Systemic Lupus ErythematosusPhase 1NCT06222853
Study of Therapeutic Efficacy of Anti-CD19 CAR-T Cells in Refractory Systemic Lupus Erythematosus
A Phase 1 study testing anti-CD19-CAR-T cells in people with Systemic Lupus Erythematosus and CAR-T Cell Therapy, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
This is an investigator-initiated trial aimed at assessing the safety of anti-CD19 CAR-T cells in the treatment of refractory systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, CAR-T Cell Therapy
- What is being tested?
- anti-CD19-CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2024to 30 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: ≥5 years old.
- Refractory SLE Diagnosis:
- Diagnosed with SLE according to the 2019 EULAR/ACR classification criteria.
- Exhibit persistent moderate to severe disease activity (defined as a SLEDAI-2K score ≥ 8).
- Demonstrated failure or to achieve target disease control (LLDAS or remission) after a minimum of 6 months of standard-of-care therapy, including: high doses of glucocorticoids (≥1mg/kg/day prednisone or equivalent), hydroxychloroquine, and at least two DMARDs (including cyclophosphamide, MMF, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, tocilizumab, belimumab, and rituximab) for at least 6 months; or intolerant to conventional treatments.
- Note: Patients may also be eligible if they are documented as intolerant to these conventional treatments.
Show all 17Show fewer
- Disease Severity Validation: To ensure a "refractory" status, patients must satisfy at least one of the following:
- Active Major Organ Involvement (e.g., biopsy-proven Lupus Nephritis Class III, IV, or V; CNS lupus; or refractory hematological cytopenias).
- Steroid Dependence: Inability to taper glucocorticoid dose below 0.5 mg/kg/day (or equivalent) without a disease flare.
- Organ Function:
- Cardiac: LVEF ≥ 55 %, with no significant clinical abnormalities on ECG.
- Renal: Estimated glomerular filtration rate (eGFR) 30 mL/min/1.73m2.
- Liver: AST and ALT ≤ 3.0 ULN, and total bilirubin ≤ 2.0 ULN.
- Pulmonary: No severe lung disease, with oxygen saturation (SpO2) ≥ 92% on room air.
- Apheresis Suitability: Must meet institutional criteria for leukapheresis and have no contraindications to peripheral blood mononuclear cell (PBMC) collection.
- Contraception: Females of childbearing age must have a negative urine pregnancy test at screening and agree to use effective contraceptive measures from enrollment until 1 year after MC-1-50 cell infusion.
- Informed Consent: Voluntary written informed consent must be obtained from the subject (if applicable) and their lawful guardians prior to any screening procedures.
Who cannot join
- Prior Cell Therapy: Previous treatment with any CAR-T cell therapy or other genetically modified effector cell products.
- Neurological/CNS Involvement:
- Active central nervous system (CNS) lupus requiring clinical intervention within 60 days of screening (including seizures, delirium, or cerebrovascular events).
- Evidence of significant structural CNS damage on MRI or a history of severe seizures that may lower the threshold for ICANS.
- Severe Renal Impairment and Fibrosis:
- Receiving renal replacement therapy (dialysis) within 3 months prior to infusion.
Show all 27Show fewer
- Irreversible Renal Damage: Documented high chronicity on baseline biopsy (e.g., Chronicity Index >6/12) or extensive renal fibrosis, as these patients are unlikely to achieve functional recovery despite immunological remission.
- Significant nephropathy likely requiring high-dose glucocorticoids (≥1mg/kg/day prednisone or equivalent) or intensified DMARDs within 3 months of infusion.
- Cardiac Conditions:
- Serious congenital heart disease; acute myocardial infarction within 6 months of screening; severe arrhythmias (e.g., multifocal premature ventricular tachycardia); large pericardial effusion; severe myocarditis; or hypotension requiring pressor agents at screening.
- Pulmonary Pathology:
- History of severe lung disease, including significant bronchiectasis, emphysema, or advanced interstitial lung disease (ILD) at baseline.
- Resting oxygen saturation (SpO2 <92%).
- Concomitant Therapy: Requirement for long-term glucocorticoids or immunosuppressive therapy for conditions other than SLE.
- Infections: Active infections requiring systemic treatment or uncontrollable infections (bacterial, fungal, or viral) within 1 week before screening.
- Transplantation/GVHD: Solid organ or hematopoietic stem cell transplantation within 3 months before screening; or presence of Grade 2 or higher acute graft-versus-host disease (GVHD) within 2 weeks of screening.
- Viral and Serological Markers:
- Positive HBsAg or HBcAb with detectable HBV-DNA.
- Positive HCV antibody with detectable HCV-RNA.
- Positive HIV antibody, syphilis test, or detectable CMV-DNA.
- Other Clinical Conditions:
- Macrophage activation syndrome (MAS) within 1 month before screening.
- Vaccination with a live vaccine within 4 weeks before screening.
- Malignancies or other severe systemic diseases.
- Pregnancy: Positive blood pregnancy test at screening.
- Trial Participation: Enrollment in another clinical trial within 3 months prior to this study.
- Investigator Discretion: Any other condition that, in the opinion of the investigator, makes the subject unsuitable for the study or puts them at undue risk.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
About this study
Official title: A Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor T Cell Injection Targeting CD19 Gene in the Treatment of Refractory Systemic Lupus Erythematosus
This is an investigator-initiated trial aimed at assessing the safety of anti-CD19 CAR-T cells in the treatment of refractory systemic lupus erythematosus.
Read the detailed description
Systemic lupus erythematosus (SLE) is a serious autoimmune disease that can lead to extensive damage in multiple organs and systems, ultimately resulting in disability and even death. Children with SLE are particularly at risk of organ damage, especially to the kidneys, and tend to have a more severe and protracted course of the disease compared to adults.
Currently, the primary treatment for SLE relies on glucocorticoids and immunosuppressants to alleviate symptoms. However, due to the absence of a curative treatment, patients often require lifelong medication. In recent years, biological agents such as belimumab and rituximab have been introduced for the treatment of SLE, but these agents cannot completely eliminate autoimmune B cells in the bone marrow, leading to unsatisfactory overall outcomes. Furthermore, stopping the drugs can lead to relapse, and there is still no cure for SLE, leaving patients facing the challenges of lifelong medication and an incurable disease.
Since 2019, CAR-T cell therapy has been successfully applied to autoimmune diseases. Clinical studies have demonstrated that targeted CD19 CAR-T cells hold significant therapeutic potential for SLE. These cells effectively slow down the pathological progression of SLE and can also effectively treat severe cases. Furthermore, targeted CD19 CAR-T cells are also expected to restore the immune system in SLE patients, potentially allowing them to discontinue lifelong medication and avoid serious long-term side effects of drugs like hormones and immunosuppressants. The purpose of this study is to assess the safety and efficacy of the anti-CD19 CAR-T cells in the treatment of refractory SLE.
- Conditions
- Systemic Lupus Erythematosus, CAR-T Cell Therapy
- Being tested
- anti-CD19-CAR-T cells
- Keywords
- Systemic Lupus Erythematosus, CAR-T
- 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.
anti-CD19-CAR-T cellsBiological
The study will primarily evaluate the Target Dose of 1×10^5 CAR+ cells/kg. The majority of subjects will be enrolled at this level to characterize efficacy and safety.
Two exploratory dose levels-Low Dose (0.3×10^5CAR+ cells/kg) and High Dose (3×10^5 CAR+ cells/kg)-are reserved for dose modification based on safety signals or preliminary efficacy data.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T treatment group | Experimental | This is an open-label, single-arm, multicenter, investigator-initiated study. The study will primarily evaluate the Target Dose of 1×10^5 CAR+ cells/kg. The majority of subjects will be enrolled at this level to characterize efficacy and safety. Two exploratory dose levels-Low Dose (0.3×10^5 CAR+ cells/kg) and High Dose (3×10^5 CAR+ cells/kg)-are reserved for dose modification based on safety signals or preliminary efficacy data. Receives: Biological: anti-CD19-CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of CAR-T cells in refractory Systemic Lupus Erythematosus
Incidence, type, and severity of adverse events. The grading of CRS and neurotoxicity follow the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells, published by ASTCT in 2019. Other AEs are graded using the NCI CTCAE 5.0.
Measured: 3 Months
Secondary outcomes (6)
The efficacy of CAR-T cells in refractory Systemic Lupus Erythematosus
Proportion of participants achieving an SRI-4 response at 3 months post-infusion, defined by: a ≥4-point reduction in SLEDAI-2K score; no worsening in Physician's Global Assessment (increase <0.3); and no new major organ involvement as assessed by BILAG.
Measured: 3 months
LLDAS response rate.
LLDAS response rate, defined as the percentage of subjects who meet the following conditions simultaneously after infusion: ①SLEDAI-2K score ≤4, with no activity in major organ systems (including kidney, central nervous system, heart and lungs), no vasculitis and no fever; ② no new lupus disease activity compared with the previous assessment; ③PGA score ≤1; ④serological activity permitted; ⑤ prednisolone dose ≤7.5mg daily and well-tolerated standard maintenance doses of immunosuppressive drugs or biological agents permitted.
Measured: 12 months
DORIS response rate.
DORIS response rate, defined as the percentage of subjects who meet the following conditions simultaneously after infusion: ① clinical SLEDAI-2K score =0; ② PGA score <0.5; ③ serological activity permitted; ④low-dose glucocorticoid (i.e. prednisolone ≤5mg daily) and well-tolerated standard maintenance doses of antimalarials, immunosuppressive drugs or biological agents permitted.
Measured: 12 months
Evaluate the Pharmacokinetics parameters.
PK parameters: The highest concentration (Cmax) of CD19-targeted CAR-T cells expanded in peripheral blood after infusion, the time to reach the highest concentration (Tmax).
Measured: 3 months
Evaluate the Pharmacodynamics parameters.
PD parameters: The degree of B cell depletion at various time points, the concentration levels of CAR-T-related serum cytokines.
Measured: 3 months
Changes in serological biomarkers related with SLE
Changes in serological biomarkers, including anti-dsDNA antibodies and complement C3/C4 levels, which used for evaluating the SLEDAI score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start10 Feb 2024
- Primary completion4 Apr 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 The Children's Hospital of Zhejiang University School of MedicineThe 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
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Precision Biotech Co., Ltd
- Responsible party
- Principal investigator, Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine
- Investigators
- Jianhua Mao, MD, Principal investigator, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222853
- Sponsor's protocol ID
- STEAM
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mackensen A, Muller F, Mougiakakos D, Boltz S, Wilhelm A, Aigner M, Volkl S, Simon D, Kleyer A, Munoz L, Kretschmann S, Kharboutli S, Gary R, Reimann H, Rosler W, Uderhardt S, Bang H, Herrmann M, Ekici AB, Buettner C, Habenicht KM, Winkler TH, Kronke G, Schett G. Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus. Nat Med. 2022 Oct;28(10):2124-2132. doi: 10.1038/s41591-022-02017-5. Epub 2022 Sep 15.
PubMed 36109639Anders HJ, Saxena R, Zhao MH, Parodis I, Salmon JE, Mohan C. Lupus nephritis. Nat Rev Dis Primers. 2020 Jan 23;6(1):7. doi: 10.1038/s41572-019-0141-9.
PubMed 31974366Kansal R, Richardson N, Neeli I, Khawaja S, Chamberlain D, Ghani M, Ghani QU, Balazs L, Beranova-Giorgianni S, Giorgianni F, Kochenderfer JN, Marion T, Albritton LM, Radic M. Sustained B cell depletion by CD19-targeted CAR T cells is a highly effective treatment for murine lupus. Sci Transl Med. 2019 Mar 6;11(482):eaav1648. doi: 10.1126/scitranslmed.aav1648.
PubMed 30842314Jin X, Xu Q, Pu C, Zhu K, Lu C, Jiang Y, Xiao L, Han Y, Lu L. Therapeutic efficacy of anti-CD19 CAR-T cells in a mouse model of systemic lupus erythematosus. Cell Mol Immunol. 2021 Aug;18(8):1896-1903. doi: 10.1038/s41423-020-0472-1. Epub 2020 May 29.
PubMed 32472023Mougiakakos D, Kronke G, Volkl S, Kretschmann S, Aigner M, Kharboutli S, Boltz S, Manger B, Mackensen A, Schett G. CD19-Targeted CAR T Cells in Refractory Systemic Lupus Erythematosus. N Engl J Med. 2021 Aug 5;385(6):567-569. doi: 10.1056/NEJMc2107725. No abstract available.
PubMed 34347960Lee DW, Santomasso BD, Locke FL, Ghobadi A, Turtle CJ, Brudno JN, Maus MV, Park JH, Mead E, Pavletic S, Go WY, Eldjerou L, Gardner RA, Frey N, Curran KJ, Peggs K, Pasquini M, DiPersio JF, van den Brink MRM, Komanduri KV, Grupp SA, Neelapu SS. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood Marrow Transplant. 2019 Apr;25(4):625-638. doi: 10.1016/j.bbmt.2018.12.758. Epub 2018 Dec 25.
PubMed 30592986Neelapu SS, Tummala S, Kebriaei P, Wierda W, Gutierrez C, Locke FL, Komanduri KV, Lin Y, Jain N, Daver N, Westin J, Gulbis AM, Loghin ME, de Groot JF, Adkins S, Davis SE, Rezvani K, Hwu P, Shpall EJ. Chimeric antigen receptor T-cell therapy - assessment and management of toxicities. Nat Rev Clin Oncol. 2018 Jan;15(1):47-62. doi: 10.1038/nrclinonc.2017.148. Epub 2017 Sep 19.
PubMed 28925994
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor T Cell Injection Targeting CD19 Gene in the Treatment of Refractory Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06222853
- Acronym / sponsor ID
- STEAM
- Conditions
- Systemic Lupus Erythematosus, CAR-T Cell Therapy
- Keywords
- Systemic Lupus Erythematosus, CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Collaborators
- Chongqing Precision Biotech Co., Ltd
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 25 Jan 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.
This is an investigator-initiated trial aimed at assessing the safety of anti-CD19 CAR-T cells in the treatment of refractory systemic lupus erythematosus.
Detailed description
Systemic lupus erythematosus (SLE) is a serious autoimmune disease that can lead to extensive damage in multiple organs and systems, ultimately resulting in disability and even death. Children with SLE are particularly at risk of organ damage, especially to the kidneys, and tend to have a more severe and protracted course of the disease compared to adults.
Currently, the primary treatment for SLE relies on glucocorticoids and immunosuppressants to alleviate symptoms. However, due to the absence of a curative treatment, patients often require lifelong medication. In recent years, biological agents such as belimumab and rituximab have been introduced for the treatment of SLE, but these agents cannot completely eliminate autoimmune B cells in the bone marrow, leading to unsatisfactory overall outcomes. Furthermore, stopping the drugs can lead to relapse, and there is still no cure for SLE, leaving patients facing the challenges of lifelong medication and an incurable disease.
Since 2019, CAR-T cell therapy has been successfully applied to autoimmune diseases. Clinical studies have demonstrated that targeted CD19 CAR-T cells hold significant therapeutic potential for SLE. These cells effectively slow down the pathological progression of SLE and can also effectively treat severe cases. Furthermore, targeted CD19 CAR-T cells are also expected to restore the immune system in SLE patients, potentially allowing them to discontinue lifelong medication and avoid serious long-term side effects of drugs like hormones and immunosuppressants. The purpose of this study is to assess the safety and efficacy of the anti-CD19 CAR-T cells in the treatment of refractory SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T treatment group | Experimental | Biological: anti-CD19-CAR-T cellsThis is an open-label, single-arm, multicenter, investigator-initiated study. The study will primarily evaluate the Target Dose of 1×10^5 CAR+ cells/kg. The majority of subjects will be enrolled at this level to characterize efficacy and safety. Two exploratory dose levels-Low Dose (0.3×10^5 CAR+ cells/kg) and High Dose (3×10^5 CAR+ cells/kg)-are reserved for dose modification based on safety signals or preliminary efficacy data. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Age: ≥5 years old.
- Refractory SLE Diagnosis:
- Note: Patients may also be eligible if they are documented as intolerant to these conventional treatments.
- Disease Severity Validation: To ensure a "refractory" status, patients must satisfy at least one of the following:
- Organ Function:
Key exclusion criteria (27 listed)
- Prior Cell Therapy: Previous treatment with any CAR-T cell therapy or other genetically modified effector cell products.
- Neurological/CNS Involvement:
- Severe Renal Impairment and Fibrosis:
- Cardiac Conditions:
- Serious congenital heart disease; acute myocardial infarction within 6 months of screening; severe arrhythmias (e.g., multifocal premature ventricular tachycardia); large pericardial effusion; severe myocarditis; or hypotension requiring pressor agents at screening.
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-CAR-T cellsThe study will primarily evaluate the Target Dose of 1×10^5 CAR+ cells/kg. The majority of subjects will be enrolled at this level to characterize efficacy and safety. Two exploratory dose levels-Low Dose (0.3×10^5CAR+ cells/kg) and High Dose (3×10^5 CAR+ cells/kg)-are reserved for dose modification based on safety signals or preliminary efficacy data. | Biological | CAR-T treatment group |
Primary outcome
The safety of CAR-T cells in refractory Systemic Lupus Erythematosus
Time frame: 3 Months
Incidence, type, and severity of adverse events. The grading of CRS and neurotoxicity follow the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells, published by ASTCT in 2019. Other AEs are graded using the NCI CTCAE 5.0.
6 secondary outcomes
The efficacy of CAR-T cells in refractory Systemic Lupus Erythematosus
Time frame: 3 months
LLDAS response rate.
Time frame: 12 months
DORIS response rate.
Time frame: 12 months
Evaluate the Pharmacokinetics parameters.
Time frame: 3 months
Evaluate the Pharmacodynamics parameters.
Time frame: 3 months
Changes in serological biomarkers related with SLE
Time frame: 12 months
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 4 Feb 2026.
- Results publication: PubMed 36109639Mackensen A, Muller F, Mougiakakos D, Boltz S, Wilhelm A, Aigner M, Volkl S, Simon D, Kleyer A, Munoz L, Kretschmann S, Kharboutli S, Gary R, Reimann H, Rosler W, Uderhardt S, Bang H, Herrmann M, Ekici AB, Buettner C, Habenicht KM, Winkler TH, Kronke G, Schett G. Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus. Nat Med. 2022 Oct;28(10):2124-2132. doi: 10.1038/s41591-022-02017-5. Epub 2022 Sep 15.
- Results publication: PubMed 31974366Anders HJ, Saxena R, Zhao MH, Parodis I, Salmon JE, Mohan C. Lupus nephritis. Nat Rev Dis Primers. 2020 Jan 23;6(1):7. doi: 10.1038/s41572-019-0141-9.
- Results publication: PubMed 30842314Kansal R, Richardson N, Neeli I, Khawaja S, Chamberlain D, Ghani M, Ghani QU, Balazs L, Beranova-Giorgianni S, Giorgianni F, Kochenderfer JN, Marion T, Albritton LM, Radic M. Sustained B cell depletion by CD19-targeted CAR T cells is a highly effective treatment for murine lupus. Sci Transl Med. 2019 Mar 6;11(482):eaav1648. doi: 10.1126/scitranslmed.aav1648.
- Results publication: PubMed 32472023Jin X, Xu Q, Pu C, Zhu K, Lu C, Jiang Y, Xiao L, Han Y, Lu L. Therapeutic efficacy of anti-CD19 CAR-T cells in a mouse model of systemic lupus erythematosus. Cell Mol Immunol. 2021 Aug;18(8):1896-1903. doi: 10.1038/s41423-020-0472-1. Epub 2020 May 29.
- Results publication: PubMed 34347960Mougiakakos D, Kronke G, Volkl S, Kretschmann S, Aigner M, Kharboutli S, Boltz S, Manger B, Mackensen A, Schett G. CD19-Targeted CAR T Cells in Refractory Systemic Lupus Erythematosus. N Engl J Med. 2021 Aug 5;385(6):567-569. doi: 10.1056/NEJMc2107725. No abstract available.
- Results publication: PubMed 30592986Lee DW, Santomasso BD, Locke FL, Ghobadi A, Turtle CJ, Brudno JN, Maus MV, Park JH, Mead E, Pavletic S, Go WY, Eldjerou L, Gardner RA, Frey N, Curran KJ, Peggs K, Pasquini M, DiPersio JF, van den Brink MRM, Komanduri KV, Grupp SA, Neelapu SS. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood Marrow Transplant. 2019 Apr;25(4):625-638. doi: 10.1016/j.bbmt.2018.12.758. Epub 2018 Dec 25.
- Results publication: PubMed 28925994Neelapu SS, Tummala S, Kebriaei P, Wierda W, Gutierrez C, Locke FL, Komanduri KV, Lin Y, Jain N, Daver N, Westin J, Gulbis AM, Loghin ME, de Groot JF, Adkins S, Davis SE, Rezvani K, Hwu P, Shpall EJ. Chimeric antigen receptor T-cell therapy - assessment and management of toxicities. Nat Rev Clin Oncol. 2018 Jan;15(1):47-62. doi: 10.1038/nrclinonc.2017.148. Epub 2017 Sep 19.
- 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. This study is not recruiting at the moment.
Jianhua Mao, MD principal investigator
The Children's Hospital of Zhejiang University School of Medicine
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 anti-CD19-CAR-T cells in people with Systemic Lupus Erythematosus and CAR-T Cell Therapy, run by The Children's Hospital of Zhejiang University School of Medicine 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 17 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 4 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of CAR-T cells in refractory Systemic Lupus Erythematosus (time frame: 3 Months). 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 NCT06222853, which also lists 7 linked publications.
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 4 Feb 2026.