AzTrials
AzTrials

Systemic Lupus ErythematosusPhase 1NCT06852573

Clinical Study of ZM001 Injection in the Treatment of Refractory Systemic Lupus Erythematosus

A Phase 1 study testing ZM001 Injection in people with Systemic Lupus Erythematosus, run by Beijing Immunochina Medical Science & Technology Co., Ltd..

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

This is an open, single-arm, phase I clinical study of ZM001 in patients with refractory systemic lupus erythematosus Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
ZM001 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
No sites listed yet
Study dates
20 Feb 2025to 20 Aug 2027
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with a diagnosis of systemic lupus erythematosus according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria;
  • This trial enrolled patients with refractory SLE and required the following prior treatment history for refractory patients:
  • Adequate standard therapeutic doses of glucocorticoids, immunosuppressants, and at least one biologic therapy combination regimen for at least 2 months prior to screening are required, and the dose is stable for >2 weeks and the disease remains moderately to severely active.
  • Immunosuppressants: at least one or more of cyclophosphamide, mycophenolic acids, azathioprine, and calcineurin phosphatase inhibitors have been used;
  • Biologics: at least one or more of belimumab, tetracycline, rituximab;
  • Oral glucocorticoids must meet the following requirements:
Show all 26Show fewer
  • Prednisone (or equivalent) ≥ 7.5 mg/day and ≤ 60 mg/day;
  • There is no minimum daily dose requirement for glucocorticoids when used in combination with immunosuppressive and/or biological agents.
  • Compliance at screening: positive anti-nuclear antibodies (ANAs) or positive anti-dsDNA antibodies or positive anti-Smith antibodies;
  • SLEDAI-2000 score ≥7 at screening or combination of vital organs, such as severe immune thrombocytopenia (platelets <30*×10^9/L or <50*×10^9/L with bleeding tendency);
  • Age 18-70 (including boundary values), male and female;
  • Survival is expected to be more than 3 months;
  • Women of childbearing potential who had a negative blood pregnancy test prior to the start of the trial and who agreed to use effective contraception for the duration of the trial up to the last follow-up visit; male subjects whose partners were of childbearing potential agreed to use effective contraception for the duration of the trial up to the last follow-up visit;
  • Blood cell analysis within 3 days prior to single collection:
  • Hemoglobin (Hb) ≥ 80 g/L;
  • Neutrophils (Absolute neutrophil count (ANC)) ≥ 1.5 x 109/L;
  • Platelet count (PLT) ≥ 20 x 109/L;
  • Absolute lymphocyte count ≥ 0.6 x 109/L and percentage of lymphocytes ≥ 10%;
  • Liver, kidney, heart, lung function, and coagulation meet the following requirements:
  • Creatinine clearance ≥ 40 ml/min or serum creatinine ≤ 1.5 x upper limit of normal (ULN);
  • ALT, AST ≤ 2.5 x ULN and total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's syndrome, ALT, AST ≤ 5 x ULN and total bilirubin ≤ 3 x ULN);
  • International ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;
  • Left ventricular ejection fraction ≥ 50%;
  • Finger pulse oximetry saturation >92% in non-oxygenated state;
  • Vascular access is adequate for cell collection, and lines are available for patients with existing central venous catheters;
  • The person himself/herself or his/her legal guardian agrees to participate in this trial and signs the informed consent form.

Who cannot join

  • Pre-existing or clinically significant CNS disorders not due to lupus at the time of screening, such as convulsive seizures, epilepsy, epileptic seizures, cerebrovascular disease (ischemia/hemorrhage), cerebral edema, reversible posterior leukoencephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, encephalitis, CNS vasculitis, or psychiatric disorders; epilepsy due to lupus, stable without seizures for a period of 1 year prior to the screening period Stable seizure-free for 1 year may also be screened.
  • Treatment with hemodialysis, or high-dose corticosteroids (prednisone ≥1.5 mg/kg/d or equivalent glucocorticoid therapy for ≥14 days) was required within 2 months prior to screening.
  • Presence of still uncontrolled lupus crisis within 2 months prior to screening that is assessed by the investigator to be unsuitable for participation in this study;
  • Massive plasmapheresis (e.g., pleural effusion, abdominal effusion) with symptoms of compression that cannot be controlled with treatment;
  • Active autoimmune disease other than SLE (e.g., Crohn's disease, rheumatoid arthritis) requiring systemic immunosuppressive therapy within 2 years prior to the start of screening;
  • Patients who have previously received or are awaiting hematopoietic stem cell/bone marrow transplantation or organ transplantation;
Show all 20Show fewer
  • Those who have received prior genetically modified cell therapy, such as TCR-T therapy, CAR-T therapy, etc;
  • Use of any other clinical investigational drug for the treatment of SLE within 4 weeks prior to screening. However, treatment ineffectiveness or disease progression that has passed at least 3 half-lives prior to screening will allow enrollment;
  • History of grade ≥2 bleeding within 30 days prior to screening or need for long-term continuous treatment with anticoagulants (e.g., warfarin, low molecular heparin, or factor Xa inhibitors);
  • Plasma exchange, plasma separation, hemodialysis, intravenous immunoglobulin (IVIG) within 14 days prior to cell collection;
  • Those who used drugs to stimulate bone marrow hematopoietic cell production within 5 days prior to cell collection;
  • Live or live attenuated vaccine within 6 weeks prior to screening;
  • Active hepatitis B or hepatitis C virus, defined as subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and whose peripheral blood HBV-DNA test is above the lower limit of detection (HBsAg-positive but with a peripheral blood HBV-DNA test below the lower limit of detection according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B, 2022 Edition, at least 4 weeks of antiviral therapy prior to the first administration of the investigational drug, and continued antiviral therapy for 6 to 6 months during the study, with monitoring of HBV DNA and ALT levels required may be every 1~month. Antiviral therapy for at least 4 weeks prior to the first dose of study drug and continued for 6-12 months during the course of the study, with monitoring of HBV DNA, HBsAg, and ALT levels at 1-3 month intervals); Hepatitis C Virus (HCV) antibody-positive subjects with a peripheral blood HCV-RNA test higher than the lower limit of detection; HIV antibody-positive subjects; and syphilis antibody-positive subjects;
  • Active EBV and cytomegalovirus, defined as subjects with IgM antibody-positive or IgM antibody-negative EBV serum but higher-than-normal EBV-DNA; and cytomegalovirus (CMV) serum IgM antibody-positive or IgM antibody-negative cytomegalovirus but higher-than-normal CMV-DNA;
  • Presence of chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), and clinically significant pulmonary function test abnormalities;
  • Medically uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg) or a history of any of the following cardiovascular diseases within 6 months prior to the start of screening: long QTc syndrome or QTc interval >480 ms; complete left bundle branch block, second/third degree atrioventricular block; severe uncontrolled cardiac arrhythmias that require medication; history of chronic congestive heart failure with NYHA class ≥3 (refer to Appendix 2) cardiac ejection fraction less than 50% within 6 months prior to screening; CTCAE ≥3; CTCAE ≥3; and CTCAE ≥3. controlled arrhythmia; history of chronic congestive heart failure with NYHA class ≥3 (refer to Attachment 2) cardiac ejection fraction less than 50% within 6 months prior to screening; CTCAE class ≥3 cardiac valvular disease; myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, history of severe pericardial disease, or other clinically significant cardiac disease within 6 months prior to screening;
  • History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to initiation of screening;
  • Other untreated malignant tumors within the previous 5 years or concurrently, except cervical cancer in situ, basal cell carcinoma of the skin, and ductal carcinoma in situ of the breast;
  • Infections (fungal, bacterial, viral, or other) that require intravenous antimicrobial control or are uncontrollable, for simple urinary tract infections, and for bacterial pharyngitis, may be enrolled if the investigator evaluates that they can be controlled by curative treatment;
  • The presence of any factors affecting compliance with the protocol, or the unwillingness or inability of the subject to comply with the procedures required in the study protocol, as judged by the investigator.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Fei Wu contact

8615801390058

wufei@imunopharm.com

Mengtao Li, PhD contact

861065296114

Mengtao.li@cstar.org.cn

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety and Efficacy of ZM001 Injection in the Treatment of Refractory Systemic Lupus Erythematosus

This is an open, single-arm, phase I clinical study of ZM001 in patients with refractory systemic lupus erythematosus

Read the detailed description

This study is planned to enroll 12-30 patients with refractory SLE in a dose-escalation "3+3" design with 4 dose groups, 2.5×10^7 CAR-T cells, 5×10^7 CAR-T cells, 1×10^8 CAR-T cells and 2×10^8 CAR-T cells. Each dose group is planned to enroll 3-6 subjects to evaluate its safety. -T cells. 3-6 subjects are planned to be enrolled in each dose group to assess safety, and if subjects in a dose group have a horizontal dose-limiting toxicity (DLT) incidence of≤ 1/6 within 28 days of infusing back, cell infusing back into the next dose group of subjects may be initiated. One or two dose groups will be selected to enroll additional subjects in the study for the extension phase based on the opinion of the Drug Safety Monitoring Board, and 3-6 additional subjects are proposed to be enrolled in each selected dose group for further evaluation of safety and efficacy.

This study will be divided into a screening period, a cell collection period, a chemotherapy pretreatment period, a return infusion and a follow-up period, and within 28 days of return infusion the investigator will assess whether a DLT (Dose limited toxicity) event has occurred to confirm the safety of this dose group.

Being tested
ZM001 Injection
Keywords
ZM001 CD19 CAR-T, refractory systemic lupus erythematosus
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.

  • ZM001 InjectionBiological

    ZM001 injection, 2.5× 10^7 CAR-T cells, 5× 10^7 CAR-T cells, 1× 10^8 CAR-T cells and 2× 10^8 CAR-T cells, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 30 mg/m^2 (D-5~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 300 mg/ m^2 (D-5~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 300 mg/ m^2 (D-5~D-3), determined by tumor burden at baseline.

Study groups in NCT06852573
Study groupRoleWhat they receive
ZM001 InjectionExperimentalAfter preconditioning with chemotherapy, ZM001 Injection will be evaluated
Receives: Biological: ZM001 Injection

What is being measured

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

  1. Incidence of Treatment Related adverse events (AEs)

    Incidence of adverse events associated with ZM001 reinfusion within 28 days of ZM001 reinfusion, type, frequency, and severity of abnormal clinically significant vital signs, electrocardiograms, and laboratory tests examined, including dose-limiting toxicity

    Measured: Up to 28 days after CAR-T cell infusion

Secondary outcomes (22)

  1. Lupus Low Disease Activity State (LLDAS)

    Proportion of subjects achieving Lupus Low Disease Activity State (LLDAS) at 12 weeks/24 weeks after ZM001 infusion

    Measured: Up to 24 week after CAR-T cell infusion

  2. disease remission (DORIS)

    Proportion of subjects achieving disease remission (DORIS) at 12 weeks/24 weeks after ZM001 infusion

    Measured: Up to 24 week after CAR-T cell infusion

  3. SLEDAI-2K score

    SLEDAI-2K score change from baseline values at 12 weeks/24 weeks after ZM001 infusion

    Measured: Up to 24 week after CAR-T cell infusion

  4. British Isles Lupus Assessment Group Index (BILAG-2004)

    British Isles Lupus Assessment Group Index (BILAG-2004) change from baseline values at 12 weeks/24 weeks after ZM001 infusion

    Measured: Up to 24 week after CAR-T cell infusion

  5. Clinician's general judgment (PGA)

    Clinician's general judgment (PGA) change from baseline values at 12 weeks/24 weeks after ZM001 infusion

    Measured: Up to 24 week after CAR-T cell infusion

  6. Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS)

    Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) change from baseline values at 12 weeks/24 weeks after ZM001 infusion

    Measured: Up to 24 week after CAR-T cell infusion

  7. SLE Response Index 4 (SRI-4)

    Proportion of subjects achieving SLE Response Index 4 (SRI-4) at 12 weeks/24 weeks after ZM001 infusion

    Measured: Up to 24 week after CAR-T cell infusion

  8. quality of life (SF-36)

    quality of life (SF-36) change from baseline values at 12, 24, 48, and 72 weeks after ZM001 infusion back

    Measured: Up to 72 week after CAR-T cell infusion

  9. immunoglobulin-IgG

    Changes of immunoglobulin-IgG after ZM001 infusion

    Measured: Up to 96 week after CAR-T cell infusion

  10. immunoglobulin-IgM

    Changes of immunoglobulin-IgM after ZM001 infusion

    Measured: Up to 96 week after CAR-T cell infusion

  11. immunoglobulin-IgA

    Changes of immunoglobulin-IgA after ZM001 infusion

    Measured: Up to 96 week after CAR-T cell infusion

  12. immunoglobulin-IgE

    Changes of immunoglobulin-IgE after ZM001 infusion

    Measured: Up to 96 week after CAR-T cell infusion

  13. anti-ds-DNA antibody

    Changes of anti-ds-DNA antibody after ZM001 infusion

    Measured: Up to 96 week after CAR-T cell infusion

  14. anti-nuclear antibody

    Changes of anti-nuclear antibody after ZM001 infusion

    Measured: Up to 96 week after CAR-T cell infusion

  15. complement C3

    Changes of complement C3 after ZM001 infusion

    Measured: Up to 96 week after CAR-T cell infusion

  16. complement C4

    Changes of complement C4 after ZM001 infusion

    Measured: Up to 96 week after CAR-T cell infusion

  17. Time to peak (Tmax)

    Time to peak (Tmax) in patients' peripheral blood after ZM001 infusion

    Measured: Up to 28 days after CAR-T cell infusion

  18. peak expansion (Cmax)

    peak expansion (Cmax) in patients' peripheral blood after ZM001 infusion

    Measured: Up to 28 days after CAR-T cell infusion

  19. area under the curve (AUC)

    area under the curve (AUC) in patients' peripheral blood after ZM001 infusion

    Measured: Up to 28 days after CAR-T cell infusion

  20. survival time of CAR-T cells

    survival time of CAR-T cells in patients' peripheral blood after ZM001 infusion

    Measured: Up to 28 days after CAR-T cell infusion

  21. CD19+ B cell levels

    Correlation of CD19+ B cell levels in peripheral blood with reduced disease activity after ZM001 infusion

    Measured: Up to 96 week after CAR-T cell infusion

  22. major B cell functional subpopulations

    changes in major B cell functional subpopulations (initial B cells, memory B cells, and category-switching B cells) in peripheral blood with reduced disease activity after ZM001 infusion

    Measured: Up to 96 week after CAR-T cell infusion

Timeline

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

  1. First posted28 Feb 2025
  2. Study start20 Feb 2025 (estimated)
  3. Primary completion20 Feb 2026 (estimated)
  4. Study completion20 Aug 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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06852573
Sponsor's protocol ID
IM19SLE01
Status last verified
Feb 2025
First submitted
18 Feb 2025
Last updated
28 Feb 2025
Results posted
No
Data monitoring committee
No
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 study testing ZM001 Injection in people with Systemic Lupus Erythematosus, run by Beijing Immunochina Medical Science & Technology Co., Ltd..

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 26 inclusion and 20 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 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

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 Fei Wu (8615801390058, wufei@imunopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment Related adverse events (AEs) (time frame: Up to 28 days after CAR-T cell 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 NCT06852573.

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 28 Feb 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