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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT06929624•Suzhou Suncadia Biopharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

April 24, 2025

Primary Completion Date

March 1, 2027

Completion Date

January 1, 2028

Last Updated

November 18, 2025

Enrollment

280

ESTIMATED participants

Conditions

Diffuse Large B-cell Lymphoma

Interventions

SHR-A1912 Injection

DRUG

Rituximab Injection

DRUG

Gemcitabine Hydrochloride for Injection

DRUG

Oxaliplatin Injection

DRUG

Contacts

Mengbo Zhao

CONTACT

+86-0518-82342973 mengbo.zhao@hengrui.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

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