UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases

NCT06978738 | Not Yet Recruiting Phase 1

• 1 other identifier: QH-CE-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.

Conditions

Systemic Lupus Erythematosus; Autoimmune Hemolytic Anemia; Myasthenia Gravis; Systemic Sclerosis; ANCA-Associated Vasculitis; Inflammatory Myopathy; IgG4-RD

Keywords

Universal Allogeneic CAR T-cells; CD19/BCMA CAR T-cells

Outcome Measures

Primary Outcomes (2)

• The number and severity of dose-limiting toxicity (DLT) events

  DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.

  Within 28 Days After UCAR T-cell Infusion

• The total number, incidence, and severity of AEs

  Up to 90 days After UCAR T-cell Infusion

Secondary Outcomes (9)

• AIHA：Rates of CR, CRi, PR, ORR

  Up to 24 Months After UCAR T-cell Infusion

• SLE：SLE Response Index 4 (SRI-4)

  Up to 24 Months After UCAR T-cell Infusion

• SLE: Change in the Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) from baseline

  Up to 24 Months After UCAR T-cell Infusion

• SSc：Change in the modified Rodnan Skin Score (mRSS) from baseline

  Up to 24 Months After UCAR T-cell Infusion

• IIM：The ACR-EULAR Myositis Response Criteria [Total Improvement Score (TIS)]

  Up to 24 Months After UCAR T-cell Infusion

Study Arms (1)

UCAR T-cell group

EXPERIMENTAL

A single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells

Biological: universal allogeneic anti-CD19/BCMA CAR T-cells

Interventions

universal allogeneic anti-CD19/BCMA CAR T-cells BIOLOGICAL

A single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells

UCAR T-cell group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old (inclusive), regardless of gender.
• Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.
• Functional requirements for major organs are as follows:
• Bone marrow function must meet: A. Neutrophil count ≥ 0.5×10 \^ 9/L (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g/L; C. Platelets ≥ 30 × 10 \^ 9/L.
• Liver function: Alanine aminotransferase (ALT) ≤ 3×ULN (excluding ALT elevation due to inflammatory myopathy), aspartate aminotransferase (AST)≤3×Upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy), TBIL≤1.5×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome);
• Renal function: creatinine clearance rate (CrCl) ≥ 30ml/minute (calculated by Cockcroft/Gault formula, acute CrCl decrease due to the target disease is excluded; LN is exluded);
• ECOG score 0-1.
• Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.
• Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
• Subjects with relapsed or refractory autoimmune diseases, Including relapsed or refractory Autoimmune Hemolytic Anemia, relapsed or refractory Systemic Lupus Erythematosus, relapsed or refractory or Progressive Systemic Sclerosis, relapsed or refractory or Progressive Inflammatory Myopathy, relapsed or refractory ANCA-Associated Vasculitis, relapsed or refractory Immunoglobulin-G4 related disease and relapsed or refractory Myasthenia Gravis.

You may not qualify if:

• Subjects with a history of severe drug allergies or allergic constitutions;
• \. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections;
• \. Subjects with insufficient cardiac function;
• \. Subjects with congenital immunoglobulin deficiencies;
• \. Subjects with a history of malignant tumors within the past five years, except for the following conditions: non-melanoma skin cancer, stage I tumors with a low recurrence probability after complete resection, clinically localized prostate cancer after treatment, cervical carcinoma in situ confirmed by biopsy or squamous intraepithelial lesion shown by smear, and stable papillary thyroid carcinoma or follicular thyroid carcinoma.
• \. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \>ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing;
• \. Subjects with mental illness and severe cognitive dysfunction;
• \. Pregnant women or women planning to conceive;

Sponsors & Collaborators

• Changzhou No.2 People's Hospital: lead

Study Sites (1)

Changzhou No.2 People's Hospital

Changzhou, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Anemia, Hemolytic, Autoimmune; Myasthenia Gravis; Scleroderma, Systemic; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Myositis; Immunoglobulin G4-Related Disease

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Skin Diseases; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Muscular Diseases; Musculoskeletal Diseases

Central Study Contacts

Xuzhang Lu, Doctor

CONTACT

+86-15295189493; Luxuzhang2008@163.com

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: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 18, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)