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

Primary Purpose

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

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Ociperlimab
Tislelizumab
Rituximab
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed Diffuse Large B-cell Lymphoma focused on measuring Lymphoma, Tumor, Large B-cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Friendship Hospital, Capital Medical UniversityRecruiting
  • Beijing Cancer HospitalRecruiting
  • Beijing HospitalRecruiting
  • Zhujiang Hospital of Southern Medical UniversityRecruiting
  • Sun Yat Sen University Cancer CenterRecruiting
  • Guangdong Provincial Peoples HospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • Union Hospital of Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
  • Hunan Cancer HospitalRecruiting
  • The First Affiliated Hospital of Nanchang University Branch DonghuRecruiting
  • Jiangxi Province Cancer HospitalRecruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • Shandong Cancer HospitalRecruiting
  • Affiliated Zhongshan Hospital of Fudan UniversityRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples HospitalRecruiting
  • Tianjin Medical University Cancer Institute and HospitalRecruiting
  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1 (participants with PD-L1 positive on the surface of tumor cells)

Cohort 2 (participants with PD-L1 negative on the surface of tumor cells

Arm Description

participants will receive ociperlimab in combination with tislelizumab

participants will receive ociperlimab in combination with rituximab

Outcomes

Primary Outcome Measures

Number of participants with adverse events (AEs)
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
The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 33.3%

Secondary Outcome Measures

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)
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
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
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
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
Overall survival (OS)
OS is defined as the time from first study drug administration to the date of death due to any cause
Serum concentration of ociperlimab in combination with tislelizumab or rituximab
Host Immunogenicity: incidence of anti-drug antibodies (ADA) of ociperlimab (in combination with tislelizumab or rituximab)

Full Information

First Posted
February 10, 2022
Last Updated
August 29, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT05267054
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-cell Lymphoma
Keywords
Lymphoma, Tumor, Large B-cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 (participants with PD-L1 positive on the surface of tumor cells)
Arm Type
Experimental
Arm Description
participants will receive ociperlimab in combination with tislelizumab
Arm Title
Cohort 2 (participants with PD-L1 negative on the surface of tumor cells
Arm Type
Experimental
Arm Description
participants will receive ociperlimab in combination with rituximab
Intervention Type
Drug
Intervention Name(s)
Ociperlimab
Other Intervention Name(s)
BGB-A1217
Intervention Description
administered intravenously
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB A317
Intervention Description
administered intravenously
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
administered intravenously
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Description
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame
Up to 2.5 years
Title
Recommended Phase 2 dose (RP2D) of ociperlimab when administered in combination with tislelizumab or rituximab
Description
The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 33.3%
Time Frame
Up to 2.5 years
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Lugano Classification (2014)
Time Frame
Up to 2.5 years
Title
Complete response rate (CRR)
Description
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
Time Frame
Up to 2.5 years
Title
Duration of response (DOR)
Description
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
Time Frame
Up to 2.5 years
Title
Time to response (TTR)
Description
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
Time Frame
Up to 2.5 years
Title
Progression-free survival (PFS)
Description
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
Time Frame
Up to 2.5 years
Title
Overall survival (OS)
Description
OS is defined as the time from first study drug administration to the date of death due to any cause
Time Frame
Up to 2.5 years
Title
Serum concentration of ociperlimab in combination with tislelizumab or rituximab
Time Frame
Up to 2.5 years
Title
Host Immunogenicity: incidence of anti-drug antibodies (ADA) of ociperlimab (in combination with tislelizumab or rituximab)
Time Frame
Up to 2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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: 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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BeiGene
Phone
1.877.828.5568
Email
clinicaltrials@beigene.com
Facility Information:
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
Guangdong Provincial Peoples Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Nanchang University Branch Donghu
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangxi Province Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Zhongshan Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610071
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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