Using Relma-cel to treat moderate to severe systemic lupus erythematosus

A Phase I Dose-escalation Study Evaluate the Safety Tolerability Pharmacokinetics(PK) and Pharmacodynamics(PD) of Relma-cel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus (SLE)

This study is testing a new treatment called Relma-cel to see if it can help adults with moderate to severe lupus who haven't found relief with regular medications.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd. (industry)
• Drugs / interventions: methotrexate, cyclophosphamide, Prednisone
• Locations: 1 site (Shanghai)
• Trial ID: NCT05765006 on ClinicalTrials.gov

What this trial studies

This phase I, open-label, single-arm, multicenter study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of Relma-cel in adults with moderate to severe active systemic lupus erythematosus (SLE) in China. Participants will receive escalating doses of CAR+ T cells to determine the recommended phase 2 dose (RP2D). The study aims to assess how well Relma-cel can manage symptoms and improve the condition of SLE patients who have not responded adequately to standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a confirmed diagnosis of systemic lupus erythematosus who have experienced active disease despite standard treatment.

Not a fit: Patients with mild SLE or those who have not been on a stable standard treatment regimen may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from moderate to severe systemic lupus erythematosus.

How similar studies have performed: While this approach is novel in the context of systemic lupus erythematosus, similar CAR T-cell therapies have shown promise in other autoimmune conditions and cancers.

Eligibility criteria

Inclusion Criteria:

1. Sign an informed consent form (ICF) voluntarily.
2. At the time of signing the ICF, you must be between 18 and 70 years old (inclusive), male or female.
3. A diagnosis of SLE according to the 1997 revised criteria of the American College of Rheumatology (ACR).
4. The history of SLE prior to screening was at least 6 months, and the disease remained active at least 2 months after the use of a stable standard SLE regimen prior to screening.

Standard treatment regimen refers to the steady use of any of the following (alone or in combination) : corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and other immunosuppressants or immunomodulators including azathioprine, Mycophenolate Mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, and cyclosporine.

Oral corticosteroids must meet the following requirements:

1. Prednisone (or equivalent) ≥7.5 mg/ day, and ≤30 mg/ day.
2. There is no minimum daily dose requirement for corticosteroids when used in combination with immunosuppressants.
3. At least 8 weeks of treatment prior to screening, and the dose must be kept stable for \> 2 weeks.

5. Screening is positive for antinuclear antibodies, and/or anti-DS-DNA antibodies, and/or anti-Smith antibodies.

6. SELENA-SLEDAI score ≥8 during the screening period. Score ≥6 for SELENA-SLEDAI clinical symptoms (except for low complement and/or anti-DS-DNA antibodies) if low complement and/or anti-DS-DNA antibody score is present.

Exclusion Criteria:

1. Severe lupus nephritis (defined as proteinuria \> 6 g/24h or serum creatinine \> 2.5 mg/dL or 221 μmol/L), treatment with active nephritis with Prohibited drugs, hemodialysis, or prednisone ≥100 within 8 weeks prior to screening mg/d or equivalent glucocorticoid therapy ≥14 days.
2. Prior to screening, other lupus crises, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe agranulocytosis, severe myocardial damage, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, and severe vasculitis.
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.
4. Combined with other autoimmune diseases, systematic treatment is needed.
5. History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
6. IgA deficiency was present during screening (serum IgA level \< 10 mg/dL)

Where this trial is running

Shanghai

• Relma-cel Medical — Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: yu Hu — Wuhan Union Hospital, China
• Study coordinator: medical JW

Conditions: Systemic Lupus Erythematosus, Relma-cel, Systemic lupus erythematosus, CD19-CART