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New hope for tough lymphoma: drug cocktail shows promise

NCT ID NCT05267054

Disease control Sponsor: BeiGene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-phase trial tested a new drug called ociperlimab combined with either tislelizumab or rituximab in 53 people whose diffuse large B-cell lymphoma had returned or stopped responding to treatment. The main goal was to check safety and find the right dose. Researchers also looked at whether the tumors shrank. The study is complete, but results are not yet published.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ociperlimab, Tislelizumab, Rituximab
What this could lead to
If successful, this combination could offer a new treatment option for people with hard-to-treat diffuse large B-cell lymphoma.
What could go wrong
This is an early-phase trial with only 53 participants, so results may not apply broadly. Side effects from the drug combination could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

53 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically confirmed DLBCL NOS (Not Otherwise Specified), Epstein-Barr virus (EBV) + DLBCL NOS, or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma \[DHL/THL\]), based on the World Health Organization (WHO) 2016 classification of tumors of hematopoietic and lymphoid tissue 1. Cohort 1: participants must have positive tumor programmed cell death ligand-1 (PD-L1) immunohistochemistry (IHC) testing results as determined by local pathologist 2. Cohort 2: Participants must have negative tumor PD-L1 IHC results as determined by a local pathologist in the dose confirmation stage. The dose expansion stage can enroll participants regardless of PD-L1 expression. 2. Previously received ≥ 1 line of adequate systemic anti DLBCL therapy, defined as an anti CD20 antibody based chemoimmunotherapy for ≥ 2 consecutive cycles, unless participants had PD before Cycle 2. 3. Relapsed or refractory disease before study entry, defined as either: 1. Recurrent disease after having achieved disease remission (complete response or partial response) during or at the completion of the latest treatment regimen. 2. Stable disease or progressive disease (PD) at the completion of the latest treatment regimen. 4. Ineligible for high dose therapy/hematopoietic stem cell transplantation 5. Measurable disease as assessed by computed tomography (CT) or magnetic resonance imaging (MRI) and defined as at least 1 lymph node \> 1.5 cm in the longest diameter and/or at least 1 extranodal lesion \> 1.0 cm in the longest diameter, and measurable lesion (s) in 2 perpendicular diameters Exclusion Criteria: 1. Current or history of central nervous system lymphoma 2. Histologically transformed lymphoma 3. Receipt of the following treatment: 1. Systemic chemotherapy, targeted small molecule therapy or radiation therapy within 4 weeks (or 5 half lives, whichever is shorter) before first dose of study drug 2. Recent treatment with another monoclonal antibody within 4 weeks before first dose of study drug 3. Investigational treatment within 4 weeks (or 5 half lives, whichever is shorter) before first dose of study drug 4. Treatment with autologous stem cell transplantation within 6 months before first dose of study drug 5. Treatment with allogeneic hematopoietic stem cell transplantation or organ transplantation 6. Treatment with anti-programmed cell death protein-1 (PD-1), anti PD-L1, anti PD-L2, anti T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT), anti CTLA4 or other antibody or drug specifically targeting T cell costimulation or checkpoint pathways. 4. Active autoimmune diseases or history of autoimmune diseases that may relapse, with the following exceptions: 1. Controlled Type 1 diabetes 2. Hypothyroidism (provided that it is managed with hormone replacement therapy only) 3. Controlled celiac disease 4. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, or alopecia) 5. Any other disease that is not expected to recur in the absence of external triggering factors Note: Other protocol defined Inclusion/Exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma lymphoma neoplasm relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Refractory diffuse large B-cell lymphoma Relapsed diffuse large B cell lymphoma

Contacts and locations

Locations

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032, China

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050, China

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730, China

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Jiangxi Province Cancer Hospital

    Nanchang, Jiangxi, 330029, China

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004, China

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan, 610071, China

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016, China

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000, China

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