.
The overall time to participate in this study is 24 months. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.
- Conditions
- Diffuse Large B-Cell Lymphoma, B-Cell Malignancies
- Being tested
- BG-T0050
- Keywords
- Diffuse large B-cell lymphoma, DLBCL, B-Cell Malignancies, Cluster of differentiation (CD) 20, Cluster of differentiation (CD) 19
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG-T0050Drug
Administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Part 1a Dose Escalation of BG-T0050 | Experimental | Sequential cohorts of increasing dose levels of BG-T0050 will be evaluated as monotherapy. Receives: 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. Receives: Drug: BG-T0050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1a Dose Escalation: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Measured: 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)
Measured: From first dose until 30 days after the last dose; approximately 13 months
Secondary outcomes (9)
Overall Response Rate (ORR) Assessed by the Investigator
ORR is defined as the percentage of participants with a best overall response of partial response or better per the Lugano Classification for non-Hodgkin lymphoma
Measured: Approximately 24 months
Complete Response Rate (CRR)
CRR is defined as the percentage of patients with best overall response of complete response per the Lugano Classification
Measured: Approximately 24 months
Duration of Response (DOR)
DOR is defined as the time from the first response to documented disease progression or death due to any cause, whichever occurs first
Measured: Approximately 24 months
Time to Response (TTR)
TRR is defined as the time from first dose to the first response
Measured: Approximately 24 months
Maximum Observed Plasma Concentration (Cmax) of BG-T0050
Measured: Up to 1 month
Trough Concentration (Ctrough) of BG-T0050
Measured: Up to 13 months
Area Under the Plasma Concentration-time Curve (AUC) of BG-T0050
Measured: Up to 13 months
Serum Concentration of BG-T0050
Measured: Up to 13 months
Percentage of Patients Developing Antidrug Antibodies Against BG-T0050
Measured: Up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881211
- Sponsor's protocol ID
- BG-T0050-101
- Other IDs
- 2026-527814-21-00
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.