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Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases

NCT06316791•Juventas Cell Therapy Ltd.

View on ClinicalTrials.gov

Summary

Exploratory clinical study of CNCT19 anti CD19 cell therapy in the treatment of refractory autoimmune diseases,To evaluate the safety and tolerability of CNCT19 in patients with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia), refractory ANCA-associated vasculitis, and refractory dermatomyositis on the basis of standard of care.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The enrolled subjects or their legal representatives signed informed consent form;
•2. age range: 18-70 years (including 18 and 70 years), male or female;
•3. Subjects with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia) : Diagnosed with systemic lupus erythematosus according to American College of Rheumatology (ACR) criteria, accompanied by lupus nephritis (SLE-LN) or immune thrombocytopenia (SLE-ITP) and receiving standard treatment;
•1. Subjects with Refractory Systemic Lupus Erythematosus (Lupus Nephritis): Active and biopsy-confirmed proliferative lupus nephritis grade III or IV or simple grade V alone according to 2003 ISN/RPS criteria. Active renal disease was defined as a urine protein: creatinine ratio \> 1.0 or proteinuria \> 3.5 grams/day.
•2. Subjects with refractory systemic lupus erythematosus (thrombocytopenia): At least two consecutive blood routine examinations showed that platelet was lower than 50x109/L; Blood cell morphology of peripheral blood smear was normal. The spleen is generally not enlarged; The morphological characteristics of bone marrow cells were megakaryocytic increase or normal, accompanied by maturation disorder. Platelet count \> 10 x10\^9 / L.
•4. Subjects with refractory ANCA-associated vasculitis: diagnosis of ANCA glomerulonephritis (GN) or vasculitis based on the 2013 American Chapel Hill Consensus Conference definition of AAV ;
•* Relapsed or refractory AAV requiring treatment with cyclophosphamide or rituximab
•* Newly diagnosed or recurrent AAV--, defined as accumulation of at least one major organ (e.g., kidney, lung, heart) requiring induction therapy with cyclophosphamide or rituximab;
•* Anti-PR3 or anti-MPO positive (current or history);
•5. Subjects with Refractory Dermatomyositis: Refractory MDA5-positive dermatomyositis is defined as active disease and meets the following conditions: adequate corticosteroid therapy (greater than two to four weeks of conventional corticosteroid therapy or intolerance to such therapy) and/or
+12 more criteria

Exclusion Criteria

•1. Patients with severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accident or CNS vasculitis requiring therapeutic intervention within 60 days after baseline;
•2. Dialysis patients;
•3. Pregnancy or lactation;
•4. Concomitant uncontrollable infection (e.g., sepsis, bacteremia, fungemia, uncontrolled pulmonary infection, etc.);
•5. Hepatitis B surface antigen (HBsAg) positive and hepatitis C (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, syphilis (TP) positive;
•6. Major surgery that was assessed as unsuitable by the investigator within 4 weeks before screening;
•7. Patient's heart meets any of the following:
•* Left ventricular ejection fraction (LVEF) ≤ 45%;
•* New York Heart Association (NYHA) Class III or IV congestive heart failure or active cardiac disease;
•* Serious arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia);
+9 more criteria

Locations (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Key Dates

Start Date

December 14, 2021

Primary Completion Date

December 13, 2025

Completion Date

December 13, 2025

Last Updated

February 10, 2025

Enrollment

ESTIMATED participants

Conditions

Lupus Erythematosus, Systemic

Interventions

single dose of CNCT19

BIOLOGICAL

Contacts

Ruijiao Huang

CONTACT

+86-010-65960098 huangruijiao@juventas.cn

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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: February 10, 2025Data 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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Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases

Inclusion Criteria

Exclusion Criteria

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)

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

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Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus

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