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

Refractory Diffuse Large B-cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05267054
• Other study ID #: AdvanTIG-101
• Secondary ID: CTR20220360
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 25, 2022
• Est. completion date: February 2025

Study information

• Verified date: August 2023
• Source: BeiGene
• Contact: BeiGene
• Phone: 1.877.828.5568
• Email: clinicaltrials[@]beigene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

a. Cohort 1: participants must have positive tumor PD L1 IHC testing results as determined by local pathologist b. Cohort 2: participants must have negative tumor PD L1 IHC testing results as determined by local pathologist

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Refractory Diffuse Large B-cell Lymphoma
• Relapsed Diffuse Large B-cell Lymphoma

Intervention

Drug:
• Ociperlimab
administered intravenously
• Tislelizumab
administered intravenously
• Rituximab
administered intravenously

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital	Chengdu	Sichuan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Guangdong Provincial Peoples Hospital	Guangzhou	Guangdong
China	Sun Yat Sen University Cancer Center	Guangzhou	Guangdong
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Shandong Cancer Hospital	Jinan	Shandong
China	Jiangxi Province Cancer Hospital	Nanchang	Jiangxi
China	The First Affiliated Hospital of Nanchang University Branch Donghu	Nanchang	Jiangxi
China	Affiliated Zhongshan Hospital of Fudan University	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Union Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)	Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	Up to 2.5 years
Primary	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%	Up to 2.5 years
Secondary	Overall Response Rate (ORR)	ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Lugano Classification (2014)	Up to 2.5 years
Secondary	Complete response rate (CRR)	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	Up to 2.5 years
Secondary	Duration of response (DOR)	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	Up to 2.5 years
Secondary	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	Up to 2.5 years
Secondary	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	Up to 2.5 years
Secondary	Overall survival (OS)	OS is defined as the time from first study drug administration to the date of death due to any cause	Up to 2.5 years
Secondary	Serum concentration of ociperlimab in combination with tislelizumab or rituximab		Up to 2.5 years
Secondary	Host Immunogenicity: incidence of anti-drug antibodies (ADA) of ociperlimab (in combination with tislelizumab or rituximab)		Up to 2.5 years