Clinical trial NCT05267054: Treatment of Relapsed or Refractory Diffuse Large B Cell Lymphoma With Ociperlimab (BGB A1217) in Combination With Tislelizumab (BGB A317) or Rituximab
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Relapsed Diffuse Large B-cell Lymphoma
Refractory Diffuse Large B-cell Lymphoma
Keywords: Lymphoma
Tumor
Large B-cell Lymphoma
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2022-03-04
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: Inclusion Criteria:

1. 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

1. Cohort 1: participants must have positive tumor PD L1 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:

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

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 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
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

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 2.5 years
measure: Recommended Phase 2 dose (RP2D) of ociperlimab when administered in combination with tislelizumab or rituximab
timeFrame: Up to 2.5 years
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 2.5 years
measure: Complete response rate (CRR)
timeFrame: Up to 2.5 years
measure: Duration of response (DOR)
timeFrame: Up to 2.5 years
measure: Time to response (TTR)
timeFrame: Up to 2.5 years
measure: Progression-free survival (PFS)
timeFrame: Up to 2.5 years
measure: Overall survival (OS)
timeFrame: Up to 2.5 years
measure: Serum concentration of ociperlimab in combination with tislelizumab or rituximab
timeFrame: Up to 2.5 years
measure: Host Immunogenicity: incidence of anti-drug antibodies (ADA) of ociperlimab (in combination with tislelizumab or rituximab)
timeFrame: Up to 2.5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Peoples Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University Branch Donghu
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Province Cancer Hospital
state: Jiangxi
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Affiliated Zhongshan Hospital of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: