Systemic Lupus ErythematosusPhase 1NCT06400537
Clinical Study of A-319 in the Treatment of Active/Refractory Systemic Lupus Erythematosus
A Phase 1 study testing A-319 in people with Systemic Lupus Erythematosus, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 sites in China.
Trial summary
The purpose of the study is to explore the safety and efficacy of recombinant CD19xCD3 double antibody (A-319) in active/refractory systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- A-319
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesChina
- Study dates
- 20 Jul 2024to Dec 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years old, regardless of gender;
- Participants diagnosed with SLE according to the American College of Rheumatology (ACR) 1997 revised criteria for SLE at least 24 weeks prior to signing the informed consent form;
- Active/refractory systemic lupus erythematosus;
- Positive test results for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) immunofluorescence assay at a titer of ≥1:80; anti-dsDNA; or anti-Smith (anti-Sm);
- Receive the standardized and stable treatment for at least 30 days before the first administration of the study drug;
- Female participants tested negative for pregnancy, and participants agreed to use effective contraception throughout the trial;
- Have the ability to understand the nature of the research and voluntarily sign an informed consent form;
- Participants can communicate well with the researchers and complete all visits according to the requirements of the plan.
Who cannot join
- Severe kidney disease;
- Participants who have central nervous system diseases caused by SLE or non-SLE disease within 8 weeks before the first administration of the study drug;
- Abnormities of main organ function at screening;
- Medical history that the researchers believe will pose risk to the safety of the participants, or will affect the safety or effectiveness analysis of the study drug;
- Active mycobacterium tuberculosis infection;
- Active hepatitis, or hepatitis B virus surface antigen positive, or hepatitis B virus core antibody positive and hepatitis B virus deoxyribonucleic acid positive, ,or hepatitis C virus (HCV) antibody positive with detectable HCV ribonucleic acid (RNA).;
Show all 21Show fewer
- History of human immunodeficiency virus infection, or positive antibodies at screening;
- Positive syphilis spirochete antibody at screening (except false positive caused by SLE);
- Participants with chronic active infection or acute infection need systemic anti-infection treatment within 2 weeks before screening, or have superficial skin infection requiring treatment within 1 week before screening;
- Have undergone major surgery or unhealed wounds, ulcers or fractures within 4 weeks before the first administration of the study drug, or plan to perform major surgery during the study period;
- Participants diagonosed with malignant tumors within 5 years before screening;
- History of important organ transplantation or hematopoietic stem cells/or bone marrow transplantation;
- Have been vaccinated or plan to receive live vaccine or live attenuated vaccine during the research period within 4 weeks before the first administration of the study drug;
- Participated in any clinical trial within 4 weeks before the first administration of the study drug or within 5 half-lives of the study drug of the clinical trial;
- Received targeted drugs (rituximab, JAK inhibitors, etc.) at a specific time period before the first administration of the study drug;
- Received intravenous immunoglobulin, prednisone ≥100mg/d or equivalent glucocorticoid therapy within 4 weeks before the first administration of the study drug, or plasma replacement;
- Received IL-2, thalidomide, rethidone and traditional Chinese medicine within 4 weeks before the first administration of the study drug;
- Known allergies to monoclonal antibody drugs, or allergies to A-319 excipients;
- Participants with depression or suicidal thoughts;
- Women who are pregnant or breastfeeding, or women who plan to be pregnant or breastfeeding during the study period; or men whose sexual partners plan to become pregnant during the study period;
- Any reason that the researchers believe will hinder the subject's participation in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Liyun Zhang, Professor, 1315710223@qq.com
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430000
Qiubai Li, Professor, 85726808 ext. 027, qiubaili@hust.edu.cn
Chunli Mei, PhD, 85726808 ext. 027
About this study
Official title: Clinical Study of Recombinant CD19xCD3 Double Antibody (A-319) in the Treatment of Active/Refractory Systemic Lupus Erythematosus
The purpose of the study is to explore the safety and efficacy of recombinant CD19xCD3 double antibody (A-319) in active/refractory systemic lupus erythematosus (SLE).
Read the detailed description
The pathogenic B cells of patients with SLE can produce a large amount of autoantibodies, which will form immune complexes and thereby inducing continuously expanding tissue damage and systemic inflammation. A-319 is a kind of recombinant CD19xCD3 double antibody, it can activate internal T cells to target and kill pathogenic B cells. Clinical trials of A-319 are currently underway in hematological maliganancies concerning B cell abnormality. Preclinical studies have shown the efficacy of A-319 in SLE. The aim of this study is to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and preliminary efficacy of A-319 in active/refractory SLE. Patients with active/refractory SLE will be invited to participate in the study, to receive A-319 intravenous infusion or subcutaneous injection and follow-up visits of up to 1 years after enrollment.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- A-319
- Keywords
- systemic lupus erythematosus, A-319
- 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.
A-319Biological
A-319 will be dosed according to the assigned group.
| Study group | Role | What they receive |
|---|---|---|
| A-319 intravenous intervention | Experimental | A-319 will be preset with 3 escalation dose levels by intravenous infusion: dose A, dose B, dose C, total course of treatment: 4 weeks. Anticipated enrollment: 9-18 participants. Receives: Biological: A-319 |
| A-319 subcutaneous intervention | Experimental | A-319 will be administered via subcutaneous injection at five preset escalating dose levels: Dose A, Dose B, Dose C, Dose D, and Dose E. The total treatment duration is 4 weeks. Each dose group is planned to enroll 3+N (N=0-12) participants, with a total anticipated enrollment of 16-32 study participants. Receives: Biological: A-319 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Safety and tolerability will be assessed by incidence and severity of adverse events (AEs) and serious AEs (SAEs)
Measured: Within 1 year since A-319 infusion
Secondary outcomes (4)
Pharmacokinetics of A-319
Concentration of A-319 in peripheral blood will be evaluated
Measured: Within 1 month since A-319 infusion
Pharmacodynamics of A-319
Pharmacodynamics will be assessed by levels of cytokines (IL-6, IL-8, IL-10, IFN-γ, TNF-α) in peripheral blood
Measured: Within 1 month since A-319 infusion
Pharmacodynamics of A-319
Pharmacodynamics will be assessed by levels of lymphocyte subsets in peripheral blood
Measured: Within 1 month since A-319 infusion
Numbers of Participants with positive antidrug antibodies in peripheral blood
To evaluate immunogenicity of A-319
Measured: Day 28 and month 3 since A-319 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start20 Jul 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ITabMed Co., Ltd.
- Responsible party
- Principal investigator, Qiubai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Qiubai Li, Professor, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400537
- Sponsor's protocol ID
- UHCT240243
- Status last verified
- Sep 2025
- First submitted
- 1 May 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu J, Mei C, Guan X, Du R, Wu B, Wu D, Li M, Li J, Song Y, Su H, Chen X, Guo Q, Chen H, Sussman JH, Chen GM, Bandyopadhyay S, Pillai V, Lanz TV, Liedtke M, Onel K, Katsumoto TR, Tan K, Yan X, Chien M, Salmasi G, Kerschbaumer A, Teachey DT, Meffre E, Kennedy VE, Robinson WH, Huang A, Baker MC, Li Q. A bispecific CD3xCD19 antibody for systemic lupus erythematosus: a phase 1 trial. Nat Med. 2026 Sep 10. doi: 10.1038/s41591-026-04572-7. Online ahead of print.
PubMed 42722888
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Recombinant CD19xCD3 Double Antibody (A-319) in the Treatment of Active/Refractory Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06400537
- Acronym / sponsor ID
- UHCT240243
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- systemic lupus erythematosus, A-319
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- ITabMed Co., Ltd.
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 May 2024 (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 purpose of the study is to explore the safety and efficacy of recombinant CD19xCD3 double antibody (A-319) in active/refractory systemic lupus erythematosus (SLE).
Detailed description
The pathogenic B cells of patients with SLE can produce a large amount of autoantibodies, which will form immune complexes and thereby inducing continuously expanding tissue damage and systemic inflammation. A-319 is a kind of recombinant CD19xCD3 double antibody, it can activate internal T cells to target and kill pathogenic B cells. Clinical trials of A-319 are currently underway in hematological maliganancies concerning B cell abnormality. Preclinical studies have shown the efficacy of A-319 in SLE. The aim of this study is to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and preliminary efficacy of A-319 in active/refractory SLE. Patients with active/refractory SLE will be invited to participate in the study, to receive A-319 intravenous infusion or subcutaneous injection and follow-up visits of up to 1 years after enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-319 intravenous intervention | Experimental | Biological: A-319A-319 will be preset with 3 escalation dose levels by intravenous infusion: dose A, dose B, dose C, total course of treatment: 4 weeks. Anticipated enrollment: 9-18 participants. |
| A-319 subcutaneous intervention | Experimental | Biological: A-319A-319 will be administered via subcutaneous injection at five preset escalating dose levels: Dose A, Dose B, Dose C, Dose D, and Dose E. The total treatment duration is 4 weeks. Each dose group is planned to enroll 3+N (N=0-12) participants, with a total anticipated enrollment of 16-32 study participants. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18-60 years old, regardless of gender;
- Participants diagnosed with SLE according to the American College of Rheumatology (ACR) 1997 revised criteria for SLE at least 24 weeks prior to signing the informed consent form;
- Active/refractory systemic lupus erythematosus;
- Positive test results for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) immunofluorescence assay at a titer of ≥1:80; anti-dsDNA; or anti-Smith (anti-Sm);
- Receive the standardized and stable treatment for at least 30 days before the first administration of the study drug;
Key exclusion criteria (21 listed)
- Severe kidney disease;
- Participants who have central nervous system diseases caused by SLE or non-SLE disease within 8 weeks before the first administration of the study drug;
- Abnormities of main organ function at screening;
- Medical history that the researchers believe will pose risk to the safety of the participants, or will affect the safety or effectiveness analysis of the study drug;
- Active mycobacterium tuberculosis infection;
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 |
|---|---|---|
| A-319A-319 will be dosed according to the assigned group. | Biological | A-319 intravenous intervention, A-319 subcutaneous intervention |
Primary outcome
Safety and tolerability
Time frame: Within 1 year since A-319 infusion
Safety and tolerability will be assessed by incidence and severity of adverse events (AEs) and serious AEs (SAEs)
4 secondary outcomes
Pharmacokinetics of A-319
Time frame: Within 1 month since A-319 infusion
Pharmacodynamics of A-319
Time frame: Within 1 month since A-319 infusion
Pharmacodynamics of A-319
Time frame: Within 1 month since A-319 infusion
Numbers of Participants with positive antidrug antibodies in peripheral blood
Time frame: Day 28 and month 3 since A-319 infusion
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 17 Sep 2025.
- Derived from this study: PubMed 42722888Xu J, Mei C, Guan X, Du R, Wu B, Wu D, Li M, Li J, Song Y, Su H, Chen X, Guo Q, Chen H, Sussman JH, Chen GM, Bandyopadhyay S, Pillai V, Lanz TV, Liedtke M, Onel K, Katsumoto TR, Tan K, Yan X, Chien M, Salmasi G, Kerschbaumer A, Teachey DT, Meffre E, Kennedy VE, Robinson WH, Huang A, Baker MC, Li Q. A bispecific CD3xCD19 antibody for systemic lupus erythematosus: a phase 1 trial. Nat Med. 2026 Sep 10. doi: 10.1038/s41591-026-04572-7. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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.
Qiubai Li, Professor principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A-319 in people with Systemic Lupus Erythematosus, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 8 inclusion and 21 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 17 Sep 2025. 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 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 Qiubai Li, Professor (85726808 ext. 027, qiubaili@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: Within 1 year since A-319 infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06400537, which also lists 1 linked publication.
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 17 Sep 2025.