CD19/BCMA UCAR-T for B Cell-Related Autoimmune Disease

Recruiting now · Early Phase 1

Conditions studied: Autoimmune Diseases, Systemic Lupus Erthematosus (SLE), Multi-Drug Resistant Nephrotic Syndrome, IgA Nephropathy (IgAN), Systemic Sclerosis (SSc), ANCA Associated Systemic Vasculitis

In brief

This is an exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219CX. QT-219CX is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard "3+3" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219CX .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .

Key facts

Study ID

NCT07586267

Run by

The Children's Hospital of Zhejiang University School of Medicine

People needed

15

Starts

2026-05-08

Expected to finish

2030-12-31

Last updated by the study team

2026-05-14

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Common Inclusion Criteria:
• 1.Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):
• Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; b. Hemoglobin ≥ 60 g/L; c. Platelet count ≥ 30 × 10⁹/L.
• Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).
• Renal Function: eGFR ≥ 30 mL/min/1.73 m².(Participants with eGFR < 30 mL/min/1.73 m² and/or those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)
• Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.
• Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%.
• 2.Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.
• 3.Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.
• Disease-Specific Inclusion Criteria
• SLE:
• 1.Age ≥ 5 years.
• 2.Meets the 2012 SLICC or 2019 EULAR/ACR classification criteria for SLE.
• 3.Must meet at least one of the following adequate treatment conditions:
• Active disease persists despite adequate treatment with glucocorticoids (≥1 mg/kg/day prednisone or equivalent dose of other corticosteroids) in combination with at least two immunosuppressants or biologic agents for at least 3 months, or affected organ function has failed to improve; or inability to taper glucocorticoid dosage to ≤5 mg/day after 6 months of conventional treatment;
• Patients who have developed intolerable drug toxicity during conventional therapy, or have contraindications precluding standard treatment, or have experienced multiple treatment failures-may be considered for enrollment following full informed consent by the investigator and the patient or legal guardian;
• SLEDAI-2K Criteria: SLEDAI-2K score ≥8; or SLEDAI-2K score ≥6 combined with at least one BILAG-2004 Category A or two Category B organ system involvements (or both)；Patients with severe refractory SLE-ITP, characterized by a platelet count of <30×10⁹/L or <50×10⁹/L accompanied by bleeding tendency, regardless of the SLEDAI-2K score.
• 4.No occurrence of macrophage activation syndrome within 1 month prior to screening.
• 5.Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.
• MDR-SRNS
• 1.Age ≥3 years old, gender unlimited.
• 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;
• 3. Must meet at least one of the following adequate treatment conditions:
• have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Telitacicept or rituximab).
• if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.

You may not qualify if…

• 1. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.
• 2.Subjects with grade III or IV heart failure (NYHA classification).
• 3.Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.
• 4. Uncontrollable infection, or active infection that requires systemic treatment at screening.
• 5. Had active pulmonary tuberculosis at screening.
• 6. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.
• 7. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.
• 8. Patients had active central nervous system disease.
• 9. Patients with malignant diseases such as tumors before screening.
• 10. Secondary or congenital immunodeficiency.
• 11. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.
• 12. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.
• 13. Received live vaccine within 4 weeks before screening.
• 14. Tested positive in Blood pregnancy test.
• 15. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.
• 16. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.
• 17. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.

Where it is running

• Children's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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