A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Systemic Lupus Erythematosus

NCT05030779 | Unknown Early Phase 1 DMC

• 1 other identifier: CD19/BCMA-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Systemic Lupus Erythematosus

Conditions

Systemic Lupus Erythematosus; Autoimmune Diseases

Keywords

Systemic Lupus Erythematosus; CD19 CAR T-cell therapy; BCMA CAR T-cell therapy

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Adverse events assessed according to NCI-CTCAE v5.0 criteria

  Baseline up to 28 days after CD19/BCMA CAR T-cells infusion

• Incidence of treatment-emergent adverse events (TEAEs)

  Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

  Up to 90 days after CD19/BCMA CAR T-cells infusion

Secondary Outcomes (7)

• Autoantibody detection

  Up to 90 days after CD19/BCMA CAR T-cells infusion

• Concentration of CAR-T cells

  From admission to the end of the follow-up, up to 2 years

• Objective Response Rate, ORR

  In 3 months of CD19/BCMA CAR-T cell infusion

• Disease control rate, DCR

  From Day 28 CD19/BCMA CAR-T infusion up to 2 years

• Duration of remission, DOR

  24 months post CD19/BCMA CAR-T cells infusion

Study Arms (1)

Treatment of SLE

EXPERIMENTAL

Experimental：Administration of CD19/BCMA CAR T-cells A dose levels of 1-4\*10E6/kg are administrated for each subject.

Biological: Assigned Interventions CD19/BCMA CAR T-cells

Interventions

Assigned Interventions CD19/BCMA CAR T-cells BIOLOGICAL

Drug: CD19/BCMA CAR T-cells Each subject receive CD19/BCMA CAR T-cells by intravenous infusion Other Name: CD19/BCMA CAR T-cells injection

Treatment of SLE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemic lupus erythematosus with positive CD19/BCMA expression , and the conventional treatment is not effective and (or) no effective treatment
• Estimated survival time\> 12 weeks;
• Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up;
• Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

You may not qualify if:

• History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
• Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• Pregnant (or lactating) women;
• Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
• Active infection of hepatitis B virus or hepatitis C virus;
• Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
• Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
• Other uncontrolled diseases that were not suitable for this trial;
• Patients with HIV infection;
• Any situations that the investigator believes may increase the risk of patients or interfere with the results of study
• Platelets ≥30×10E9/L, and absolute lymphocyte count ≥1.0×10E9/L
• Methylprednisolone (maximum dose 1mg/kg) or prednisone (maximum dose 1.25mg/kg) instead of immunosuppressive agents to control the disease.

Sponsors & Collaborators

• Zhejiang University: lead
• Yake Biotechnology Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital,College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Related Publications (1)

• Feng J, Huo D, Hong R, Jin X, Cao H, Shao M, Wen R, Zhang Q, Zhang M, Fu S, Wang D, Xu H, Wei G, Cui J, Huang S, Cui D, Chang AH, Liu Z, Lu L, Lin J, Hu Y, Huang H. Co-infusion of CD19-targeting and BCMA-targeting CAR-T cells for treatment-refractory systemic lupus erythematosus: a phase 1 trial. Nat Med. 2025 Nov;31(11):3725-3736. doi: 10.1038/s41591-025-03937-8. Epub 2025 Sep 24.

  PMID: 40993243 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Autoimmune Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• He Huang, PhD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, PhD

CONTACT

86-13605714822; hehuangyu@126.com

Yongxian Hu, PhD

CONTACT

86-15957162012; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: September 1, 2021
• Study Start: September 10, 2021
• Primary Completion: March 10, 2022
• Study Completion: September 10, 2022
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

CN (1)