Systemic Lupus Erythematosus (SLE)NCT06902844
Equecabtagene Autoleucel Injection (Eque-cel) for Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
A study testing Equecabtagene Autoleucel Injection in people with Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN), run by Tongji Hospital at 1 site in China.
Trial summary
This is a single-center, open-label, exploratory clinical study to evaluate the efficacy and safety of Equecabtagene Autoleucel Injection (Eque-cel) in patients with Relapsed /refractory systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
- What is being tested?
- Equecabtagene Autoleucel Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2025to 10 Jan 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years old, male or female;
- Subjects with relapsed/refractory SLE:
- Subjects must be diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria, or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria; the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥8, with a British Isles Lupus Assessment Group 2004 (BILAG-2004) activity score of A in ≥1 organ at screening, or a BILAG-2004 activity score of B in ≥2 organs.
- Subjects with lupus nephritis (LN) must be diagnosed with active, biopsy-confirmed lupus nephritis of type III, IV, or V, or type III/IV combined with type V according to the 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria; the SLEDAI-2000(SLEDAI-2K) score ≥8;
- Regular treatment with glucocorticoids and at least two immunosuppressants，immunomodulators, antimalarials, or biologics for at least 3 months, but withpoorly-controlled symptoms or intolerance to treatment.
- Disease-related pathogenic antibody positive: anti-nuclear antibody (ANA) positive and/or anti-dsDNA positive and/or anti-Smith positive.
- After signing the informed consent form, subjects and their partners must be willing to use effective and reliable method of contraception, devices or medicines, within one year post Eque-cel infusion (excluding contraception safety periods).
- Subjects must provide written informed consent before the study begin.
Who cannot join
- Disease involved the nervous system with a BILAG-2004 activity score of Class A.
- History of solid organ transplantation.
- History of autologous or allogeneic stem cell transplantation.
- History of prior cell therapy or treatment of BCMA-targeted drug.
- Known history of primary immunodeficiency (innate or acquired). 6）Concomitant other autoimmune diseases that may interfere with the study evaluation.
- 7) Subjects who have received the following drugs/non-drug treatment:
Show all 24Show fewer
- Subjects who have used therapeutic doses of corticosteroids (defined as >20 mg/day of prednisone or equivalent) within 1 week prior to enrollment. Corticosteroids must be tapered gradually according to clinical circumstances (e.g., duration and dose of treatment, severity of disease progression, and patient condition) before discontinuation，until reaching the allowable dose range specified in the protocol. Physiological replacement therapy, topical use, and inhaled corticosteroids are permitted.
- Subjects who have used immunosuppressants other than corticosteroids within 1 week prior to enrollment.
- Subjects who received biologic therapies or JAK/BTK/TYK inhibitors within 2 months prior to cell infusion, including but not limited to rituximab, belimumab, or baricitinib.
- Subjects who underwent plasmapheresis or double filtration within 1 week prior to enrollment.
- Subjects who received investigational drugs from another interventional clinical trial within 1 month before signing the informed consent form (ICF).
- Subjects who received treatment of the study disease with any unlisted drugs within at least 5 half-lives prior to cell infusion.
- 8)Major operation or surgical treatment caused by any reason that occurred or was planned within 4 weeks before enrollment or within 12 weeks after cell infusion.
- 9)History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.
- 10)Subjects have uncontrolled active fungal, viral, bacterial, or other infections (with persistent infection-related signs/symptoms that have not improvedafter appropriate anti-infective therapy) or infections requiring intravenous anti-infective therapy.
- 11)Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with abnormal peripheral blood hepatitis B virus (HBV) DNA (defined as HBV DNA ≥100 IU/mL or ≥1000 copies/mL or above the normal reference range of the testing center, or positive qualitative HBV DNA); positive for hepatitis C virus (HCV) antibody with detectable peripheral blood HCV RNA (defined as ≥1000 IU/mL); positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA (defined as ≥1000 IU/mL); or positive for Treponema pallidum-specific antibody with positive rapid plasma reagin (RPR) test.
- 12)Blood tests: Absolute neutrophil count < 1×10^9 /L, or Absolute lymphocyte count < 0.3×10 ^ 9 /L, or hemoglobin <60 g/L。 13)Subjects with serious cardiac disease: including but not limited to unstable angina and/or myocardial infarction within 12 months before screening, any congestive heart failure (New York Heart Association[NYHA] classification ≥Grade III), and a history of severe arrhythmias; or left ventricular ejection fraction (LVEF) <45%.
- 14)Subjects with severe asthma or chronic obstructive pulmonary disease (COPD). Mild or moderate asthma or COPD under stable treatment may be considered with approval from the investigator and sponsor; orarterial oxygen saturation <91% at rest.
- 15）Subjects have a significant risk of severe bleeding assessed by investigator.
- 16) Subjects have a severe hepatic insufficiency assessed by investigator. 17) History of severe renal disease; or an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
- 18) History of acute cerebrovascular events, including transient ischemic attack or stroke, within 6 months prior to enrollment.
- 19) Any severe and/or uncontrolled comorbid conditions that, in the investigator's opinion, may interfere with the study evaluation.
- 20) Diagnosis of malignancy within 5 years prior to screening, except for cured cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ of the breast after radical surgery, or papillary thyroid carcinoma.
- 21) Known history of severe allergy to any component of the eque-cel injection. 22）Pregnant or lactating women. 23) Subjects with other conditions adjudicated by the investigator as unsuitable for enrollment.
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
Tongji Hospital
Wuhan, Hubei, 430030
Lingli Dong, MD, 02783665519, tjhdongll@163.com
About this study
Official title: A Study of Equecabtagene Autoleucel Injection (Eque-cel) in the Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
This is a single-center, open-label, exploratory clinical study to evaluate the efficacy and safety of Equecabtagene Autoleucel Injection (Eque-cel) in patients with Relapsed /refractory systemic lupus erythematosus (SLE).
Read the detailed description
SLE is a chronic diffuse connective tissue disease with unexplained etiology that can involve multiple systems. SLE is considered as an incurable disease and traditional SLE treatment aims at long-term remission. Eque-cel is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), which expressed on both mature B lymphocytes and malignant plasma cells. BCMA CAR-T cells offer another potential therapeutic option to eliminate plasma cells in patients with SLE driven by abnormal antibody who still suffer recurrent attacks from conventional treatments. In this study subjects will receive a three-day consecutive lymphodepletion therapy, and 1.0×10^6 total CAR T cells/kg after enrollment. A follow-up phase will include assessments for safety, efficacy evaluation and pharmacokinetics monitoring. The duration of this trial is about 2-3 years.
- Being tested
- Equecabtagene Autoleucel Injection
- Keywords
- CAR T, SLE, LN
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equecabtagene Autoleucel InjectionDrug
dosage form: injection, dosage: 1.0×10^6 CAR-T/kg, frequency: single dose.
| Study group | Role | What they receive |
|---|---|---|
| 1.0 x 10^6 CAR+ T cells | Experimental | Experimental: Equecabtagene Autoleucel Injection （Eque-cel ） Drug:Equecabtagene Autoleucel Injection Receives: Drug: Equecabtagene Autoleucel Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of SRI-4 at 6 months after Eque-cel infusion
SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline:
- ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.
- No worsening of the overall condition (< 0.3 point increase in Physician's Global Assessment [PhGA]) .
- No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores.
Measured: 6 months post Eque-cel infusion.
Secondary outcomes (13)
lupus low disease activity state (LLDAS) rate through 2 years after Eque-cel infusion
Proportions of subjects achieving LLDAS by timepoint;
Measured: up to 2 years from Eque-cel infusion
Definitions of Remission in SLE (DORIS) rate through 2 years after Eque-cel infusion
Proportions of subjects achieving remission according to the DORIS as assessed by SLEDAI-2K Scale，PhGA Scale and concomitant medication usage.
Measured: up to 2 years from Eque-cel infusion
Complete and Partial Renal Response（Lupus Nephritis Patients）through 2 years after Eque-cel infusion
Proportion of Participants Who Achieve Overall Complete and Partial Renal Response (CRR+PRR).
Measured: up to 2 years from Eque-cel infusion
Safety Endpoint -Adverse Events（AEs）
Type and incidence of AEs as Assessed by CTCAE 5.0 (except CRS and ICANS assessed according to the criteria of NCI-CTCAE v5.0).
Measured: up to 2 years from Eque-cel infusion
Pharmacokinetic Endpoint-Cmax
The maximum concentration (Cmax) of CAR VCN in peripheral blood after CAR-T infusion.
Measured: up to 2 years from Eque-cel infusion
Pharmacokinetic Endpoint-Tmax
the time for CAR VCN to reach the maximum concentration (Tmax) after CAR-T infusion.
Measured: up to 2 years from Eque-cel infusion
Pharmacokinetic Endpoint-AUC
Area under the curve of 28, 90 days and the last time point of PK detection (AUC0-28d, AUC0-90d, AUC0-last) for CAR VCN.
Measured: up to 2 years from Eque-cel infusion
Pharmacokinetic Endpoint-Cmax
The maximum concentration (Cmax) of BCMA CAR-T in peripheral blood after CAR-T infusion.
Measured: up to 90 days from Eque-cel infusion
Pharmacokinetic Endpoint-Tmax
the time for BCMA CAR-T to reach the maximum concentration (Tmax) after CAR-T infusion.
Measured: up to 90 days from Eque-cel infusion
Pharmacokinetic Endpoint-AUC
Area under the curve of 28 days, 90 days (AUC0-28d, AUC0-90) for BCMA CAR-T.
Measured: up to 90 days from Eque-cel infusion
Pharmacodynamic Endpoint- pathogenic antibodies
Changes in serum levels of pathogenic antibodies such as ANA, anti-dsDNA, and anti-Smith.
Measured: up to 2 years from Eque-cel infusion
Pharmacodynamic Endpoint- Complement levels
Changes in measures of C3, C4.
Measured: up to 2 years from Eque-cel infusion
Pharmacodynamic Endpoint-sBCMA
The concentration of soluble BCMA in peripheral blood of experimental group at each time point.
Measured: up to 2 years from Eque-cel infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start5 Apr 2025 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion10 Jan 2028 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing IASO Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Lingli Dong, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902844
- Sponsor's protocol ID
- CT103ACI002
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Equecabtagene Autoleucel Injection (Eque-cel) in the Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT06902844
- Acronym / sponsor ID
- CT103ACI002
- Keywords
- CAR T, SLE, LN
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Nanjing IASO Biotechnology Co., Ltd.
- Study start
- 5 Apr 2025 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 10 Jan 2028 (estimated)
- First posted
- 30 Mar 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.
This is a single-center, open-label, exploratory clinical study to evaluate the efficacy and safety of Equecabtagene Autoleucel Injection (Eque-cel) in patients with Relapsed /refractory systemic lupus erythematosus (SLE).
Detailed description
SLE is a chronic diffuse connective tissue disease with unexplained etiology that can involve multiple systems. SLE is considered as an incurable disease and traditional SLE treatment aims at long-term remission. Eque-cel is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), which expressed on both mature B lymphocytes and malignant plasma cells. BCMA CAR-T cells offer another potential therapeutic option to eliminate plasma cells in patients with SLE driven by abnormal antibody who still suffer recurrent attacks from conventional treatments. In this study subjects will receive a three-day consecutive lymphodepletion therapy, and 1.0×10^6 total CAR T cells/kg after enrollment. A follow-up phase will include assessments for safety, efficacy evaluation and pharmacokinetics monitoring. The duration of this trial is about 2-3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1.0 x 10^6 CAR+ T cells | Experimental | Drug: Equecabtagene Autoleucel InjectionExperimental: Equecabtagene Autoleucel Injection （Eque-cel ） Drug:Equecabtagene Autoleucel Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age≥18 years old, male or female;
- Subjects with relapsed/refractory SLE:
- Disease-related pathogenic antibody positive: anti-nuclear antibody (ANA) positive and/or anti-dsDNA positive and/or anti-Smith positive.
- After signing the informed consent form, subjects and their partners must be willing to use effective and reliable method of contraception, devices or medicines, within one year post Eque-cel infusion (excluding contraception safety periods).
- Subjects must provide written informed consent before the study begin.
Key exclusion criteria (24 listed)
- Disease involved the nervous system with a BILAG-2004 activity score of Class A.
- History of solid organ transplantation.
- History of autologous or allogeneic stem cell transplantation.
- History of prior cell therapy or treatment of BCMA-targeted drug.
- Known history of primary immunodeficiency (innate or acquired). 6）Concomitant other autoimmune diseases that may interfere with the study evaluation.
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 |
|---|---|---|
| Equecabtagene Autoleucel Injectiondosage form: injection, dosage: 1.0×10^6 CAR-T/kg, frequency: single dose. | Drug | 1.0 x 10^6 CAR+ T cells |
Primary outcome
Response rate of SRI-4 at 6 months after Eque-cel infusion
Time frame: 6 months post Eque-cel infusion.
SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline: * ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score. * No worsening of the overall condition (< 0.3 point increase in Physician's Global Assessment [PhGA]) . * No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores.
13 secondary outcomes
lupus low disease activity state (LLDAS) rate through 2 years after Eque-cel infusion
Time frame: up to 2 years from Eque-cel infusion
Definitions of Remission in SLE (DORIS) rate through 2 years after Eque-cel infusion
Time frame: up to 2 years from Eque-cel infusion
Complete and Partial Renal Response（Lupus Nephritis Patients）through 2 years after Eque-cel infusion
Time frame: up to 2 years from Eque-cel infusion
Safety Endpoint -Adverse Events（AEs）
Time frame: up to 2 years from Eque-cel infusion
Pharmacokinetic Endpoint-Cmax
Time frame: up to 2 years from Eque-cel infusion
Pharmacokinetic Endpoint-Tmax
Time frame: up to 2 years from Eque-cel infusion
Pharmacokinetic Endpoint-AUC
Time frame: up to 2 years from Eque-cel infusion
Pharmacokinetic Endpoint-Cmax
Time frame: up to 90 days from Eque-cel infusion
Pharmacokinetic Endpoint-Tmax
Time frame: up to 90 days from Eque-cel infusion
Pharmacokinetic Endpoint-AUC
Time frame: up to 90 days from Eque-cel infusion
Pharmacodynamic Endpoint- pathogenic antibodies
Time frame: up to 2 years from Eque-cel infusion
Pharmacodynamic Endpoint- Complement levels
Time frame: up to 2 years from Eque-cel infusion
Pharmacodynamic Endpoint-sBCMA
Time frame: up to 2 years from Eque-cel 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 30 Mar 2025.
- Individual participant dataSharing planned: Yes. upon reasonable request
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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 study testing Equecabtagene Autoleucel Injection in people with Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN), run by Tongji 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 8 inclusion and 24 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 30 Mar 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.
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 Lingli Dong, MD (+862783665519, tjhdongll@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate of SRI-4 at 6 months after Eque-cel infusion (time frame: 6 months post Eque-cel infusion.). 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 30 Mar 2025.