Systemic Lupus ErthematosusPhase 1/2NCT07348055
A Study of GR1803 in Systemic Lupus Erythematosus
A Phase 1/2 study testing GR1803 injection in people with Systemic Lupus Erthematosus and Auto Immune Disease, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
to evaluate the safety and efficacy of GR1803 in the treatment of patients with systemic lupus erythematosus Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Systemic Lupus Erthematosus, Auto Immune Disease
- What is being tested?
- GR1803 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2026to 1 Dec 2027
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- comfirmed diagnosis of systemic lupus erythematosus
- SLEDAI-2K≥6分
- written informed consent and ability to comply with protocol requirements
- have received adequate dose of glucocorticoids, antimalarials, immunosuppressants for 3 months
Who cannot join
- with unstable acute and chronic diseases
- active infection
- history of malignant tumor within 5 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Professor Li, 021-027-84397521
About this study
Official title: A Phase Ib/IIa Clinical Trial Evaluating the Safety, Tolerability, and Efficacy of GR1803 Injection in Subjects With Systemic Lupus Erythematosus
to evaluate the safety and efficacy of GR1803 in the treatment of patients with systemic lupus erythematosus
- Conditions
- Systemic Lupus Erthematosus, Auto Immune Disease
- Being tested
- GR1803 injection
- Keywords
- BCMA/CD3 Bispecific Antibody, systemic lupus erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GR1803 injectionBiological
step-up dosing, Dose and frequency according to the protocol
| Study group | Role | What they receive |
|---|---|---|
| GR1803 injection dose 1 | Experimental | Not described Receives: Biological: GR1803 injection |
| GR1803 injection dose 2 | Experimental | Not described Receives: Biological: GR1803 injection |
| GR1803 injection dose 3 | Experimental | Not described Receives: Biological: GR1803 injection |
| GR1803 injection dose 4 | Experimental | Not described Receives: Biological: GR1803 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of adverse event
incidence of adverse event
Measured: 52 week
Secondary outcomes (1)
efficacy of GR1803
clinical response of SLE
Measured: 52 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start2 Feb 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErthematosusStudies of the same condition, open and under way.
- More trials run by Genrix (Shanghai) Biopharmaceutical 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348055
- Sponsor's protocol ID
- GR1803-007
- Status last verified
- Mar 2026
- First submitted
- 25 Dec 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/IIa Clinical Trial Evaluating the Safety, Tolerability, and Efficacy of GR1803 Injection in Subjects With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07348055
- Acronym / sponsor ID
- GR1803-007
- Conditions
- Systemic Lupus Erthematosus, Auto Immune Disease
- Keywords
- BCMA/CD3 Bispecific Antibody, systemic lupus erythematosus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 16 Jan 2026 (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.
to evaluate the safety and efficacy of GR1803 in the treatment of patients with systemic lupus erythematosus
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GR1803 injection dose 1 | Experimental | Biological: GR1803 injection |
| GR1803 injection dose 2 | Experimental | Biological: GR1803 injection |
| GR1803 injection dose 3 | Experimental | Biological: GR1803 injection |
| GR1803 injection dose 4 | Experimental | Biological: GR1803 injection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- comfirmed diagnosis of systemic lupus erythematosus
- SLEDAI-2K≥6分
- written informed consent and ability to comply with protocol requirements
- have received adequate dose of glucocorticoids, antimalarials, immunosuppressants for 3 months
Key exclusion criteria (3 listed)
- with unstable acute and chronic diseases
- active infection
- history of malignant tumor within 5 years
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 |
|---|---|---|
| GR1803 injectionstep-up dosing, Dose and frequency according to the protocol | Biological | GR1803 injection dose 1, GR1803 injection dose 2, GR1803 injection dose 3, GR1803 injection dose 4 |
Primary outcome
incidence of adverse event
Time frame: 52 week
incidence of adverse event
1 secondary outcome
efficacy of GR1803
Time frame: 52 week
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 10 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GR1803 injection in people with Systemic Lupus Erthematosus and Auto Immune Disease, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Nian (021-50805989-08324, nianhanli@genrixbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of adverse event (time frame: 52 week). 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 10 Mar 2026.