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Relapsed Diffuse Large B-cell LymphomaPhase 1/2NCT05267054

Treatment of Relapsed or Refractory Diffuse Large B Cell Lymphoma With Ociperlimab (BGB-A1217) in Combination With Tislelizumab (BGB-A317) or Rituximab

A Phase 1/2 study testing Ociperlimab, Tislelizumab and Rituximab in people with Relapsed Diffuse Large B-cell Lymphoma and Refractory Diffuse Large B-cell Lymphoma, run by BeiGene at 19 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of this study is to assess the safety and tolerability of ociperlimab (BGB-A1217) in combination with tislelizumab (BGB-A317) or rituximab in participants with relapsed or refractory (R/R) diffuse large B cell lymphoma (DLBCL) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ociperlimab, Tislelizumab and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
19 sitesChina
Study dates
25 Apr 2022to 30 Aug 2024
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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
  • Cohort 1: participants must have positive tumor programmed cell death ligand-1 (PD-L1) immunohistochemistry (IHC) testing results as determined by local pathologist
  • 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.
  • 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.
  • Relapsed or refractory disease before study entry, defined as either:
  • Recurrent disease after having achieved disease remission (complete response or partial response) during or at the completion of the latest treatment regimen.
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  • Stable disease or progressive disease (PD) at the completion of the latest treatment regimen.
  • Ineligible for high dose therapy/hematopoietic stem cell transplantation
  • 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

Who cannot join

  • Current or history of central nervous system lymphoma
  • Histologically transformed lymphoma
  • Receipt of the following treatment:
  • 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
  • Recent treatment with another monoclonal antibody within 4 weeks before first dose of study drug
  • Investigational treatment within 4 weeks (or 5 half lives, whichever is shorter) before first dose of study drug
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  • Treatment with autologous stem cell transplantation within 6 months before first dose of study drug
  • Treatment with allogeneic hematopoietic stem cell transplantation or organ transplantation
  • 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.
  • Active autoimmune diseases or history of autoimmune diseases that may relapse, with the following exceptions:
  • Controlled Type 1 diabetes
  • Hypothyroidism (provided that it is managed with hormone replacement therapy only)
  • Controlled celiac disease
  • Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, or alopecia)
  • 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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan, 610071

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080

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

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

  • Jiangxi Province Cancer Hospital

    Nanchang, Jiangxi, 330029

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

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

    Wuhan, Hubei, 430022

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: A Phase 1b/2 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Ociperlimab (BGB-A1217) in Combination With Tislelizumab (BGB-A317) or Rituximab in Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma

The primary purpose of this study is to assess the safety and tolerability of ociperlimab (BGB-A1217) in combination with tislelizumab (BGB-A317) or rituximab in participants with relapsed or refractory (R/R) diffuse large B cell lymphoma (DLBCL)

Being tested
Ociperlimab, Tislelizumab, Rituximab
Keywords
Lymphoma, Tumor, Large B-cell Lymphoma
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OciperlimabDrug

    Also called BGB-A1217

    administered intravenously

  • TislelizumabDrug

    Also called BGB-A317, Tevimbra

    Administered intravenously once every 3 weeks

  • RituximabDrug

    Administered intravenously once every 3 weeks

Study groups in NCT05267054
Study groupRoleWhat they receive
Ociperlimab + TislelizumabExperimentalParticipants received ociperlimab 900 mg and tislelizumab 200 mg every three weeks (Q3W) by intravenous injection (IV) until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.
Receives: Drug: Ociperlimab; Drug: Tislelizumab
Ociperlimab + RituximabExperimentalParticipants received ociperlimab 900 mg and rituximab 375 mg/m² Q3W by intravenous injection until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.
Receives: Drug: Ociperlimab; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug(s), whether considered related to study drug(s) or not.

    An SAE is any untoward medical occurrence that, at any dose:

    • Resulted in death
    • Was life-threatening
    • Required hospitalization or prolongation of existing hospitalization
    • Resulted in disability/incapacity
    • Was a congenital anomaly/birth defect
    • Was considered a significant medical AE by the investigator based on medical judgement (eg, may jeopardize the patient or may require medical/surgical intervention to prevent one of the outcomes listed above).

    Measured: From first dose of study drug up to 30 days after last dose, maximum time on treatment was 98 weeks.

  2. Recommended Phase 2 Dose (RP2D) of Ociperlimab When Administered in Combination With Tislelizumab or Rituximab

    The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 33.3%

    Measured: 21 days

Secondary outcomes (8)

  1. Overall Response Rate (ORR)

    ORR is defined as the percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR) based on the Lugano classification as assessed by the investigator. Response was evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose-positron emission tomography (FDGPET).

    CR: complete metabolic (no/minimal FDG uptake and no evidence of FDG-avid disease in bone marrow) and radiologic response (target lesions regressed to ≤ 1.5 cm in longest diameter with no extra-lymphatic sites of disease, no organ enlargement and normal bone marrow morphology), no new lesions, and no bone marrow involvement confirmed by bone marrow biopsies (if bone marrow was involved at baseline).

    PR is partial metabolic (reduced FDG uptake from Baseline) and radiologic response (≥ 50% decrease in size of measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by > 50% in length beyond normal) and no new lesions.

    Measured: From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

  2. Complete Response Rate (CRR)

    CRR is defined as the percentage of participants who achieved a complete response per the Lugano Classification (2014) as assessed by the investigator.

    Measured: From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

  3. Duration of Response (DOR)

    DOR is defined as the time from the date that response criteria were first met to the date that progressive disease is objectively documented per Lugano Classification (2014), as assessed by the investigator, or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method.

    Measured: Up to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

  4. Time to Response (TTR)

    TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better) per Lugano Classification (2014) as assessed by the investigator

    Measured: From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

  5. Progression-free Survival (PFS)

    PFS is defined as the time from first dose until first documentation of progression per Lugano Classification (2014), as assessed by the investigator, or death, whichever comes first. Median PFS was estimated using the Kaplan-Meier method.

    Measured: From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

  6. Overall Survival (OS)

    OS is defined as the time from first study drug administration to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.

    Measured: From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

  7. Serum Concentration of Ociperlimab

    Measured: Predose and end of infusion (EOI) on Cycle 1 Day 1 (C1D1), Cycle 2 Day 1, Cycle 5 Day 1, Cycle 9 Day 1, and Cycle 17 Day 1

  8. Host Immunogenicity: Number of Participants With Anti-drug Antibodies (ADA) to Ociperlimab

    The number of participants with anti-drug antibodies to ociperlimab includes participants that were ADA-negative at Baseline and ADA-positive after drug administration during the treatment or follow-up observation period and participants who were positive at Baseline for ADA and with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period.

    Measured: From first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2022
  2. Study start25 Apr 2022
  3. Primary completion30 Aug 2024
  4. Study completion30 Aug 2024

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05267054
Sponsor's protocol ID
AdvanTIG-101
Other IDs
CTR20220360
Status last verified
Aug 2025
First submitted
10 Feb 2022
Last updated
15 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: BeiGene 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. BeiGene 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 BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ociperlimab, Tislelizumab and Rituximab in people with Relapsed Diffuse Large B-cell Lymphoma and Refractory Diffuse Large B-cell Lymphoma, run by BeiGene at 19 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From first dose of study drug up to 30 days after last dose, maximum time on treatment was 98 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05267054.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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