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

Last updated: May 12, 2025
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphoma

Lymphoma, B-cell

Hematologic Cancer

Treatment

Oxaliplatin Injection

SHR-A1912 Injection

Gemcitabine Hydrochloride for Injection

Clinical Study ID

NCT06929624
SHR-A1912-301
  • Ages 18-80
  • All Genders

Study 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

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, hadgood compliance and were willing to cooperate with follow-up.

Exclusion

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 celltransplantation.

  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 firstdose.

Study Design

Total Participants: 280
Treatment Group(s): 4
Primary Treatment: Oxaliplatin Injection
Phase: 3
Study Start date:
April 24, 2025
Estimated Completion Date:
January 31, 2028

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

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