Status:
RECRUITING
A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL).
- Have received ≥1 line of systemic antitumor therapy.
- At least one bi-dimensionally measurable lesion.
- Expected survival of at least 3 months.
- Age ≥18 years old and under 80 years old.
- The patients voluntarily participated in the study, signed informed consent, had good compliance and were willing to cooperate with follow-up.
Exclusion
- Central nervous system lymphoma involvement.
- Primary mediastinal (thymus) large B-cell lymphoma.
- Patients who have only one prior line therapy and are candidates for stem cell transplantation.
- A history of immunodeficiency.
- A history of severe cardiovascular disease.
- A history of other malignancies within 5 years prior to administration of the first dose.
Key Trial Info
Start Date :
April 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT06929624
Start Date
April 24 2025
End Date
January 1 2028
Last Update
November 18 2025
Active Locations (2)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060