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NCT06106893 | RECRUITING | Systemic Lupus Erythematosus

A Clinical Study of CD19 Universal CAR-γδT Cells in Active Systemic Lupus Erythematosus
Sponsor:

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

Information provided by (Responsible Party):

Q IU bail i

Brief Summary:

The purpose of the study is to explore the safety and efficacy of CD19 Universal CAR-γδT cells in active severe systemic lupus erythematosus.

Condition or disease

Systemic Lupus Erythematosus

Intervention/treatment

CD19 Universal CAR-γδ T Cells

Phase

PHASE1

PHASE2

Detailed Description:

The prognosis of patients with active systemic lupus erythematosus (SLE) remains poor, due to two major therapeutic obstacles: (1) current treatment strategies including glucocorticoids, immunosuppressive agents, biological agents, are still difficult to achieve disease control, making the disease condition of some patients continue to be active or even worse; (2) some patients are unable to wean themselves off glucocorticoid and face the risk of numerous adverse effects caused by long-term glucocorticoid dependence, such as glucocorticoid-related diabetes, femoral head necrosis, hypertension, stress ulcers, and infection, etc. Therefore, there is a strong unmet clinical need for more effective treatment for patients suffering from active SLE. Several preclinical studies have shown the efficacy of CAR-T cell treatment in SLE. The aim of this study is to investigate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of CD19 Universal CAR-γδT cells therapy in active SLE. Patients with active SLE will be invited to participate in the study, to receive CD19 Universal CAR-γδT cells intravenous infusion and follow-up visits of up to 2 years after enrollment.

Study Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Single-center Clinical Study Evaluating the Safety and Efficacy of CD19 Universal CAR-γδT Cells in Active Systemic Lupus Erythematosus
Actual Study Start Date : 2024-01-12
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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. Active or latent tuberculosis at screening (can be enrolled if appropriately treated);
  • 12. Any of severe laboratory abnormalities in liver function, renal function, bone marrow function, coagulation function, pulmonary function, cardiac function at screening;
  • 13. 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;
  • 14. Severe heart diseases;
  • 15. Severe hepatobiliary disease;
  • 16. Presence of medical conditions that are obviously unstable or not effectively treated;
  • 17. Presence of uncontrollable bacterial, fungal, viral or other infections, requiring antibiotic therapy;
  • 18. Have received live/attenuated vaccination within 4 weeks prior to screening or plan to receive live/attenuated vaccination throughout the study;
  • 19. Have received any commercially available Janus kinase inhibitor or Bruton tyrosine kinase inhibitor within 3 half-lives 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. Previous 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 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;
  • 25. 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;
  • 26. History of ≥ grade 2 bleeding within 4 weeks prior to screening or need for long-term continuous anticoagulant therapy;
  • 27. Subjects with severe mental illness;
  • 28. Alcoholics or subjects with a history of drug abuse;
  • 29. 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;
  • 30. History of malignancy；
  • 31. 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.
A Clinical Study of CD19 Universal CAR-γδT Cells in Active Systemic Lupus Erythematosus

Location Details

NCT06106893

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Locations

RECRUITING

China, Hubei

Wuhan Union Hospital

Wuhan, Hubei, China, 430022