Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Moderate to Severe Active SLE Clinical Research

NCT06711146 | Recruiting Early Phase 1

• 1 other identifier: Meta10-19-007
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Moderate to Severe Active Systemic Lupus Erythematosus

Conditions

Systemic Lupus Erythematosus

Keywords

Meta10-19; CAR-T Cells Therapy; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• MTD

  Determine the Maximal Tolerable Dose(MTD).

  MTD will be determined based on DLTs observed during the first 35 days of study treatment.

• DCR

  Disease control rates (DCR) assessed according to SLEDAI-2000, Physician Overall Assessment (PGA), and medication.

  3 and 6 months following infusion of Meta10-19.

Secondary Outcomes (3)

• Concentration of CAR-T cells

  Up to 12 months after CAR-T treatment.

• Pharmacodynamics of CAR-T cells

  Up to 28 days after infusion.

• Autoantibody detection

  Up to 12 months after CAR-T treatment

Study Arms (1)

Administration of Metabolically Armed CD19 CAR-T cells

EXPERIMENTAL

Patients undergo leukapheresis. Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CAR-T cells infusion. A dose of metabolically armed CD19 CAR-T cells will be infused on day 0.

Drug: Metabolically Armed CD19 CAR-T cells

Interventions

Metabolically Armed CD19 CAR-T cells DRUG

Each subject receive metabolically armed CD19 CAR- T cells by intravenous infusion

Also known as: Meta10-19

Administration of Metabolically Armed CD19 CAR-T cells

Eligibility Criteria

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

You may qualify if:

• All subjects or guardians must sign an informed consent form approved by the Ethics Committee in person before commencing any screening process;
• Be over 18 years of age, male or female;
• A diagnosis of SLE according to the 2012 systemic lupus international collaborating clinics(SLICC);
• 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:
• Conventional regimens for SLE are corticosteroids and one or more immunomodulatory drugs over 6 months；
• Oral corticosteroids must meet the following requirements:
• Prednisone (or equivalent) ≥7.5 mg/ day, and ≤60 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；
• Women of childbearing age and all male patients must consent to use a effective contraception for at least 12 months after Meta10-19 infusion and until two consecutive PCR tests show no more CAR T cells in vivo;
• CD19 expression was positive by or flow cytometry ;
• Organ function：
• Complete blood count (CBC) test \[the following criteria should be met within 24 hours prior to apheresis, and supportive treatment such as transfusion, platelet transfusion, cell growth factor (except recombinant erythropoietin) should be avoided within 7 days prior to detection\]

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).
• Other conditions that the investigator considered should not be enrolled in this clinical study.

Sponsors & Collaborators

• Zhejiang University: lead
• Leman Biotech Co., Ltd.: collaborator

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mingming Zhang

CONTACT

86-13656674208; mingmingzhang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: December 24, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 5, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)