RecruitingPhase 3NCT06929624

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

A Phase 3, Open-label, Randomized Study of SHR-A1912 Combined With Rituximab + Gemcitabine + Oxaliplatin (R-GEMOX) Versus R-GEMOX in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

280 participants

Start Date

Apr 24, 2025

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

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 Criteria6

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.