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

NCT06349343 | Recruiting Phase 1

• 1 other identifier: UHCT230949
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Systemic Lupus Erythematosus

Keywords

Refractory/Moderate-to-severe systemic lupus erythematosus; CAR-T cell therapy; CD19; BCMA

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 1 years after CAR-T cell infusion

Secondary Outcomes (6)

• Proportion of subjects with SRI-4 response

  Within 1 years after CAR-T cell infusion(month 1, month 3, month 6, month 9, month 12）

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

  Within 1 years after CAR-T cell infusion(month 1, month 3, month 6, month 9, month 12）

• Changes in the BILAG-2004 score from baseline

  Within 1 years after CAR-T cell infusion(month 1, month 3, month 6, month 9, month 12）

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

  Within 1 years after CAR-T cell infusion(month 1, month 3, month 6, month 9, month 12）

• Pharmacokinetics (PK)

  Within 1 years after CAR-T cell infusion(per 3 days in month 1, per month in month 2 - month 12）

Study Arms (1)

CD19/BCMA CAR-T cell therapy intervention

EXPERIMENTAL

The first 3 participants will be enrolled to receive CAR-T cell infusion without pretreatment chemotherapy. Then participants' peripheral blood samples would be collected for CAR-T cell testing. If test results showed the presence of CAR-T cells on certain time points, CAR-T cell therapy without pretreatment chemotherapy is considered feasible, and the subsequent 17 participants will receive the consistent regimen; Otherwise, the 3 participants will be re-treated with pretreatment chemotherapy and CAR-T cell infusion, and the subsequent 17 participants will receive pretreatment chemotherapy-containing regimen.

Biological: CD19/BCMA CAR-T cell therapy

Interventions

CD19/BCMA CAR-T cell therapy BIOLOGICAL

CD19/BCMA CAR-T cell will be infused intravenously at 3 doses: Dose A, Dose B, Dose C.

CD19/BCMA CAR-T cell therapy intervention

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 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;
• Age range from 18 to 70 years old, regardless of gender;
• 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;
• 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;
• Participants with fertility agree to take effective contraceptive measures throughout the study and within 3 months after the last follow-up visit.

You may not qualify if:

• 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;
• Any attempted suicide or suicidal ideation within the past year prior to screening;
• Presence of SLE or non-SLE related central nervous system diseases or pathological changes within 8 weeks prior to screening;
• Previous or current diagnosis of non-SLE-related inflammatory arthropathy or skin diseases;
• History of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation;
• History of lymphoproliferative diseases;
• Subjects with malignancy within 5 years prior to screening;
• Have received plasma exchange, plasma separation, hemodialysis, or intravenous immunoglobulin (IVIG) within 14 days prior to screening;
• Other autoimmune diseases requiring systemic therapy;
• 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;
• Active or latent tuberculosis at screening;
• Abnormalities in major organ function at screening;
• Previous or current diagnosis of acute or chronic illnesses unrelated to SLE with obviously unstable or uncontrollable clinical symptoms;
• Severe lupus lung damage at screening;
• Severe lupus cardiac damage at screening;

Sponsors & Collaborators

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

Study Sites (1)

Union Hospital Tongji Medical College HUAZHONG University of Science and Technology

Wuhan, 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

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

  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: Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 5, 2024
• Study Start: February 10, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)