Autoimmune DiseasesEarly Phase 1NCT07246096
Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
A Early Phase 1 study testing anti-CD19/BCMA U CAR T cells in people with Autoimmune Diseases and Systemic Lupus Erythematosus, run by Changhai Hospital at 1 site in China.
Trial summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases. 60 patients are planned to be enrolled in the dose-escalation trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Autoimmune Diseases, Systemic Lupus Erythematosus, Systemic Sclerosis
- What is being tested?
- anti-CD19/BCMA U CAR T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2026to 20 Jul 2028
- Phase
- Early 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects who meet any of the following common exclusion criteria or disease-specific exclusion criteria will not be eligible for this study.
- Common exclusion Criteria:
- Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions;
- Existence or suspicion of uncontrollable or treatable fungal, bacterial, viral or other infections;
- Subjects with central nervous system disorders caused by ADs or not caused by ADs (including epilepsy, psychiatric disorders, organic encephalopathy syndromes, cerebrovascular accidents, encephalitis, central nervous system vasculitis);
- Subjects s with relatively serious heart diseases, such as angina pectoris, myocardial infarction, heart failure, and arrhythmia;
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- Subjects with congenital immunoglobulin deficiency;
- Subjects with malignant tumors (except for non-melanoma skin cancer and in situ cervical, bladder, and breast cancers that have been disease free for more than 5 years);
- Subjects with end-stage renal failure;
- Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis,B core antibody (HBcAb) and HBV DNA titer in peripheral blood higher than the upper limit of detection; Patients with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; People who are positive for human immunodeficiency virus (HIV) antibodies; Those who have tested positive for syphilis;
- Subjects with mental illness and severe cognitive impairment;
- Subjects who have received other clinical trial treatment within 6 months;
- Pregnant or intending to conceive women;
- Subjects with hypertension or diabetes that cannot be controlled by medication;
- In the opinion of the investigator, there are other reasons that prevent some subjects from being included in this study.
- Specific exclusion Criteria:
- Relapsed/Refractory Systemic lupus erythematosus
- Except for SLE, any clinically significant history of cardiac, endocrine, blood, liver, immune, metabolic, urinary, pulmonary, neurological, skin, psychiatric, or renal disorders, or other major diseases that may interfere with the administration of KN3601 (as determined by the investigator);
- Except for SLE, any active skin disease that could interfere with the research evaluation of SLE including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE cutaneous lupus manifestations (such as cutaneous vasculopathy, periungual capillary dilation, fingertip sclerosis, rheumatoid nodules, erythema multiforme, leg ulcers) or drug-induced lupus.
- Relapsed/Refractory Primary Sjögren's Syndrome
- 1. SSc-like disease caused by environmental, ingestion, or injection factors, accompanied by other autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, polymyositis, etc.).
- Relapsed/Refractory dry syndrome
- Combined cirrhosis of the liver;
- Combination of aplastic anemia (AA), myelodysplastic syndrome (MDS), or other myeloproliferative disease (MPD).
- Relapsed/Refractory rheumatoid arthritis
- 1. Functional status of rheumatoid arthritis graded at level 4 according to ACR.
- Relapsed/refractory ANCA-associated vasculitis
- Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2;
- If the patient has alveolar hemorrhage invasive lung ventilation is required, estimated to last longer than the screening period.
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
Changhai Hospital
Shanghai
Dongbao Dongbao Zhao, Doctor, +86-15921061314, dongbaozhao@163.com
About this study
Official title: Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases.
60 patients are planned to be enrolled in the dose-escalation trial.
- Conditions
- Autoimmune Diseases, Systemic Lupus Erythematosus, Systemic Sclerosis, Primary Sjögren Syndrome, Rheumatoid Arthritis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Being tested
- anti-CD19/BCMA U CAR T cells
- Medical subject headings
- Autoimmune Diseases, Lupus Erythematosus, Systemic, Scleroderma, Systemic, Arthritis, Rheumatoid, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19/BCMA U CAR T cellsBiological
Patients will receive Fludarabine and Cyclophosphamide on day-5, -4, and -3. Dose escalation will be performed for the single dose injection of anti-CD19/BCMA CAR T cells (KN3601)
| Study group | Role | What they receive |
|---|---|---|
| KN3601 | Experimental | Not described Receives: Biological: anti-CD19/BCMA U CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicity (DLT)
To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases
Measured: up to 52 weeks after infusion
Incidence of Treatment Emergent Adverse Events (TEAEs)
To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases
Measured: up to 52 weeks after infusion
Secondary outcomes (4)
The overall response rate (ORR)
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases
Measured: up to 52 weeks after infusion
Disease control rate (DCR)
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases
Measured: up to 52 weeks after infusion
B cell depletion rate
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases
Measured: up to 52 weeks after infusion
B cell reconstitution
B cell subsets in peripheral blood measured by flow cytometry
Measured: up to 52 weeks after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start20 Feb 2026 (estimated)
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rui Therapeutics Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246096
- Sponsor's protocol ID
- CHEC2025-363
- Status last verified
- Sep 2025
- First submitted
- 14 Nov 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07246096
- Acronym / sponsor ID
- CHEC2025-363
- Conditions
- Autoimmune Diseases, Systemic Lupus Erythematosus, Systemic Sclerosis, Primary Sjögren Syndrome, Rheumatoid Arthritis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Rui Therapeutics Co., Ltd
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Jul 2028 (estimated)
- First posted
- 24 Nov 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.
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases.
60 patients are planned to be enrolled in the dose-escalation trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KN3601 | Experimental | Biological: anti-CD19/BCMA U CAR T cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (29 listed)
- Subjects who meet any of the following common exclusion criteria or disease-specific exclusion criteria will not be eligible for this study.
- Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions;
- Existence or suspicion of uncontrollable or treatable fungal, bacterial, viral or other infections;
- Subjects with central nervous system disorders caused by ADs or not caused by ADs (including epilepsy, psychiatric disorders, organic encephalopathy syndromes, cerebrovascular accidents, encephalitis, central nervous system vasculitis);
- Subjects s with relatively serious heart diseases, such as angina pectoris, myocardial infarction, heart failure, and arrhythmia;
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 |
|---|---|---|
| anti-CD19/BCMA U CAR T cellsPatients will receive Fludarabine and Cyclophosphamide on day-5, -4, and -3. Dose escalation will be performed for the single dose injection of anti-CD19/BCMA CAR T cells (KN3601) | Biological | KN3601 |
Primary outcome
Incidence of Dose-Limiting Toxicity (DLT)
Time frame: up to 52 weeks after infusion
To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: up to 52 weeks after infusion
To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases
4 secondary outcomes
The overall response rate (ORR)
Time frame: up to 52 weeks after infusion
Disease control rate (DCR)
Time frame: up to 52 weeks after infusion
B cell depletion rate
Time frame: up to 52 weeks after infusion
B cell reconstitution
Time frame: up to 52 weeks after 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 25 Feb 2026.
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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 Early Phase 1 study testing anti-CD19/BCMA U CAR T cells in people with Autoimmune Diseases and Systemic Lupus Erythematosus, run by Changhai Hospital 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 0 inclusion and 29 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 25 Feb 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Dongbao Zhao (+86-15921061314, dongbaozhao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicity (DLT) (time frame: up to 52 weeks after infusion). 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 Feb 2026.