Diffuse Large B-cell LymphomaPhase 3NCT06929624
A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma
A Phase 3 study testing SHR-A1912 Injection, Rituximab Injection and Gemcitabine Hydrochloride for Injection in people with Diffuse Large B-cell Lymphoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- SHR-A1912 Injection, Rituximab Injection and Gemcitabine Hydrochloride for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 2 sitesChina
- Study dates
- 24 Apr 2025to Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
About this study
Official 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
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.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- SHR-A1912 Injection, Rituximab Injection, Gemcitabine Hydrochloride for Injection, Oxaliplatin Injection
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1912 InjectionDrug
SHR-A1912 injection.
Rituximab InjectionDrug
Rituximab injection.
Gemcitabine Hydrochloride for InjectionDrug
Gemcitabine hydrochloride for injection.
Oxaliplatin InjectionDrug
Oxaliplatin injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin | Experimental | Not described Receives: Drug: SHR-A1912 Injection; Drug: Rituximab Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Oxaliplatin Injection |
| Rituximab + Gemcitabine + Oxaliplatin | Active comparator | Not described Receives: Drug: Rituximab Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Oxaliplatin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate (CRR)
Measured: Up to 1 years following the first dose of the last enrolled patient.
Overall survival (OS)
Measured: Up to 5 years following the first dose of the last enrolled patient.
Secondary outcomes (1)
Adverse events (AEs)
Measured: Up to 5 years following the first dose of the last enrolled patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start24 Apr 2025
- Primary completionMar 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929624
- Sponsor's protocol ID
- SHR-A1912-301
- Status last verified
- Sep 2026
- First submitted
- 8 Apr 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06929624
- Acronym / sponsor ID
- SHR-A1912-301
- Conditions
- Diffuse Large B-cell Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin | Experimental | Drug: SHR-A1912 Injection, Drug: Rituximab Injection, Drug: Gemcitabine Hydrochloride for Injection, Drug: Oxaliplatin Injection |
| Rituximab + Gemcitabine + Oxaliplatin | Active comparator | Drug: Rituximab Injection, Drug: Gemcitabine Hydrochloride for Injection, Drug: Oxaliplatin Injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-A1912 InjectionSHR-A1912 injection. | Drug | SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin |
| Rituximab InjectionRituximab injection. | Drug | Rituximab + Gemcitabine + Oxaliplatin, SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin |
| Gemcitabine Hydrochloride for InjectionGemcitabine hydrochloride for injection. | Drug | Rituximab + Gemcitabine + Oxaliplatin, SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin |
| Oxaliplatin InjectionOxaliplatin injection. | Drug | Rituximab + Gemcitabine + Oxaliplatin, SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin |
Primary outcome
Complete response rate (CRR)
Time frame: 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.
1 secondary outcome
Adverse events (AEs)
Time frame: Up to 5 years following the first dose of the last enrolled patient.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-A1912 Injection, Rituximab Injection and Gemcitabine Hydrochloride for Injection in people with Diffuse Large B-cell Lymphoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (CRR) (time frame: Up to 1 years following the first dose of the last enrolled patient.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.