Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases

NCT07161193 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: L2025021-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases

Conditions

Autoimmune Diseases

Keywords

Autoimmune Diseases

Outcome Measures

Primary Outcomes (3)

• Phase I:Cytokine Release Syndrome (CRS)

  The incidence and severity of Cytokine Release Syndrome (CRS)

  28 days post infusion

• Phase I：Immune Effector Cell-Associated Neurotoxicity Syndrome(ICANS)

  The incidence and severity of Immune Effector Cell-Associated Neurotoxicity Syndrome(ICANS)

  28 days post infusion

• Phase II: Efficacy:Objective response rate (ORR)

  Proportions of subjects achieving Autoimmune Diseases response

  3 months and 6 months post infusion

Secondary Outcomes (14)

• AUCS of CAR-T cells [Cell dynamics]

  Up to 6 months post infusion

• CMAX of CD19 CAR T cells [Cell dynamics]

  Up to 6 months post infusion

• TMAX of CD19 CAR T cells [Cell dynamics]

  Up to 6 months post infusion

• CAR-T proliferation [Cell dynamics]

  Up to 6 months post infusion

• Pharmacodynamics of CD19 CAR T cells

  Up to 6 months post infusion

Study Arms (1)

Experimental :CD19 CAR

EXPERIMENTAL

Following the lymphodepleting treatment, patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.

Biological: CD19 CAR-T cells

Interventions

CD19 CAR-T cells BIOLOGICAL

Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.

Experimental :CD19 CAR

Eligibility Criteria

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

You may qualify if:

• Refractory Moderate-to-Severe Systemic lupus erythematosus (SLE) 1.1.Age 18-70 years. 1.2.Estimated life expectancy ≥ 3 months. 1.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 1.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
• Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
• Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.
• Required laboratory tests, including but not limited to: CBC, urinalysis, ANA, anti-dsDNA, ENA panel, C3/C4, immunoglobulins, antiphospholipid antibodies, etc.
• Meets current international or domestic classification criteria: the 1997 ACR SLE classification criteria OR the 2019 EULAR/ACR SLE classification criteria, and is judged to have moderate-to-severe SLE.
• SELENA-SLEDAI score ≥ 8; PGA ≥ 1; and at least one BILAG-2004 organ-system score of 1A or 2B.
• Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.
• Refractory Idiopathic inflammatory myopathy (IIM) 2.1.Age 18-70 years. 2.2.Estimated life expectancy ≥ 3 months. 2.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 2.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
• Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
• Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.
• Fulfillment of the 2017 EULAR/ACR classification criteria for dermatomyositis or polymyositis.
• Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.
• Refractory Systemic sclerosis (SSc) 3.1.Age 18-70 years. 3.2.Estimated life expectancy ≥ 3 months. 3.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 3.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
• Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
• Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.

You may not qualify if:

• (1) Clinically significant (as determined by the investigator) history of cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases.
• (2) Pregnant or lactating women. (3) History of active tuberculosis (TB) infection within 3 years prior to the screening visit.
• (4) History of traumatic brain injury, altered consciousness, epilepsy, cerebral ischemia, or any cerebrovascular hemorrhagic disorders.
• (5) Prolonged QT interval on ECG or history of severe arrhythmias or other significant cardiac disorders.
• (6) Active infection (excluding uncomplicated urinary tract infection and bacterial pharyngitis).
• (7) Active hepatitis B virus or hepatitis C virus infection. (8) Confirmed positive anti-HIV antibody test. (9) Positive Treponema pallidum antibody test judged by the investigator to be clinically significant.
• (10) Any known or suspected congenital or acquired immunodeficiency that may compromise the subject's immune status.
• (11) Prior treatment with CD19 CAR-T cell therapy or CD19-targeted antibody drugs.
• (12) Prior exposure to any gene therapy. (13) ALT/AST \> 3× ULN, or bilirubin \> 2.0× ULN, or serum creatinine \> 2× ULN, or creatinine clearance \< 30 mL/min.
• (14) Any condition that, in the opinion of the investigator, may increase patient risk or interfere with study results.

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead
• The Second Affiliated Hospital of Henan University of Science and Technology, Luoyang, China: collaborator
• Henan Province Engineering Technology Research Center of Immunological Precision Medicine and Artificial Intelligence Application, Luoyang, China: collaborator

Study Sites (1)

Henan Province Engineering Technology Research Center of Immunological Precision Medicine and Artificial Intelligence Application, The Second Affiliated Hospital of Henan University of Science and Technology, Luoyang, China

Luoyang, Henan, 471003, China

Location

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Huirui Wang, M.D.

  Henan Province Engineering Technology Research Center of Immunological Precision Medicine and Artificial Intelligence Application, The Second Affiliated Hospital of Henan University of Science and Technology, Luoyang, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huirui Wang, M.D.

CONTACT

+86-0379-63307832; wanghuirui7873@163.com

Songyun Wang, M.D.

CONTACT

15237998132@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 8, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): August 18, 2027
• Study Completion (Estimated): November 18, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)