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NCT Number: NCT06929624

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

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.

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Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Complete response rate (CRR)

    Time frame: Up to 1 years following the first dose of the last enrolled patient.

  2. Overall survival (OS)

    Time frame: Up to 5 years following the first dose of the last enrolled patient.

Secondary outcomes

  1. Adverse events (AEs)

    Time frame: Up to 5 years following the first dose of the last enrolled patient.

Study contacts

Contact information is provided by the study sponsor or research team.

Mengbo Zhao

CONTACT

[email protected]

+86-0518-82342973

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 16, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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