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

November 14, 2025 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Principal Investigator:
          • Yuqin Song
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Principal Investigator:
          • Zhiming Li
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin
Drug: SHR-A1912 Injection
SHR-A1912 injection.
Drug: Rituximab Injection
Rituximab injection.
Drug: Gemcitabine Hydrochloride for Injection
Gemcitabine hydrochloride for injection.
Drug: Oxaliplatin Injection
Oxaliplatin injection.
Active Comparator: Rituximab + Gemcitabine + Oxaliplatin
Drug: Rituximab Injection
Rituximab injection.
Drug: Gemcitabine Hydrochloride for Injection
Gemcitabine hydrochloride for injection.
Drug: Oxaliplatin Injection
Oxaliplatin injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete response rate (CRR)
Time Frame: Up to 1 years following the first dose of the last enrolled patient.
Up to 1 years following the first dose of the last enrolled patient.
Overall survival (OS)
Time Frame: Up to 5 years following the first dose of the last enrolled patient.
Up to 5 years following the first dose of the last enrolled patient.

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events (AEs)
Time Frame: Up to 5 years following the first dose of the last enrolled patient.
Up to 5 years following the first dose of the last enrolled patient.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-A1912-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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