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Universal CAR-T Cell Therapy for Refractory Lupus Nephritis | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGEARLY_PHASE1

Universal CAR-T Cell Therapy for Refractory Lupus Nephritis

A Clinical Study of the Safety and Efficacy of Universal CAR-T Cells Targeting BCMA and CD19 for the Treatment of Refractory Lupus Nephritis

NCT06681337•Bioray Laboratories

View on ClinicalTrials.gov

Summary

This investigator-initiated trial aims to assess the efficacy and safety of combination therapy using universal CAR-T cells targeting BCMA and CD19 in refractory lupus nephritis.

Detailed Description

This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of combination therapy for refractory lupus nephritis using universal CAR-T cells targeting BCMA and CD19.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged 18-65 years; both genders eligible.
•Subjects diagnosed with lupus nephritis.
•Previous treatment outcomes were unsatisfactory.
•Diagnosis of active nephritis type III or IV with or without type V according to 2018 International Society of Nephrology and Society of Renal Pathology (ISN/RPS) criteria.
•NIH Activity Index \> 2 and elevated chronicity index.
•Urine protein: creatinine ratio (UPCR) ≥ 1.0 g/g, or 24-hour urine protein ≥ 1.0 g, with or without active urine sediment with red blood cell casts.
•Receiving hormones with or without antimalarials.
•SLEDAI-2K score ≥ 6.
•Antinuclear antibody positive, and/or anti-ds-DNA antibody positive, and/or anti-Smith antibody positive.
•Positive expression of CD19 on B cells in peripheral blood.
+2 more criteria

Exclusion Criteria

•History of solid organ transplantation.
•Malignant tumor within the last two years.
•Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.
•Primary immunodeficiency (congenital or acquired).
•Severe cardiac disease.
•History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.
•Allergic constitution or a history of severe allergies.
•Pregnant or breastfeeding women.

Key Dates

Start Date

November 25, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

November 8, 2024

Enrollment

ESTIMATED participants

Conditions

Lupus Nephritis

Interventions

BCMA CART + CD19 CART

BIOLOGICAL

Contacts

Dandan Wang, PhD

CONTACT

15850515316 dangdangwang2007@163.com

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RECRUITINGPHASE2

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

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Lupus Erythematosus, SystemicLupus Nephritis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Universal CAR-T Cell Therapy for Refractory Lupus Nephritis

Inclusion Criteria

Exclusion Criteria

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH

Safety and Efficacy of ONT01 in Lupus

Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial

Lupus Landmark Study: A Prospective Registry and Biorepository