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

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

Recruiting
18-80 years
All
Phase 3

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Overview

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

Inclusion Criteria:

  1. Histologically confirmed diffuse large B-cell lymphoma (DLBCL).
  2. Have received ≥1 line of systemic antitumor therapy.
  3. At least one bi-dimensionally measurable lesion.
  4. Expected survival of at least 3 months.
  5. Age ≥18 years old and under 80 years old.
  6. The patients voluntarily participated in the study, signed informed consent, had good compliance and were willing to cooperate with follow-up.

Exclusion Criteria:

  1. Central nervous system lymphoma involvement.
  2. Primary mediastinal (thymus) large B-cell lymphoma.
  3. Patients who have only one prior line therapy and are candidates for stem cell transplantation.
  4. A history of immunodeficiency.
  5. A history of severe cardiovascular disease.
  6. A history of other malignancies within 5 years prior to administration of the first dose.

Study details
    Diffuse Large B-cell Lymphoma

NCT06929624

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

15 October 2025

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