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-T0920 in DLBCL and other aggressive B-Cell malignancies
NCT ID NCT07887646
First seen Oct 21, 2026 · Last updated Oct 21, 2026
Summary
The purpose of this study is to test the safety and tolerability of BG-T0920 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
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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-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: * 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 T-cell engager therapy (TCE) 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-T0920 or other monoclonal antibodies. * Unable to comply with the requirements of the protocol, unless the written approval of the medical monitor has been obtained before informed consent. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
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