Treatment of Relapsed or Refractory Diffuse Large B Cell Lymphoma With Ociperlimab (BGB A1217) in Combination With Tislelizumab (BGB A317) or Rituximab
- Conditions
- Relapsed Diffuse Large B-cell LymphomaRefractory Diffuse Large B-cell Lymphoma
- Interventions
- Registration Number
- NCT05267054
- Lead Sponsor
- BeiGene
- Brief 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
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Histologically confirmed DLBCL NOS (Not Otherwise Specified), 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
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Cohort 1: participants must have positive tumor PD L1 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 3.
Relapsed or refractory disease before study entry, defined as either:
a. Recurrent disease after having achieved disease remission (CR or PR) during or at the completion of the latest treatment regimen b. Stable disease or PD at the completion of the latest treatment regimen
- 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
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Current or history of central nervous system lymphoma
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Histologically transformed lymphoma
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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
- 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 PD-1, anti PD-L1, anti PD-L2, anti TIGIT, anti CTLA4 or other antibody or drug specifically targeting T cell costimulation or checkpoint pathways
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 Tislelizumab Participants with PD-L1 positive tumor cells will receive ociperlimab combined with tislelizumab Cohort 2 Ociperlimab Participants in the dose confirmation stage with PD-L1 negative tumor cells, and those in the dose expansion stage regardless of PD-L1 expression, will receive ociperlimab combined with rituximab Cohort 1 Ociperlimab Participants with PD-L1 positive tumor cells will receive ociperlimab combined with tislelizumab Cohort 2 Rituximab Participants in the dose confirmation stage with PD-L1 negative tumor cells, and those in the dose expansion stage regardless of PD-L1 expression, will receive ociperlimab combined with rituximab
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Up to 2.5 years Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Recommended Phase 2 dose (RP2D) of ociperlimab when administered in combination with tislelizumab or rituximab Up to 2.5 years The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 33.3%
- Secondary Outcome Measures
Name Time Method Complete response rate (CRR) Up to 2.5 years CRR is defined as the percentage of participants who achieve a complete response per RECIST v1.1 Lugano Classification (2014) as assessed by the investigator
Duration of response (DOR) Up to 2.5 years DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented per Lugano Classification (2014), as assessed by the investigator, or death, whichever comes first
Overall survival (OS) Up to 2.5 years OS is defined as the time from first study drug administration to the date of death due to any cause
Host Immunogenicity: incidence of anti-drug antibodies (ADA) of ociperlimab (in combination with tislelizumab or rituximab) Up to 2.5 years Overall Response Rate (ORR) Up to 2.5 years ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Lugano Classification (2014)
Time to response (TTR) Up to 2.5 years 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
Progression-free survival (PFS) Up to 2.5 years 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
Serum concentration of ociperlimab in combination with tislelizumab or rituximab Up to 2.5 years
Trial Locations
- Locations (19)
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, 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
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, 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, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China