A Clinical Study of CD19 CAR-T in Active Systemic Lupus Erythematosus

NCT06106906 | Recruiting Phase 1

• 1 other identifier: UHCT230444
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Systemic Lupus Erythematosus

Keywords

systemic lupus erythematosus; CAR-T; CD19

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Safety and tolerability will be assessed by incidence and severity of adverse events (AEs) and serious AEs (SAEs). Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are graded by ASTCT criteria, other AEs are assessed by CTCAE V5.0 criteria

  Within 2 years after CD19 CAR-T cell infusion

Secondary Outcomes (11)

• Pharmacokinetics (PK)

  Within 2 years after CD19 CAR-T cell infusion

• Pharmacodynamics (PD)

  Within 28 days after CD19 CAR-T cell infusion

• Proportion of subjects with SRI-4 response

  Within 2 years after CD19 CAR-T cell infusion (day 14, day 28, month 3, month 6, month 9, month 12, month 18, month 24)

• Changes in the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score from baseline

  Within 2 years after CD19 CAR-T cell infusion (day 14, day 28, month 3, month 6, month 9, month 12, month 18, month 24)

• Changes in the Physician Global Assessment (PGA) score from baseline

  Within 2 years after CD19 CAR-T cell infusion (day 14, day 28, month 3, month 6, month 9, month 12, month 18, month 24)

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Participants will receive CD19 CAR-T cell intravenous infusion

Biological: CD19 CAR-T cell infusion

Interventions

CD19 CAR-T cell infusion BIOLOGICAL

CD19 CAR-T cell intravenous infusion

Experimental Arm

Eligibility Criteria

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

You may qualify if:

• 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;
• Age range from 18 to 70 years old, regardless of gender;
• Body weight ≥ 40kg;
• 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;
• Active SLE needs to meet the following criteria at screening:
• SELENA-SLEDAI score ≥ 6 points; PGA ≥ 1 points;
• Have received at least 8 weeks of standardized treatment for SLE prior to screening;
• Female participants need to have a negative pregnancy test, and participants agree to take effective contraceptive measures throughout the study.

You may not qualify if:

• Known hypersensitivity to prednisone, immunosuppressive agents;
• 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;
• 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;
• Presence of SLE or non-SLE related central nervous system diseases or pathological changes within 8 weeks prior to screening;
• Existence of other lupus crisis within 8 weeks prior to screening;
• Previous or current diagnosis of non-SLE-related inflammatory arthropathy or skin diseases;
• Previous or current diagnosis of severe vasculitis due to other diseases excluding SLE;
• History of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation;
• Have received plasmapheresis, hemodialysis, intravenous immunoglobulin within 14 days prior to screening;
• Other autoimmune diseases requiring systemic therapy;
• 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;
• Active or latent tuberculosis at screening (can be enrolled if appropriately treated);
• Any of severe laboratory abnormalities in liver function, renal function, bone marrow function, coagulation function, pulmonary function, cardiac function at screening;
• 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;
• Severe heart diseases;

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Guangzhou Bio-gene Technology Co., Ltd: collaborator

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

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

Study Officials

• Qiubai Li, Professor

  Department of Rheumatology and Immunology, Wuhan Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiubai Li, Professor

CONTACT

85726808; qiubaili@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. & Ph.D., Professor

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 30, 2023
• Study Start: June 19, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)