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Systemic Lupus ErythematosusPhase 1NCT06297408

Relma-cel for Moderate to Severe Active Systemic Lupus Erythematosus

A Phase 1 study testing Relma-cel in people with Systemic Lupus Erythematosus, run by Shanghai Ming Ju Biotechnology Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To assess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China. 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?
Relma-cel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
Mar 2024to May 2026
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Voluntarily signed an informed consent form (ICF).
  • Applicants must be between 18 and 70 years old (inclusive) at the time of signing the ICF, male or female.
  • Diagnosed with SLE according to the 2012 SLICC or 2019 EULAR/ACR version of the revised criteria.
  • Disease remaining active after receiving corticosteroids combined immunosuppressive therapy and/or biological agents, with a stable treatment plan for at least 2 months and a stable dose for at least 2 weeks before screening.
  • Oral corticosteroids must meet the following requirements:
  • Prednisone (or equivalent) ≥7.5 mg/day and ≤60 mg/day.
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  • When used in combination with immunosuppressants, there is no minimum daily dose requirement for corticosteroids.
  • 5. Positive antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody at screening.
  • 6. SELENA-2k score ≥7 points during the screening period. 7. Active organ involvement during screening period. 8. No active infection (e.g., pneumonia, tuberculosis) within 2 weeks prior to screening period.
  • 9. Vascular access is sufficient for leukapheresis. 10. Adequate organ function:
  • Renal function: defined as creatinine clearance (Cockcroft-Gault) ≥40 mL/min calculated without hydration assistance.
  • Bone marrow function: defined as absolute neutrophil count (ANC) ≥1000 /μL, absolute lymphocyte count (ALC) ≥100 /μL, hemoglobin (Hb) ≥60 g/L, platelet count (PLT) ≥20,000 /μL. Blood transfusions and CSF must not be used to meet these requirements during the 7 days prior to eligibility screening.
  • Liver function: defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, total bilirubin < 2.0 mg/dL (total bilirubin < 3.0 mg/dL in subjects with Gilbert syndrome, except for caused by SLE).
  • Coagulation function: defined as international ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN.
  • Lung function: defined as ≤CTCAE grade 1 dyspnea and blood oxygen saturation (SpO2) ≥92% in indoor air (measured by pulse oximeter).
  • Cardiac function: defined as left ventricular ejection fraction (LVEF) ≥40% as assessed by echocardiography (ECHO) or cardiac radionuclide angiography (MUGA) within 8 weeks prior to screening.
  • 11. Fertile women (defined as all women biologically capable of becoming pregnant) must consent to the use of a highly effective contraceptive method for contraception from at least 28 days before the start of lymphodepleting and 2 years after infusion of Relma-cel (including the duration of the dose-interrupted study treatment). Men whose partners are fertile must agree to use an effective barrier method of contraception from the start of lymphodepleting until 2 year after Relma-cel infusion and should not donate semen or sperm throughout the study period.
  • 12. Fertile women must test negative for serum beta human chorionic gonadotropin (β-hCG) at the time of screening and within 48 hours before the first day of lymphodepleting treatment.

Who cannot join

  • Subjects who meet any of the following exclusion criteria should not be included in this study
  • Severe lupus nephritis within 2 months before screening requires hemodialysis, or treatment with prednisone(or equivalent hormone) ≥100 mg/d for more than 14 days.
  • Suffering from lupus crisis within 1 months before screening, assessed by the researcher as unsuitable for participation in this study.
  • Clinically significant central nervous system diseases or pathological changes not caused by lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. Central nervous system manifestations caused by lupus before screening, including but not limited to lupus headache, epileptic seizures, cognitive impairment, impaired intellectual function, visual impairment, etc.
  • Combined with other autoimmune diseases, systemic treatment is required.
  • History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
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  • When screening:
  • 1) Active hepatitis B. However, hepatitis B surface antigen (HBsAg) positive and/or anti-hepatitis B core antibody (HBcAb) positive, and HBV DNA below the lower limit of the central reference value are eligible for inclusion in this study, and investigators need to provide preventive antiviral therapy to participants as appropriate.
  • 2) Hepatitis C or human immunodeficiency virus (HIV) or syphilis infection. 7. A history of any of the following cardiovascular diseases in the 6 months prior to screening: Class III or IV heart failure as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant heart disease.
  • 8. Use any other clinical study drugs within 1 month before screening. However, if the research treatment is ineffective or the disease relapses, and at least 3 half-life period have been passed before screening, enrollment is allowed.
  • 9. Previously received CAR-T cell or other genetically modified T cell therapies.
  • 10. There was a history of ≥grade 2 bleeding within 30 days prior to screening, or long-term treatment with anticoagulants (such as warfarin, low molecular weight heparin, or factor Xa inhibitors).
  • 11. Plasma exchange, plasma separation or hemodialysis were performed within 14 days before leukapheresis.
  • 12. Use any live vaccine against infectious diseases within 1 month prior to screening.
  • 13. Known life-threatening allergic reactions, hypersensitivities, or intolerances to Relma-cel or their excipients, including DMSO.
  • 14. A history or evidence of suicidal thoughts in the 6 months before signing the ICF, or any suicidal behavior in the 12 months prior, or is considered by the investigator there is a significant risk of suicide.
  • 15. Malignant tumor within 2 years before signing the ICF. Exceptions include non-melanoma skin cancer after radical treatment, localized prostate cancer, biopsy-confirmed cervical carcinoma in situ or squamous intraepithelial lesions detected by cervical smear, and completely resected breast carcinoma in situ.
  • 16. Pregnant or lactating women. 17. Other situations in which the investigator determines that the subject has poor compliance or is unwilling or unable to comply with the study protocol.

Trial locations and contacts

No sites are listed yet.

JW Medical contact

021-50464201

Relma-celMedical@jwtherapeutics.com

Yue Dong contact

01069154127

dongyue@pumch.cn

About this study

Official title: Relma-cel for Moderate to Severe Active Systemic Lupus Erythematosus Single Arm Phase I and Phase II Randomized Controlled Open, Multicenter Study

To assess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.

Read the detailed description

For phase I to evaluate the safety and tolerability of Relma-cel in moderate to severe active systemic lupus erythematosus (SLE) and determine the Phase II Recommended Dose (RP2D). For phase II to evaluation of the efficacy of Relma-cel (treatment group) in moderate to severe active SLE using the Low Disease Activity State of Lupus (LLDAS) under Phase II Recommended Dose (RP2D) compared to conventional therapy combined with or without biologics (control group).

Being tested
Relma-cel
Keywords
CD19-CART
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.

  • Relma-celDrug

    Also called if necessary can add other anti-SLE treatment such as corticosteroids, immunosuppressants, biologics

    CD19-targeted Chimeric AntigenReceptor (CAR) T Cells

Study groups in NCT06297408
Study groupRoleWhat they receive
Relma-celExperimentalEvaluate the safety and tolerability of Relma-cel in moderate to severe active systemic lupus erythematosus (SLE) and determine the Phase II Recommended Dose (RP2D)
Receives: Drug: Relma-cel

What is being measured

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

  1. DLT rate

    The incidence of dose-limiting toxicity

    Measured: 6months

  2. determine RP2D

    To determine RP2D(Phase 2 recommended dose)

    Measured: 6months

Secondary outcomes (3)

  1. SELENA-SLEDAI

    0 to 4 is basically no disease activity;5 to 9 is light activity;10 to 14 is moderate activity;≥15 is considered heavy activity.

    Measured: 3 months after CD19 cCAR T cells infusion

  2. BILAG -2004

    The BILAG 2004 index categorizes disease activity into 5 different levels from A-E.Grade A represents very active disease.

    Measured: 3 months after CD19 cCAR T cells infusion

  3. PGA (physician global assessment) score

    The PGA scale ranges from "no disease activity" (0) to the "most severe disease activity" (3).the score is between 0 to 3.

    Measured: 3 months after CD19 cCAR T cells infusion

Timeline

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

  1. First posted7 Mar 2024
  2. Study startMar 2024 (estimated)
  3. Primary completionMay 2025 (estimated)
  4. Study completionMay 2026 (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
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06297408
Sponsor's protocol ID
JWCAR029115
Status last verified
Feb 2024
First submitted
29 Feb 2024
Last updated
7 Mar 2024
Results posted
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 36109639

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Relma-cel in people with Systemic Lupus Erythematosus, run by Shanghai Ming Ju Biotechnology 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 18 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 7 Mar 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact JW Medical (021-50464201, Relma-celMedical@jwtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT rate (time frame: 6months). 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 NCT06297408, which also lists 1 linked publication.

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 7 Mar 2024.

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