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Not yet recruitingNCT07881211Updated Oct 19, 2026

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 interventional study of BG-T0050 in Diffuse Large B-Cell Lymphoma and B-Cell Malignancies, sponsored by BeOne Medicines. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by BeOne Medicines · Phase 1, Interventional, and Treatment

Updated Oct 19, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Diffuse Large B-Cell Lymphoma
  • B-Cell Malignancies

Keywords

  • Diffuse large B-cell lymphoma
  • DLBCL
  • B-Cell Malignancies
  • Cluster of differentiation (CD) 20
  • Cluster of differentiation (CD) 19
03

In context

Lymphoma, Large B-Cell, Diffuse

1,432 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 359 are open to participants now.

This study's planned enrollment of 70 is above the median of 47 across 1,214 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.

Browse Lymphoma, Large B-Cell, Diffuse studies →

Lead sponsor

BeOne Medicines is the lead sponsor of 64 studies on the registry; 44 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse BeOne Medicines studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Confirmed diagnosis of any of the below according to World Health Organization (WHO) classification

    1. Diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS)
    2. Diffuse large B-cell lymphoma / high-grade B-cell lymphoma (DLBCL/HG-BCL) with MYC and BCL2 rearrangements
    3. High-grade B-cell lymphoma, not otherwise specified (HG-BCL, NOS)
    4. 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.

Exclusion criteria

Exclusion Criteria:

  • 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:

    1. Biologic-based anti-lymphoma therapy (eg, monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugate, or TCE therapy) within 28 days
    2. CAR-T therapy within 90 days
    3. Systemic chemotherapy or small-molecule targeted therapy (investigational or otherwise) within 28 days or 5 half-lives (whichever is shorter)
    4. 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.
    5. 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
    6. 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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Part 1a Dose Escalation of BG-T0050

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

    Drug: BG-T0050

  • Experimental
    Part 1b Dose Expansion of BG-T0050

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

    Drug: BG-T0050

Interventions

  • DrugBG-T0050

    Administered subcutaneously

06

What researchers measure

Primary outcomes

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

    Time frame: Approximately 1 Month

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

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

Secondary outcomes

  1. 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

    Time frame: Approximately 24 months

  2. Complete Response Rate (CRR)

    CRR is defined as the percentage of patients with best overall response of complete response per the Lugano Classification

    Time frame: Approximately 24 months

  3. 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

    Time frame: Approximately 24 months

  4. Time to Response (TTR)

    TRR is defined as the time from first dose to the first response

    Time frame: Approximately 24 months

  5. Maximum Observed Plasma Concentration (Cmax) of BG-T0050

    Time frame: Up to 1 month

  6. Trough Concentration (Ctrough) of BG-T0050

    Time frame: Up to 13 months

  7. Area Under the Plasma Concentration-time Curve (AUC) of BG-T0050

    Time frame: Up to 13 months

  8. Serum Concentration of BG-T0050

    Time frame: Up to 13 months

  9. Percentage of Patients Developing Antidrug Antibodies Against BG-T0050

    Time frame: Up to 13 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: See plan description

Access criteria: See plan description

Data sharing details ↗ · beonemedicines.com

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Oct 2029, 35 months later.

Of 84 industry-sponsored phase 1 interventional studies under Lymphoma, Large B-Cell, Diffuse, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 64. This study's planned 35 months is below that.

Counting every sponsor, half of 182 studies reached it within 52 months; a quarter within 36 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2026
First posted
Oct 19, 2026
StartEst.
Nov 30, 2026
Primary completionEst.
Oct 31, 2029
CompletionEst.
Oct 31, 2029
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07881211
Lead sponsor
BeOne Medicines
Responsible party
Sponsor
First posted
Oct 19, 2026
Start date
Nov 30, 2026 (estimated)
Primary completion
Oct 31, 2029 (estimated)
Completion
Oct 31, 2029 (estimated)
Last update
Oct 19, 2026

Study contacts

Study Director
Contact
clinicaltrials@beonemed.com
1.877.828.5568
Study Director
study director · BeOne Medicines

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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