Treatment of Relapsed or Refractory Diffuse Large B Cell Lymphoma With Ociperlimab (BGB-A1217) in Combination With Tislelizumab (BGB-A317) or Rituximab
NCT ID: NCT05267054
Last Updated: 2025-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
53 participants
INTERVENTIONAL
2022-04-25
2024-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ociperlimab + Tislelizumab
Participants 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.
Ociperlimab
administered intravenously
Tislelizumab
Administered intravenously once every 3 weeks
Ociperlimab + Rituximab
Participants 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.
Ociperlimab
administered intravenously
Rituximab
Administered intravenously once every 3 weeks
Interventions
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Ociperlimab
administered intravenously
Tislelizumab
Administered intravenously once every 3 weeks
Rituximab
Administered intravenously once every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
Jiangxi Province Cancer Hospital
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CTR20220360
Identifier Type: OTHER
Identifier Source: secondary_id
AdvanTIG-101
Identifier Type: -
Identifier Source: org_study_id
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