ClinicalTrials.gg
RecruitingNCT07348055Updated Mar 10, 2026

A Study of GR1803 in Systemic Lupus Erythematosus

A Phase 1/2 interventional study of GR1803 injection in Systemic Lupus Erthematosus and Auto Immune Disease, sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd. (part of Chongqing Genrix Biopharmaceutical Co., Ltd) · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 1/2
Study type
Interventional
Enrollment
44
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 266 studies in Lupus Erythematosus, Systemic with a site in China — 168 open to participants now, 191 under way, 22 of them phase 3. Lupus Erythematosus, Systemic · China.

Planned enrollment
111th of 245
44 · median 36
Started
2026
with 55 others
Phase 1/2
19 of 266
13 open now
Primary completion
2027-06
later than 103 of 190 live
Registered
218th of 266
by date

Among the 266 studies in Lupus Erythematosus, Systemic with a site in China, this one is the 111th largest by planned enrollment of the 245 interventional ones that give a count, is one of 56 that started in 2026, is one of 19 in phase 1/2, reaches primary completion later than 103 of the 190 other live ones, and was the 218th registered.

Lupus Erythematosus, Systemic

1,210 studies on the registry are indexed under Lupus Erythematosus, Systemic; 406 are open to participants now.

Browse Lupus Erythematosus, Systemic studies →

Open to participants now

168 of the 266 studies in Lupus Erythematosus, Systemic with a site in China are open now. Recruiting first, the newest first:

163 more — sign in →

All 168 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 284 Lupus Erythematosus, Systemic studies recruiting now, 93 (33%) set no upper age limit and 161 (57%) stop at 75 or younger; 54 take children under 18; 33 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 266 studies in Lupus Erythematosus, Systemic with a site in China, or all of them as a file.
02

Study summary

to evaluate the safety and efficacy of GR1803 in the treatment of patients with systemic lupus erythematosus

03

Conditions studied

  • Systemic Lupus Erthematosus
  • Auto Immune Disease

Keywords

  • BCMA/CD3 Bispecific Antibody
  • systemic lupus erythematosus
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • comfirmed diagnosis of systemic lupus erythematosus
  • SLEDAI-2K≥6分
  • written and ability to comply with protocol requirements
  • have received adequate dose of , antimalarials, for 3 months

Exclusion criteria

Exclusion Criteria:

  • with unstable acute and chronic diseases
  • active infection
  • history of malignant tumor within 5 years
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    GR1803 injection dose 1

    Biological: GR1803 injection

  • Experimental
    GR1803 injection dose 2

    Biological: GR1803 injection

  • Experimental
    GR1803 injection dose 3

    Biological: GR1803 injection

  • Experimental
    GR1803 injection dose 4

    Biological: GR1803 injection

Interventions

  • step-up dosing, Dose and frequency according to the protocol

06

What researchers measure

Primary outcomes

  1. incidence of adverse event

    incidence of adverse event

    Time frame: 52 week

Secondary outcomes

  1. efficacy of GR1803

    clinical response of SLE

    Time frame: 52 week

07

Study locations

1 of 1 sites recruiting
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430000, China
    Recruiting
    • Professor Li · Contact021-027-84397521
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Jun 2027, 15 months after the start.

Of 37 phase 1/2 interventional studies under Lupus Erythematosus, Systemic, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 60. This study's planned 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 25, 2025
First posted
Jan 16, 2026
StartActual
Feb 2, 2026
Primary completionEst.
Jun 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Mar 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07348055
Responsible party
Sponsor
First posted
Jan 16, 2026
Start date
Feb 2, 2026
Primary completion
Jun 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Mar 10, 2026

Study contacts

Nian
Contact
nianhanli@genrixbio.com
021-50805989-08324

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: GR1803

Start the discussion