CD19 CAR-T therapy for active systemic lupus erythematosus

A Single-center Clinical Study Evaluating the Safety and Efficacy of CD19 CAR-T in Active Systemic Lupus Erythematosus

This study is testing a new type of treatment using CD19 CAR-T cells to see if it can help people with active systemic lupus erythematosus who aren't getting enough relief from current medications.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (other)
• Drugs / interventions: CAR-T, prednisone
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06106906 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the safety and efficacy of CD19 CAR-T cell therapy in patients with active systemic lupus erythematosus (SLE). The study will involve administering CD19 CAR-T cells through intravenous infusion to participants who have not achieved adequate disease control with existing treatments. Participants will be monitored for safety, tolerability, and preliminary efficacy over a follow-up period of up to two years. The study addresses the significant unmet need for more effective therapies in managing active SLE, particularly for those struggling with glucocorticoid dependence and its associated side effects.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 diagnosed with active systemic lupus erythematosus who have not responded adequately to standard treatments.

Not a fit: Patients with severe active SLE or known hypersensitivity to the treatment components may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and safer option for patients suffering from active systemic lupus erythematosus.

How similar studies have performed: Preclinical studies have shown promising results for CAR-T cell therapy in systemic lupus erythematosus, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Participants or their 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. Body weight ≥ 40kg;
4. Participants diagnosed with SLE according to the American College of Rheumatology (ACR) 1997 revised criteria for SLE at least 24 weeks prior to signing the informed consent form;
5. Active SLE needs to meet the following criteria at screening:

   SELENA-SLEDAI score ≥ 6 points; PGA ≥ 1 points;
6. Have received at least 8 weeks of standardized treatment for SLE prior to screening;
7. Female participants need to have a negative pregnancy test, and participants agree to take effective contraceptive measures throughout the study.

Exclusion Criteria:

1. Known hypersensitivity to prednisone, immunosuppressive agents;
2. 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;
3. Suicidal ideation within the past 6 months based on assessment by Columbia-Suicide Severity Rating Scale (C-SSRS) at screening; or any suicidal behaviors within the past 12 months or recurrent suicidal behaviors during the subject's lifetime;
4. Presence of SLE or non-SLE related central nervous system diseases or pathological changes within 8 weeks prior to screening;
5. Existence of other lupus crisis within 8 weeks prior to screening;
6. Previous or current diagnosis of non-SLE-related inflammatory arthropathy or skin diseases;
7. Previous or current diagnosis of severe vasculitis due to other diseases excluding SLE;
8. History of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation;
9. Have received plasmapheresis, hemodialysis, intravenous immunoglobulin within 14 days prior to screening;
10. Other autoimmune diseases requiring systemic therapy;
11. Subjects with active viral hepatitis B; Subjects with positive hepatitis C virus (HCV) antibodies; Subjects with positive human immunodeficiency virus (HIV) antibodies; Sujects with positive extracellular DNA quantification of cytomegalovirus (CMV); Sujects with positive extracellular DNA quantification of EB virus (EBV);Subjects tested positive for syphilis;
12. Active or latent tuberculosis at screening (can be enrolled if appropriately treated);
13. Any of severe laboratory abnormalities in liver function, renal function, bone marrow function, coagulation function, pulmonary function, cardiac function at screening;
14. History of severe allergy or known hypersensitivity to any of the active ingredients of the drugs, excipients, or rodent-derived products, xenoproteins included in this trial, or subjects with allergic constitution;
15. Severe heart diseases;
16. Severe hepatobiliary disease;
17. Presence of medical conditions that are obviously unstable or not effectively treated;
18. Presence of uncontrollable bacterial, fungal, viral or other infections, requiring antibiotic therapy;
19. Have received live/attenuated vaccination within 4 weeks prior to screening or plan to receive live/attenuated vaccination throughout the study;
20. Have received any commercially available Janus kinase inhibitor or Bruton tyrosine kinase inhibitor within 3 half-lives prior to screening;
21. Have received B-cell targeted therapy prior to screening;
22. Have received a biologic agent other than B-cell targeted therapy within 5 half-lives prior to screening;
23. Previous received therapies with CAR-T cells or other genetically modified T cells;
24. Have received therapeutic dose of corticosteroids within 7 days prior to leukapheresis or within 72 hours prior to infusion;
25. Have received any other study drugs for SLE within 4 weeks prior to leukapheresis;
26. Subjects that have undergone major surgery within 4 weeks prior to lymph depletion or those who are scheduled to undergo major surgery during the study period, or whose surgical wounds have not fully healed prior to enrollment;
27. Subjects that have donated blood for ≥ 400mL or had significant blood loss equivalent to at least 400mL within 4 weeks prior to screening, or have received a blood transfusion within 8 weeks, or plan to donate blood during the study period;
28. History of ≥ grade 2 bleeding within 4 weeks prior to screening or need for long-term continuous anticoagulant therapy;
29. Subjects with severe mental illness;
30. Alcoholics or subjects with a history of drug abuse;
31. Female subjects who are pregnant or lactating, or intend to pursue pregnancy within 2 years after the cell infusion; male patients whose female sexual partners intend to conceive within 2 years after the cell infusion;
32. History of malignancy；
33. Patients that have contraindications to any of the study procedures or have other medical conditions that may expose them to unacceptable risk, in the judgment of the investigators and/or clinical criteria.

Where this trial is running

Wuhan, Hubei

• Wuhan Union Hospital — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Principal investigator: Qiubai Li, Professor — Department of Rheumatology and Immunology, Wuhan Union Hospital
• Study coordinator: Qiubai Li, Professor

Conditions: Systemic Lupus Erythematosus, systemic lupus erythematosus, CAR-T, CD19