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

NCT05267054 | Completed Phase 1 Results DMC

• 2 other identifiers: AdvanTIG-101CTR20220360
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 19

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)

Conditions

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

Keywords

Lymphoma; Tumor; Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug(s), whether considered related to study drug(s) or not. An SAE is any untoward medical occurrence that, at any dose: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Was a congenital anomaly/birth defect * Was considered a significant medical AE by the investigator based on medical judgement (eg, may jeopardize the patient or may require medical/surgical intervention to prevent one of the outcomes listed above).

  From first dose of study drug up to 30 days after last dose, maximum time on treatment was 98 weeks.

• 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%

  21 days

Secondary Outcomes (8)

• Overall Response Rate (ORR)

  From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

• Complete Response Rate (CRR)

  From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

• Duration of Response (DOR)

  Up to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

• Time to Response (TTR)

  From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

• Progression-free Survival (PFS)

  From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

Study Arms (2)

Ociperlimab + Tislelizumab

EXPERIMENTAL

Participants received ociperlimab 900 mg and tislelizumab 200 mg every three weeks (Q3W) by intravenous injection (IV) until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.

Drug: Ociperlimab; Drug: Tislelizumab

Ociperlimab + Rituximab

EXPERIMENTAL

Participants received ociperlimab 900 mg and rituximab 375 mg/m² Q3W by intravenous injection until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.

Drug: Ociperlimab; Drug: Rituximab

Interventions

Ociperlimab DRUG

administered intravenously

Also known as: BGB-A1217

Ociperlimab + Rituximab; Ociperlimab + Tislelizumab

Tislelizumab DRUG

Administered intravenously once every 3 weeks

Also known as: BGB-A317, Tevimbra

Ociperlimab + Tislelizumab

Rituximab DRUG

Administered intravenously once every 3 weeks

Ociperlimab + Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BeiGene: lead

Study Sites (19)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, 510080, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, 330006, China

Location

Jiangxi Province Cancer Hospital

Nanchang, Jiangxi, 330029, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, Sichuan, 610071, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma; Neoplasms

Interventions

tislelizumab; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

1 877-828-5568

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 4, 2022
• Study Start: April 25, 2022
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

CN (19)