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

Sponsor
BeiGene
Study ID
NCT05267054
Phase
PHASE1/PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ociperlimab — DRUG
    administered intravenously
  • Tislelizumab — DRUG
    Administered intravenously once every 3 weeks
  • Rituximab — DRUG
    Administered intravenously once every 3 weeks

Study Details

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)

Key Dates

Start date
Apr 25, 2022
Status verified
Aug 2025
Primary completion
Aug 30, 2024
Completion
Aug 30, 2024

Study Design

Enrollment
53 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ociperlimab + Tislelizumab
    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.
  • Experimental: Ociperlimab + Rituximab
    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.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose of study drug up to 30 days after last dose, maximum time on treatment was 98 weeks. ]

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