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Relma-cel for Moderate to Severe Active Systemic Lupus Erythematosus | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

Relma-cel for Moderate to Severe Active Systemic Lupus Erythematosus

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

NCT06297408•Shanghai Ming Ju Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

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

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).

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily signed an informed consent form (ICF).
•2. Applicants must be between 18 and 70 years old (inclusive) at the time of signing the ICF, male or female.
•3. Diagnosed with SLE according to the 2012 SLICC or 2019 EULAR/ACR version of the revised criteria.
•4. 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:
•1. Prednisone (or equivalent) ≥7.5 mg/day and ≤60 mg/day.
•2. 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:
+8 more criteria

Exclusion Criteria

•1. 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.
•2. Suffering from lupus crisis within 1 months before screening, assessed by the researcher as unsuitable for participation in this study.
•3. 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.
•4. Combined with other autoimmune diseases, systemic treatment is required.
•5. History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
•6. 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.
+7 more criteria

Key Dates

Start Date

March 1, 2024

Primary Completion Date

May 1, 2025

Completion Date

May 1, 2026

Last Updated

March 7, 2024

Enrollment

ESTIMATED participants

Conditions

Systemic Lupus Erythematosus

Interventions

Relma-cel

DRUG

Contacts

JW Medical

CONTACT

021-50464201 Relma-celMedical@jwtherapeutics.com

Yue Dong

CONTACT

01069154127 dongyue@pumch.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Relma-cel for Moderate to Severe Active Systemic Lupus Erythematosus

Inclusion Criteria

Exclusion Criteria

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