CD19-CART(Relma-cel) for Moderate to Severe Active Systemic Lupus Erythematosus

NCT05765006 | Unknown Phase 1

• 1 other identifier: JWCAR029012
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.

Conditions

Systemic Lupus Erythematosus

Keywords

Relma-cel; Systemic lupus erythematosus; CD19-CART

Outcome Measures

Primary Outcomes (2)

• DLT rate

  The incidence of dose-limiting toxicity

  3 months

• determine RP2D

  To determine RP2D(Phase 2 recommended dose)

  3 months

Secondary Outcomes (4)

• SELENA-SLEDAI （Safety of Estrogens in Systemic Lupus Erythematosus National Assessment） score； 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.

  3 months

• BILAG -2004（updated version of british isles lupus assessment group ） level；The BILAG 2004 index categorizes disease activity into 5 different levels from A-E.Grade A represents very active disease.

  3 months

• 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.

  3 months

• Autoantibody detection

  3 months

Study Arms (1)

Relma-cel be administrated in four dose level

EXPERIMENTAL

Biological: Relma-cel

Interventions

Relma-cel BIOLOGICAL

CD19-targeted Chimeric AntigenReceptor (CAR) T Cells; Relma-cel be administrated at four dose level:25×106 CAR+ T cells、50×106 CAR+ T cells、100×106 CAR+ T cells/150×106 CAR+ T cells

Relma-cel be administrated in four dose level

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign an informed consent form (ICF) voluntarily.
• At the time of signing the ICF, you must be between 18 and 70 years old (inclusive), male or female.
• A diagnosis of SLE according to the 1997 revised criteria of the American College of Rheumatology (ACR).
• 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:
• Prednisone (or equivalent) ≥7.5 mg/ day, and ≤30 mg/ day.
• There is no minimum daily dose requirement for corticosteroids when used in combination with immunosuppressants.
• At least 8 weeks of treatment prior to screening, and the dose must be kept stable for \> 2 weeks.
• \. Screening is positive for antinuclear antibodies, and/or anti-DS-DNA antibodies, and/or anti-Smith antibodies.
• \. 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.

You may not qualify if:

• 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.
• 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.
• 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.
• Combined with other autoimmune diseases, systematic treatment is needed.
• History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
• IgA deficiency was present during screening (serum IgA level \< 10 mg/dL)

Sponsors & Collaborators

• Shanghai Ming Ju Biotechnology Co., Ltd.: lead

Study Sites (1)

Relma-cel Medical

Shanghai, China

RECRUITING

Related Publications (2)

• Kaufman JL, Deak ST, Erdman W. Radionuclide scans to define patterns of occult myonecrosis. N J Med. 1986 Feb;83(2):101-3. No abstract available.

  PMID: 3005930 RESULT

• Shu J, Xie W, Mei C, Ren A, Ke S, Ma M, Zhou Z, Hu Y, Mei H. Safety and clinical efficacy of Relmacabtagene autoleucel (relma-cel) for systemic lupus erythematosus: a phase 1 open-label clinical trial. EClinicalMedicine. 2025 Apr 30;83:103229. doi: 10.1016/j.eclinm.2025.103229. eCollection 2025 May.

  PMID: 40386685 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

relmacabtagene autoleucel

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• yu Hu

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

• heng Mei

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

• liangjing Lv

  Renji Hospital Shanghai Jiaotong University School of Medical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

medical JW

CONTACT

+86 21 50464201; Relma-celMedical@jwtherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 13, 2023
• Study Start: February 24, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)