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

NCT06106893 | Recruiting Phase 1

• 1 other identifier: UHCT230443
• 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 Universal CAR-γδT cells in active severe systemic lupus erythematosus.

Conditions

Systemic Lupus Erythematosus

Keywords

systemic lupus erythematosus; CD19 Universal CAR-γδ T Cells

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 Universal CAR-γδT cell infusion

Secondary Outcomes (11)

• Pharmacokinetics (PK)

  Within 2 years after CD19 Universal CAR-γδT cell infusion

• Pharmacodynamics (PD)

  Within 28 days after CD19 Universal CAR-γδT cell infusion

• Proportion of subjects with SRI-4 response

  Within 2 years after CD19 Universal CAR-γδT 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 Universal CAR-γδT 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 Universal CAR-γδT 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 Universal CAR-γδ T Cells intravenous infusion

Biological: CD19 Universal CAR-γδ T Cells

Interventions

CD19 Universal CAR-γδ T Cells BIOLOGICAL

Intravenous infusion of CD19 Universal CAR-γδ T Cells

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;
• 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;
• Severe hepatobiliary disease;

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: January 12, 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)