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

NCT ID: NCT06929624

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-24

Study Completion Date

2028-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diffuse Large B-cell Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin

Group Type EXPERIMENTAL

SHR-A1912 Injection

Intervention Type DRUG

SHR-A1912 injection.

Rituximab Injection

Intervention Type DRUG

Rituximab injection.

Gemcitabine Hydrochloride for Injection

Intervention Type DRUG

Gemcitabine hydrochloride for injection.

Oxaliplatin Injection

Intervention Type DRUG

Oxaliplatin injection.

Rituximab + Gemcitabine + Oxaliplatin

Group Type ACTIVE_COMPARATOR

Rituximab Injection

Intervention Type DRUG

Rituximab injection.

Gemcitabine Hydrochloride for Injection

Intervention Type DRUG

Gemcitabine hydrochloride for injection.

Oxaliplatin Injection

Intervention Type DRUG

Oxaliplatin injection.

Interventions

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SHR-A1912 Injection

SHR-A1912 injection.

Intervention Type DRUG

Rituximab Injection

Rituximab injection.

Intervention Type DRUG

Gemcitabine Hydrochloride for Injection

Gemcitabine hydrochloride for injection.

Intervention Type DRUG

Oxaliplatin Injection

Oxaliplatin injection.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mengbo Zhao

Role: CONTACT

+86-0518-82342973

Facility Contacts

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Yuqin Song

Role: primary

+86-010-88140650

Zhiming Li

Role: primary

+86-020-87343392

Other Identifiers

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SHR-A1912-301

Identifier Type: -

Identifier Source: org_study_id

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