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Lupus ErythematosisPhase 1NCT06468683

F01 in the Treatment of Moderate-to-severe Refractory Systemic Lupus Erythematosus

A Phase 1 study testing After preconditioning with chemotherapy, F01 will be evaluated. in people with Lupus Erythematosis, run by Shanghai Simnova Biotechnology Co.,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

This is a phase I clinical study to evaluate the safety , pharmacokinetic profile, and preliminary efficacy of F01 in patients with moderate-to-severe refractory systemic lupus erythematosus. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Lupus Erythematosis
What is being tested?
After preconditioning with chemotherapy, F01 will be evaluated.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
15 Jun 2024to 31 Dec 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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following inclusion criteria to be enrolled in the study:
  • Age ≥18 and ≤65 years old, gender unlimited.
  • Subjects with moderate-to-severe refractory SLE must meet all of the following criteria:
  • Diagnosis of SLE at least 24 weeks prior to screening in accordance with the European Federation of Rheumatological Societies (EULAR)/American College of Rheumatology (ACR) 2019 SLE classification criteria at screening;
  • Applicants must meet one of the following criteria at screening: a. positive for antinuclear antibody (ANA); b. Positive anti-dsDNA antibody;c. Positive anti-Smith antibody;
  • SLEDAI-2000 score ≥ 8 at screening
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  • Have received adequate standard doses of glucocorticoids, antimalarials, immunosuppressants/immunomodulators, and at least one biologic agent for at least 2 months prior to screening, with a stable dose \> disease remaining active after 2 weeks of treatment. Oral glucocorticoids must meet the following requirements: 1) Prednisone (or equivalent) ≥ 7.5 mg/day and ≤ 60 mg/day. 2) When used in combination with immunosuppressants and/or biologics, there is no minimum daily dose requirement for glucocorticoids. The blood routine within 7 days of clear drenching conditioning chemotherapy meets the following requirements:
  • Absolute neutrophil value (ANC) ≥ 1.5×109/L;
  • Hemoglobin (Hb) ≥ 80g/L;
  • Platelet count (PLT) ≥ 50×109/L.
  • Adequate hepatic, renal, lung, and cardiac function, defined as:
  • Serum ALT and AST ≤ 2.5 times the upper limit of normal;
  • Total bilirubin ≤ 1.5 times the upper limit of normal, except for patients with Gilbert\'s syndrome, where total bilirubin must be ≤ 3.0 times the upper limit of normal;
  • creatinine clearance (estimated by Cockcroft Gault\'s formula) (Appendix 1) ≥ 50 ml/min;
  • Oxygen saturation of ≥ 92% in non-oxygenated conditions under indoor ventilation; No clinically significant pleural effusion;
  • Left ventricular ejection fraction ≥ 50%; Echocardiography to confirm the absence of pericardial effusion; There were no clinically significant abnormal findings on ECG.
  • Subjects receiving hematopoietic growth factor supportive therapy, including erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage-colony-stimulating factor (GM-CSF) and platelet agonists (TPO), etc., must have a 2-week gap between the last growth factor supportive therapy and the screening period evaluation; Patients receiving blood product transfusions should have at least 1 week between the screening platelet assessment and the last platelet transfusion, and at least 2 weeks between the screening hemoglobin assessment and the last red blood cell transfusion.
  • During the screening period, female subjects of childbearing potential must have a negative serum pregnancy test result (women who have been surgically sterilized or postmenopausal for at least 2 years are considered not of childbearing potential). Female subjects of childbearing potential and male subjects must use a highly effective method of contraception throughout the clinical study period and for 1 year after the last dose of study treatment; At the same time, a commitment should be made not to donate eggs (oocytes, oocytes)/sperm for assisted reproduction within 1 year after the last study treatment.
  • Voluntarily participate in clinical trials and sign informed consent.

Who cannot join

  • Subjects who meet any of the following exclusion criteria will not be admitted to this clinical study:
  • Known allergies, hypersensitivity, intolerance, or contraindications to F01 or any ingredient of drugs that may be used in the study (including fludarabine, cyclophosphamide, tocilizumab), or subjects who have had severe allergic reactions in the past.
  • Severe lupus nephritis (defined as urine protein \>6g/24 hours or serum creatinine \>2.5mg/dL or 221μmol/L) within 3 months prior to screening, or requiring active nephritis with drugs prohibited by the protocol, or requiring hemodialysis or treatment with prednisone ≥100mg/d or equivalent glucocorticoids ≥for 14 days.
  • Previous history or pathological changes of clinically significant central nervous system disease, including but not limited to lupus encephalopathy, seizures, cerebrovascular accident (ischemia/hemorrhage), dementia, cerebellar disease, organic encephalopathy syndrome, encephalitis, central nervous system vasculitis, or psychiatric disease.
  • Combined with severe pulmonary diseases, such as pulmonary hypertension with World Health Organization functional classification ≥ level 3, requiring oxygen therapy with an oxygen storage mask or non-invasive or invasive ventilator to assist breathing at screening;
  • Unstable cardiovascular function:
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  • Myocardial infarction within 6 months prior to screening;
  • Unstable angina within 3 months prior to screening;
  • Uncontrolled, clinically significant cardiac arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes);
  • Mobitz type II. second-degree or third-degree atrioventricular block;
  • New York Cardiac Function Association Class ≥ 3 congestive heart failure;
  • Poorly controlled hypertension (systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg) or concomitant hypertensive crisis or hypertensive encephalopathy;
  • Patients with a history of concomitant malignancy, including tumor-associated polymyositis/dermatomyositis. Patients with non-melanoma skin cancer, carcinoma in situ of the cervix, local prostate cancer, low-stage bladder cancer, ductal carcinoma in situ, or patients who have no evidence of recurrence in the past 2 years and do not need treatment are excluded.
  • Uncontrolled active bacterial, viral, fungal, mycobacterial infection or other infections requiring treatment with intravenous antibiotics, antiviral or antifungal drugs within 14 days prior to drenching conditioning chemotherapy; However, these drugs can be used for prophylactic treatment (including intravenous use).
  • Risk of active tuberculosis at screening, regardless of completion of adequate treatment, including the presence of signs or symptoms of active tuberculosis (such as fever, cough, night sweats, and weight loss) as judged by the investigator at screening; Chest imaging (e.g., chest x-ray, chest CT scan) documented at screening or at any time within 6 months prior to screening showing active tuberculosis; Evidence of latent tuberculosis infection, such as a positive γ-interferon release test, at screening.
  • Active hepatitis B virus (HBV), hepatitis C virus (HCV) infection at screening. Subjects who are HBsAg positive and/or HBcAb positive but HBV-DNA negative, and/or HCVAb positive but HCV-RNA negative are allowed to be enrolled (if the site report includes a range of reference values, the upper limit of normal for HBV-DNA and HCV-RNA tests is based on the test values of each site, and higher than the upper limit of test values is defined as \"positive\"; If the site report only shows \"negative/positive\", the positive is based on the test report result).
  • Known serum HIV virus antibody positivity or history of active HIV infection, as well as syphilis antibody positive.
  • Received the following treatments within the prescribed time frame prior to drenching conditioning chemotherapy:
  • Received autologous/allogeneic hematopoietic stem cell transplantation within 3 months;
  • Received ultraviolet radiation therapy within 6 weeks;
  • Received macromolecule therapy (excluding anti-CD20 monoclonal antibodies) within 4 weeks or 3 half-lives (whichever is longer); Received anti-CD20 monoclonal antibody therapy within 4 weeks;
  • Received small molecule targeted therapy within 2 weeks or 3 half-lives (whichever is longer);
  • Major surgery or live vaccination within 4 weeks;
  • Received a trial treatment within 4 weeks (except in the definitive placebo control group);
  • Pregnant or lactating women.
  • Use of concomitant medications/concomitant treatments expressly prohibited by the protocol during the screening period.
  • Presence of any life-threatening disease, medical condition, or organ system dysfunction that, in the opinion of the investigator, may affect the subject\'s safety or study compliance.

Trial locations and contacts

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

Director Clinical Trial Disclosure Simnova Director Clinical Trial Disclosure Simnova contact

021-68099999

Disclosure@simnovabio.com

China1 site

  • Shanghai jiaotong University School of Medicine,Renji Hospital

    Shanghai, Shanghai Municipality, 200000

    Shuang YE, 15801706421, Yeshuang@renji.com

    Qiong FU, 13585603288, Fuqiong5@163.com

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of F01 in Patients With Moderate-to-severe Refractory Systemic Lupus Erythematosus

This is a phase I clinical study to evaluate the safety , pharmacokinetic profile, and preliminary efficacy of F01 in patients with moderate-to-severe refractory systemic lupus erythematosus.

Read the detailed description

Approximately up to about 50 participants with moderate-to-severe refractory systemic lupus erythematosus are planned to enroll. This study is divided into two stages: dose escalation and dose extension.

Being tested
After preconditioning with chemotherapy, F01 will be evaluated.
Keywords
Moderate-to-severe 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.

  • After preconditioning with chemotherapy, F01 will be evaluated.Biological

    Biological: 0.5-3×10^9 CAR+NK Cells, Treatment follows a lymphodepletion Drug: Fludarabine: 25-30 mg/m^2 (D-5~D-3) Drug: Cyclophosphamide: 250-300 mg/ m^2 (D-5~D-3)

Study groups in NCT06468683
Study groupRoleWhat they receive
Experimental: After preconditioning with chemotherapy, F01 will be evaluated.ExperimentalAssigned Interventions
Receives: Biological: After preconditioning with chemotherapy, F01 will be evaluated.

What is being measured

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

  1. Primary Outcome Measures

    The proportion of subjects with AEs and SAEs

    Measured: 12 weeks

  2. Primary Outcome Measures

    The proportion of subjects with DLT

    Measured: 4 weeks

Secondary outcomes (8)

  1. Secondary Outcome Measures

    Efficacy of F01 cells in moderate-to-severe refractory systemic lupus erythematosus

    Measured: 48 weeks

  2. Secondary Outcome Measures

    Cellular kinetics [ Time Frame: 96 weeks] The maximum concentration (Cmax)

    Measured: 96 weeks

  3. Secondary Outcome Measures

    Cellular kinetics [ Time Frame: 96 weeks] the time to reach the highest concentration (Tmax)

    Measured: 96 weeks

  4. Secondary Outcome Measures

    Cellular kinetics [ Time Frame: 96 weeks] the area under the curve of the drug time (AUC0-last)

    Measured: 96 weeks

  5. Secondary Outcome Measures

    Cellular kinetics [ Time Frame: 96 weeks] the last detectable concentration point (Clast)

    Measured: 96 weeks

  6. Secondary Outcome Measures

    Cellular kinetics [ Time Frame: 96 weeks] the time of the last detectable concentration (Tlast), etc.

    Measured: 96 weeks

  7. Secondary Outcome Measures

    Cellular kinetics [ Time Frame: 96 weeks] dynamic changes in cytokine levels in the subject's peripheral blood at baseline and after dosing; The number of cases, positive rate

    Measured: 96 weeks

  8. Secondary Outcome Measures

    Cellular kinetics [ Time Frame: 96 weeks] duration of anti-CAR and IL-15 antibodies (ADA)

    Measured: 96 weeks

Timeline

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

  1. First posted21 Jun 2024
  2. Study start15 Jun 2024 (estimated)
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Dec 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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06468683
Sponsor's protocol ID
SNC 103-CD19CAR NK-104
Status last verified
May 2024
First submitted
31 May 2024
Last updated
21 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing After preconditioning with chemotherapy, F01 will be evaluated. in people with Lupus Erythematosis, run by Shanghai Simnova Biotechnology Co.,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 19 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: opening soon, as of the sponsor's last update on 21 Jun 2024. 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?

Contact Director Clinical Trial Disclosure Simnova Director Clinical Trial Disclosure Simnova (021-68099999, Disclosure@simnovabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome Measures (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06468683.

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 21 Jun 2024.

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