Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE

NCT06892145 | Recruiting Phase 1

• 1 other identifier: PB13
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

This is a single-arm, open, dose-increasing and dose-expanding phase I clinical trial to investigate the safety, tolerability and cytodynamic characteristics of MC-1-50 cell preparation, and to preliminatively observe the efficacy of MC-1-50 cell preparation in patients with refractory SLE, and to explore the applicable dose regimen for phase II clinical trials.

Conditions

Refractory; Systemic Lupus Erythematosus (SLE)

Keywords

CAR T-Cell therapy; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Dose-limiting toxicity after CD19 CAR-T cell infusion

  1 month

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute\'s Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)

  1 month

Secondary Outcomes (6)

• Validity endpoint of MC-1-50 cells [Efficacy]

  3 months

• AUCS of MC-1-50 cells [Cell dynamics]

  3 months

• CMAX of MC-1-50 cell preparation [Cell dynamics]

  3 months

• TMAX of MC-1-50 cell preparation[Cell dynamics]

  3 months

• Pharmacodynamics of MC-1-50 cell preparation[Cell dynamics]

  3 months

Other Outcomes (2)

• Response rate after MC-1-50 infusion [Long-term Efficacy]

  2 years

• The rebuilding of the immune system

  2 years

Study Arms (1)

MC-1-50

EXPERIMENTAL

Patients will be be treated with CD19 CAR- T cells

Biological: MC-1-50

Interventions

MC-1-50 BIOLOGICAL

A single infusion of CD19 CAR-T cells will be administered intravenously after lymphodepletion chemotherapy

MC-1-50

Eligibility Criteria

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

You may qualify if:

• The patient or their guardian agrees to participate in this clinical trial and sign the ICF, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study;
• Age ≥ 18 years old , gender not limited;
• Patients diagnosed with SLE according to the 2019 EULAR/ACR classification criteria,And by hydroxychloroquine, sufficient glucocorticoid (≥1mg/kg/d prednisone or equivalent amount of other hormones), to less than 2Treatment with immunosuppressants (including cyclophosphamide, motecophanate, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, etc.), and at least one approved biological agent (including titacept, Beliuzumab, etc.), with a total duration of treatment ≥3 months, still in a disease active state, or unable to tolerate conventional therapy;
• SLEDAI-2K score ≥7 points;
• Autoantibody test results are positive: ANA antibody positive and/or serum anti-DSDNA positive;
• Adequate renal, hepatic, pulmonary and cardiac function defined as:
• Cardiac function: Echocardiography indicates left ventricular ejection fraction ≥ 50%;
• Renal function: serum creatinine ≤ 2.0 × ULN, or creatinine clearance rate ≥ 60ml/min (Cockcroft Gault formula);
• Hepatic function: ALT and AST ≤ 3.0 × ULN (may be relaxed to ≤ 3.0 × ULN in cases of combined liver infiltration);
• Total bilirubin ≤ 2.0 × ULN (Gilbert syndrome requires total bilirubin ≤ 3.0 × ULN);
• Pulmonary function: Blood oxygen saturation is ≥ 92% in non oxygen state.
• No serious mental disorders;
• Meet standards for apheresis or venous blood collection, and no other cell collection contraindications;
• Women of childbearing age who have a negative blood pregnancy test and all subjects agree to use reliable and effective contraceptive methods (excluding safe period contraception) for contraception within one year after receiving MC-1-50 cell infusion from the time of signing the informed consent form. Including but not limited to: abstinence, implantable progestogen contraceptives that can inhibit ovulation; Intrauterine device (IUD); Intrauterine hormone release system; Spouse vasectomy; Compound hormone contraceptives that can inhibit ovulation (oral, vaginal, and transdermal); Progesterone contraceptives (oral or injectable) that can inhibit ovulation; When male subjects have sex with fertile women, they must agree to use barrier contraception (such as condom plus spermicidal foam/gel/film/emulsion/suppository). At the same time, participants should commit not to donate eggs (oocytes, oocytes) or sperm for assisted reproduction within one year after cell infusion.

You may not qualify if:

• There were severe active central nervous system lupus that required therapeutic intervention at the time of screening;
• Acute severe nephritis: had or was undergoing renal replacement therapy within 3 months prior to reinfusion, or had significant renal deterioration that the investigator believed was likely to cause the subject to require high doses of corticosteroids (prednisone ≥1mg/kg/ day or equivalent of other hormones), cyclophosphamide, or mycophanate during the first 3 months of the study;Clinical stable lupus nephritis that can be controlled during screening can be considered;
• There were other lupus crises that were not controlled at the time of screening;
• Individuals who have received CAR-T therapy or other gene modified cell therapies;
• Combined with other autoimmune diseases requiring systemic treatment;
• HBsAg or HBcAb positive and HBV DNA test greater than the normal range;HCV antibody positive and HCV RNA detection greater than the normal range;HIV antibody positive;Treponema pallidum antibody positive;
• Suffered from any of the following heart diseases:
• New York Heart Association (NYHA) stage III or IV congestive heart failure;
• Within the 6 months prior to enrollment, there has been a myocardial infarction, or a coronary artery bypass grafting (CABG) or stent implantation surgery has been performed;
• History of ventricular arrhythmias requiring treatment or unexplained syncope (excluding cases caused by vasovagal or dehydration);
• History of severe non-ischemic cardiomyopathy;
• Uncontrollable infection in the 1 weeks before enrollment;
• History of solid organ transplantation or hematopoietic stem cell transplantation prior to screening；
• Cerebrovascular accident or seizure occurred within 6 months prior to screening；
• Deep vein or deep artery embolism event within the past 6 months prior to screening;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Chongqing Precision Biotech Co., Ltd: lead

Study Sites (2)

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Jing Xue, M.D.

CONTACT

+8613858121751; xuej@zju.edu.cn

Zhu Chen, M.D.

CONTACT

+8613956963042; doczchen@gmail.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: March 18, 2025
• First Posted: March 24, 2025
• Study Start: June 12, 2025
• Primary Completion: May 4, 2026
• Study Completion (Estimated): February 16, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)