A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma

Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study ID
NCT06929624
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-A1912 Injection — DRUG
    SHR-A1912 injection.
  • Rituximab Injection — DRUG
    Rituximab injection.
  • Gemcitabine Hydrochloride for Injection — DRUG
    Gemcitabine hydrochloride for injection.
  • Oxaliplatin Injection — DRUG
    Oxaliplatin injection.

Study Details

This is a multicenter, randomized, open-label, phase 3 clinical study to evaluate the efficacy of SHR-A1912 combined with R-GemOx in relapsed refractory diffuse large B-cell lymphoma.

Key Dates

Start date
Apr 24, 2025
Status verified
Nov 2025
Primary completion
Mar 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin
  • Active Comparator: Rituximab + Gemcitabine + Oxaliplatin

Primary Outcome Measure

Complete response rate (CRR) [ Time Frame: Up to 1 years following the first dose of the last enrolled patient. ]

Central Contacts

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