Systemic Lupus Erythematosus (SLE)Phase 1NCT07829614
F182112 Phase Ib Clinical Study for the Treatment of Patients With Systemic Lupus Erythematosus
A Phase 1 study testing F182112 in people with Systemic Lupus Erythematosus (SLE), run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
Trial summary
The investigational drug is an injectable recombinant humanized anti-BCMA/CD3 bispecific antibody (code: F182112) that can simultaneously target the immune effector cell antigen CD3 and the antigen BCMA. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- F182112
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2025to 31 Dec 2027
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years, any gender;
- Diagnosed with systemic lupus erythematosus (SLE) ≥12 weeks according to the classification criteria established by the 2019 European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR);
- Able to understand the trial procedures and content, and voluntarily sign the informed consent form.
Who cannot join
- Previously received BCMA-targeted therapy;
- Received any B-cell depletion therapy (such as anti-CD20, anti-CD19, etc.) or anti-plasma cell therapy within 6 months before starting the drug or within 5 half-lives (whichever is longer);
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
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
JZhang, 0539-8330397, lnzylcyj666@126.com
About this study
Official title: Phase Ib Clinical Study Evaluating the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, and Immunogenicity of F182112 in Patients With Systemic Lupus Erythematosus
The investigational drug is an injectable recombinant humanized anti-BCMA/CD3 bispecific antibody (code: F182112) that can simultaneously target the immune effector cell antigen CD3 and the antigen BCMA. Through a dual-targeting mechanism, it aims to guide the body's own immune system to target and kill B cells and plasma cells that overexpress BCMA.Based on the application of B cell depletion strategies in the treatment of autoimmune diseases, as well as the exploration of similar drugs in autoimmune diseases, we speculate that F182112 is also effective for autoimmune diseases. Therefore, we plan to carry out clinical research of F182112 in patients with systemic lupus erythematosus, with the aim of bringing more treatment options to patients.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- F182112
- 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.
F182112Drug
F182112 Dose Escalation and Dose Expansion
| Study group | Role | What they receive |
|---|---|---|
| F182112 Phase Ⅰb Clinical Study in the Treatment of Patients with Systemic Lupus Erythematosus | Experimental | Not described Receives: Drug: F182112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Adverse Events (AE), Serious Adverse Events (SAE)
Measured: During the period of dose-limiting toxicity observation (within 28 days after the first administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start30 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 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 Erythematosus (SLE)Studies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829614
- Sponsor's protocol ID
- NTP-F182112-002
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Clinical Study Evaluating the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, and Immunogenicity of F182112 in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07829614
- Acronym / sponsor ID
- NTP-F182112-002
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Sep 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.
The investigational drug is an injectable recombinant humanized anti-BCMA/CD3 bispecific antibody (code: F182112) that can simultaneously target the immune effector cell antigen CD3 and the antigen BCMA. Through a dual-targeting mechanism, it aims to guide the body's own immune system to target and kill B cells and plasma cells that overexpress BCMA.Based on the application of B cell depletion strategies in the treatment of autoimmune diseases, as well as the exploration of similar drugs in autoimmune diseases, we speculate that F182112 is also effective for autoimmune diseases. Therefore, we plan to carry out clinical research of F182112 in patients with systemic lupus erythematosus, with the aim of bringing more treatment options to patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F182112 Phase Ⅰb Clinical Study in the Treatment of Patients with Systemic Lupus Erythematosus | Experimental | Drug: F182112 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years, any gender;
- Diagnosed with systemic lupus erythematosus (SLE) ≥12 weeks according to the classification criteria established by the 2019 European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR);
- Able to understand the trial procedures and content, and voluntarily sign the informed consent form.
Key exclusion criteria (2 listed)
- Previously received BCMA-targeted therapy;
- Received any B-cell depletion therapy (such as anti-CD20, anti-CD19, etc.) or anti-plasma cell therapy within 6 months before starting the drug or within 5 half-lives (whichever is longer);
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 |
|---|---|---|
| F182112F182112 Dose Escalation and Dose Expansion | Drug | F182112 Phase Ⅰb Clinical Study in the Treatment of Patients with Systemic Lupus Erythematosus |
Primary outcome
The Incidence of Adverse Events (AE), Serious Adverse Events (SAE)
Time frame: During the period of dose-limiting toxicity observation (within 28 days after the first administration)
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 21 Sep 2026.
- Individual participant dataSharing planned: No
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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 study testing F182112 in people with Systemic Lupus Erythematosus (SLE), run by Shandong New Time Pharmaceutical 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 3 inclusion and 2 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 21 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 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 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.
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 BAO (13601689747, baochunde_1678@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Adverse Events (AE), Serious Adverse Events (SAE) (time frame: During the period of dose-limiting toxicity observation (within 28 days after the first administration)). 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 21 Sep 2026.