Status:
COMPLETED
Treatment of Relapsed or Refractory Diffuse Large B Cell Lymphoma With Ociperlimab (BGB-A1217) in Combination With Tislelizumab (BGB-A317) or Rituximab
Lead Sponsor:
BeiGene
Conditions:
Relapsed Diffuse Large B-cell Lymphoma
Refractory Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 refracto...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
April 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT05267054
Start Date
April 25 2022
End Date
August 30 2024
Last Update
September 15 2025
Active Locations (19)
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1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
3
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
4
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510000