AzTrials
AzTrials

Autoimmune DiseasesPhase 1/2NCT07161193

Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases

A Phase 1/2 study testing CD19 CAR-T cells in people with Autoimmune Diseases, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Autoimmune Diseases
What is being tested?
CD19 CAR-T cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
30 Sep 2025to 18 Nov 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Refractory Moderate-to-Severe Systemic lupus erythematosus (SLE) 1.1.Age 18-70 years. 1.2.Estimated life expectancy ≥ 3 months. 1.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 1.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
  • 1.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
  • 1.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.
  • 1.7.Required laboratory tests, including but not limited to: CBC, urinalysis, ANA, anti-dsDNA, ENA panel, C3/C4, immunoglobulins, antiphospholipid antibodies, etc.
  • 1.8.Meets current international or domestic classification criteria: the 1997 ACR SLE classification criteria OR the 2019 EULAR/ACR SLE classification criteria, and is judged to have moderate-to-severe SLE.
  • 1.9.SELENA-SLEDAI score ≥ 8; PGA ≥ 1; and at least one BILAG-2004 organ-system score of 1A or 2B.
Show all 45Show fewer
  • 1.10.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.
  • 2.Refractory Idiopathic inflammatory myopathy (IIM) 2.1.Age 18-70 years. 2.2.Estimated life expectancy ≥ 3 months. 2.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 2.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
  • 2.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
  • 2.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.
  • 2.7.Fulfillment of the 2017 EULAR/ACR classification criteria for dermatomyositis or polymyositis.
  • 2.8.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.
  • 3.Refractory Systemic sclerosis (SSc) 3.1.Age 18-70 years. 3.2.Estimated life expectancy ≥ 3 months. 3.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 3.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
  • 3.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
  • 3.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.
  • 3.7.Fulfillment of the 2013 ACR/EULAR classification criteria for systemic sclerosis, with clinical or radiographic evidence of pulmonary involvement.
  • 3.8.Required laboratory tests, including but not limited to: CBC, urinalysis, ANA, anti-dsDNA, ENA panel, C3/C4, immunoglobulins, etc.
  • 3.9.Classification per current international or domestic standards: the 1980 ACR criteria for SSc OR the 2013 ACR/EULAR criteria for SSc.
  • 3.10.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.
  • 4.Refractory Pemphigus 4.1.Age 18-70 years. 4.2.Estimated life expectancy ≥ 3 months. 4.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 4.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
  • 4.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
  • 4.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.
  • 4.7.Fulfillment of at least one clinical manifestation plus one histopathological or immunodiagnostic criterion, OR at least two clinical manifestations plus two immunodiagnostic criteria:
  • Clinical manifestations: flaccid cutaneous bullae and fragile blisters that rupture easily, resulting in persistent erosions; mucosal blisters or erosions; positive Nikolsky sign.
  • Histopathology: intraepidermal or intraepithelial acantholysis.
  • Immunodiagnostic criteria: direct immunofluorescence (DIF) showing intercellular IgG and/or complement deposition in epidermal/epithelial cells of lesional or perilesional normal skin; positive serum anti-epithelial cell antibodies by indirect immunofluorescence; positive serum anti-desmoglein antibodies by ELISA.
  • 4.8.Pemphigus Disease Area Index (PDAI) ≥ 9 (moderate 9-24, severe ≥ 25). 4.9.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.
  • 5.Refractory Moderate-to-Severe Psoriasis 5.1.Age 18-70 years. 5.2.Estimated life expectancy ≥ 3 months. 5.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 5.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
  • 5.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
  • 5.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.
  • 5.7.In accordance with the 2023 Chinese Guidelines for the Diagnosis and Treatment of Psoriasis, meets the diagnostic criteria for moderate-to-severe plaque psoriasis: dark-red or infiltrated erythematous plaques covered by white/silvery scales, demonstrating the wax-drip, film, and Auspitz signs.
  • 5.8.At screening: Body Surface Area (BSA) involvement ≥ 10%, Psoriasis Area and Severity Index (PASI) ≥ 10, and static Physician's Global Assessment (sPGA) ≥ 3.
  • 5.9.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.
  • 6.Refractory Moderate-to-Severe Rheumatoid Arthritis 6.1.Age 18-70 years. 6.2.Estimated life expectancy ≥ 3 months. 6.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 6.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
  • 6.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
  • 6.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.
  • 6.7.Required laboratory and imaging assessments, including but not limited to: ESR, CRP, rheumatoid factor, ANA, anti-CCP antibodies, and other relevant autoantibodies; bilateral hand/foot radiographs.
  • 6.8.Meets current international or domestic classification criteria: the 1987 ACR criteria for RA OR the 2010 ACR/EULAR criteria for RA.
  • 6.9.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.
  • 7.Refractory ANCA-Associated Vasculitis/Nephritis 7.1.Age 18-70 years. 7.2.Estimated life expectancy ≥ 3 months. 7.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 7.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
  • 7.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
  • 7.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.
  • 7.7.Meets the 2022 ACR/EULAR classification criteria for vasculitis. 7.8.Renal biopsy indicating kidney involvement, or clinical manifestations consistent with small-vessel vasculitis together with positive myeloperoxidase (MPO) or proteinase-3 (PR3) antibodies.
  • 7.9.Persistent or newly emerging renal and/or systemic vasculitic manifestations despite maintenance therapy of the same intensity as initial immunosuppressive treatment.
  • 7.10.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.

Who cannot join

  • (1) Clinically significant (as determined by the investigator) history of cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases.
  • Pregnant or lactating women. (3) History of active tuberculosis (TB) infection within 3 years prior to the screening visit.
  • History of traumatic brain injury, altered consciousness, epilepsy, cerebral ischemia, or any cerebrovascular hemorrhagic disorders.
  • Prolonged QT interval on ECG or history of severe arrhythmias or other significant cardiac disorders.
  • Active infection (excluding uncomplicated urinary tract infection and bacterial pharyngitis).
  • Active hepatitis B virus or hepatitis C virus infection. (8) Confirmed positive anti-HIV antibody test. (9) Positive Treponema pallidum antibody test judged by the investigator to be clinically significant.
Show all 10Show fewer
  • Any known or suspected congenital or acquired immunodeficiency that may compromise the subject's immune status.
  • Prior treatment with CD19 CAR-T cell therapy or CD19-targeted antibody drugs.
  • Prior exposure to any gene therapy. (13) ALT/AST > 3× ULN, or bilirubin > 2.0× ULN, or serum creatinine > 2× ULN, or creatinine clearance < 30 mL/min.
  • Any condition that, in the opinion of the investigator, may increase patient risk or interfere with study results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huirui Wang, M.D. contact

+86-0379-63307832

wanghuirui7873@163.com

Songyun Wang, M.D. contact

15237998132@163.com

China1 site

  • Henan Province Engineering Technology Research Center of Immunological Precision Medicine and Artificial Intelligence Application, The Second Affiliated Hospital of Henan University of Science and Technology, Luoyang, China

    Luoyang, Henan, 471003

    Huirui Wang, M.D., +86-0379-63307832, wanghuirui7873@163.com

    Songyun Wang, M.D., 15237998132@163.com

Other trials in China

About this study

The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases

Read the detailed description

This is a single-center, open-label, single-arm, dose-escalation trial. In this study, we will recruit seven kinds of refractory autoimmune diseases including moderate-to-severe Systemic lupus erythematosus (SLE), refractory Pemphigus, refractory Idiopathic inflammatory myopathy (IIM), Systemic sclerosis (SSc), Refractory ANCA-Associated Vasculitis/Nephritis,refractory Rheumatoid arthritis(RA) and moderate-to-severe refractory Psoriasis.

Patients with Refractory Autoimmune Diseases will receive CD19 CAR T cells. The primary objective is to evaluate the safety and efficacy of CD19 CAR T cell therapy in subjects with Refractory Autoimmune Diseases and to determine the optimal biological dose (OBD) in phase I and to learn about the efficacy CD19 CAR T-cell therapy in patients with Refractory Autoimmune Diseases in phase II.

The primary endpoint is to evaluate the incidence and severity of cytokine release syndrome and severe neurotoxic adverse events within 28 days after CAR-T cell infusion.A total number of 3o subjects will be enrolled.

Being tested
CD19 CAR-T cells
Keywords
Autoimmune Diseases
Medical subject headings
Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD19 CAR-T cellsBiological

    Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.

Study groups in NCT07161193
Study groupRoleWhat they receive
Experimental :CD19 CARExperimentalFollowing the lymphodepleting treatment, patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.
Receives: Biological: CD19 CAR-T cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I:Cytokine Release Syndrome (CRS)

    The incidence and severity of Cytokine Release Syndrome (CRS)

    Measured: 28 days post infusion

  2. Phase I：Immune Effector Cell-Associated Neurotoxicity Syndrome(ICANS)

    The incidence and severity of Immune Effector Cell-Associated Neurotoxicity Syndrome(ICANS)

    Measured: 28 days post infusion

  3. Phase II: Efficacy:Objective response rate (ORR)

    Proportions of subjects achieving Autoimmune Diseases response

    Measured: 3 months and 6 months post infusion

Secondary outcomes (14)

  1. AUCS of CAR-T cells [Cell dynamics]

    AUCS is defined as the area under the curve in 6 months

    Measured: Up to 6 months post infusion

  2. CMAX of CD19 CAR T cells [Cell dynamics]

    CMAX is defined as the highest concentration of CD19 CAR T cells expanded in peripheral blood

    Measured: Up to 6 months post infusion

  3. TMAX of CD19 CAR T cells [Cell dynamics]

    TMAX is defined as the time to reach the highest concentration

    Measured: Up to 6 months post infusion

  4. CAR-T proliferation [Cell dynamics]

    the copy number of Senl CAR- T cells in the genomes of PBMC by qPCR method

    Measured: Up to 6 months post infusion

  5. Pharmacodynamics of CD19 CAR T cells

    IL-6 levels measured by Chemiluminescence method

    Measured: Up to 6 months post infusion

  6. B cell levels in peripheral blood

    The change of B cell levels in peripheral blood after infusion

    Measured: Up to 6 months post infusion

  7. SLE:Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K)

    The Change of Systemic Lupus Erythematosus Diseases Activity Index, (SLEDAI-2k) from baseline.

    Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) helped standardize outcome measures in SLE and is a clinical tool predominantly used in research to track disease activity and response to therapy.

    SLEDAI score (obtained by adding the individual 24 item scores) ranges from 0 to 105, where the higher the score, the greater the degree of disease activity.

    No Flare (Disease no active): 0-3 Mild or moderate flare ( Mild or moderate Active): 4-12 Severe Flare (Severe Active): ≥ 13

    Measured: Up to 6 months post infusion

  8. IIM:Remission Rate

    Per the International Myositis Assessment and Clinical Studies Group (IMACS) criteria, complete remission is defined as normalization of all activity measures with no new symptoms, whereas partial remission is defined as improvement of ≥50 % of the baseline abnormal measures.

    Measured: Up to 6 months post infusion

  9. SSc:modified Rodnan Skin Score (mRSS)

    Skin improvement will be assessed using the modified Rodnan Skin Score (mRSS). A clinically significant improvement is defined as a ≥5-point absolute decrease or a ≥25 % relative reduction from baseline; stability is defined as a change of ≤3 points.

    Measured: Up to 6 months post infusion

  10. SSc: Pulmonary fibrosis progression

    Pulmonary fibrosis progression is defined as a ≥10 % decline in percent-predicted FVC and/or a ≥15 % decline in percent-predicted DLCO, or evidence of progressive fibrosis on high-resolution chest CT.

    Measured: Up to 6 months post infusion

  11. Pemphigus:Pemphigus Disease Area Index (PDAI).

    Disease activity will be assessed with the Pemphigus Disease Area Index (PDAI).

    • Complete remission: PDAI = 0 and no new blisters.
    • Partial remission: ≥ 75 % reduction in PDAI from baseline.
    • Treatment failure: < 50 % reduction in PDAI from baseline or appearance of new blisters.

    Measured: Up to 6 months post infusion

  12. Psoriasis:Psoriasis Area and Severity Index (PASI)

    In accordance with the 2023 Chinese Guidelines for the Diagnosis and Treatment of Psoriasis, treatment response will be evaluated using the Psoriasis Area and Severity Index (PASI)

    • Complete clearance: 100 % improvement in PASI.
    • Almost complete clearance: 90 - 100 % improvement in PASI.
    • Effective response: 75 - 90 % improvement in PASI.
    • Treatment failure: ≤ 50 % improvement in PASI.

    Measured: Up to 6 months post infusion

  13. RA:IIM:Remission Rate

    Rheumatoid arthritis: Response will be assessed using ACR, EULAR, SDAI, and CDAI criteria, with the goal of achieving disease remission or a response at least equivalent/superior to that afforded by conventional therapy.

    Measured: Up to 6 months post infusion

  14. ANCA-associated vasculitis/nephritis:Birmingham Vasculitis Activity Score (BVAS)

    ANCA-associated vasculitis/nephritis: According to the 2024 KDIGO Clinical Practice Guideline for the Management of ANCA-Associated Vasculitis, disease outcomes will be evaluated with the Birmingham Vasculitis Activity Score (BVAS). Remission is defined as the absence of active vasculitis and glomerulonephritis (BVAS = 0), and relapse is defined as renewed disease activity after partial or complete remission.

    Measured: Up to 6 months post infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2025
  2. Study start30 Sep 2025 (estimated)
  3. Primary completion18 Aug 2027 (estimated)
  4. Study completion18 Nov 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07161193
Sponsor's protocol ID
L2025021-2
Status last verified
Sep 2025
First submitted
19 Aug 2025
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CD19 CAR-T cells in people with Autoimmune Diseases, run by Hebei Senlang Biotechnology Inc., 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 45 inclusion and 10 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: opening soon, as of the sponsor's last update on 8 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 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 Huirui Wang, M.D. (+86-0379-63307832, wanghuirui7873@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I:Cytokine Release Syndrome (CRS) (time frame: 28 days post infusion). The study lists 3 primary outcomes in all. 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 NCT07161193.

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 8 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in