NCT06349343 CD19/BCMA CAR-T Cell Therapy for Refractory/Moderate-to-severe Systemic Lupus Erythematosus

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 20 participants in total. It began in 2025-02-10 with a primary completion date of 2026-01.

Brief Summary

The purpose of the study is to explore the safety and efficacy of cluster of differentiation 19 (CD19)/B cell maturation antigen (BCMA) CAR-T cell therapy in refractory/moderate-to-severe systemic lupus erythematosus(SLE).

Eligibility Criteria

Inclusion Criteria: 1. Participants or their legal guardians understand and voluntarily sign the informed consent form, and be able to complete all the documents, procedures, follow-up examinations and treatments specified in the study protocol, with good compliance; 2. Age range from 18 to 70 years old, regardless of gender; 3. Participants diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)/the American College of Rheumatology (ACR) SLE criteria at least 24 weeks prior to screening; 4. Refractory/moderate-to-severe SLE needs to meet the following criteria at screening: SELENA-SLEDAI score \> 6 points; PGA ≥ 1 points; BILAG-2004 organ system scores of at least 1 A or 2 B;Have received at least 12 weeks of standardized treatment for SLE prior to screening but lack efficacy; 5. Participants with fertility agree to take effective contraceptive measures throughout the study and within 3 months after the last follow-up visit. Exclusion Criteria: 1. Diagnosis of active severe lupus nephritis within 8 weeks prior to screening, requiring medications prohibited by the research protocol for active nephritis, hemodialysis or prednisone ≥ 100 mg/d, or equivalent glucocorticoid therapy for ≥14 days; 2. Any attempted suicide or suicidal ideation within the past year prior to screening; 3. Presence of SLE or non-SLE related central nervous system diseases or pathological changes within 8 weeks prior to screening; 4. Previous or current diagnosis of non-SLE-related inflammatory arthropathy or skin diseases; 5. History of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation; 6. History of lymphoproliferative diseases; 7. Subjects with malignancy within 5 years prior to screening; 8. Have received plasma exchange, plasma separation, hemodialysis, or intravenous immunoglobulin (IVIG) within 14 days prior to screening; 9. Other autoimmune diseases requiring systemic therapy; 10. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV DNA titer in peripheral blood higher than the lower limit of research institution's test range. Subjects with positive hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies, or syphilis; 11. Active or latent tuberculosis at screening; 12. Abnormalities in major organ function at screening; 13. Previous or current diagnosis of acute or chronic illnesses unrelated to SLE with obviously unstable or uncontrollable clinical symptoms; 14. Severe lupus lung damage at screening; 15. Severe lupus cardiac damage at screening; 16. Presence of uncontrollable infections at screening, requiring antibiotic therapy; 17. Have received live/attenuated vaccination within 4 weeks prior to screening or plan to receive live/attenuated vaccination throughout the study; 18. Have received intra-articular, intramuscular or intravenous glucocorticoids within 4 weeks prior to screening; 19. Have received any commercially available Janus kinase (JAK) inhibitor or Bruton tyrosine kinase (BTK) inhibitor within 12 weeks prior to screening; 20. Have received B-cell targeted therapy prior to screening; 21. Have received a biologic agent other than B-cell targeted therapy within 5 half-lives prior to screening; 22. Previously received therapies with CAR-T cells or other genetically modified T cells; 23. Have received therapeutic dose of corticosteroids within 7 days prior to leukapheresis or within 72 hours prior to infusion; 24. Subjects that have donated blood for ≥ 400mL or had a significant blood loss equivalent to at least 400mL within 4 weeks prior to screening, or have received blood transfusion within 8 weeks, or plan to donate blood during the study period; 25. History of ≥grade 2 bleeding within 4 weeks prior to screening or need for long-term continuous anticoagulant therapy; 26. Subjects that have undergone any major surgeries within 12 weeks prior to screening, or those who are scheduled to undergo major surgery during the study period; 27. History of drug abuse within 12 weeks prior to screening; 28. Female subjects who are pregnant or lactating, or intend to conceive within 2 years after the cell infusion; male patients whose female partners intend to conceive within 2 years after the cell infusion; 29. History of any significant drug allergy or intolerance; 30. Subjects that have participated in other clinical trials within 3 months prior to screening and/or currently participated in other clinical trials (those who do not receive study drugs are excluded); 31. Presence of other circumstances that make the subjects not eligible for participation in the study, in the opinion of the researchers.

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