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Lupus Erythematosus, SystemicEarly Phase 1NCT06316791

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

A Early Phase 1 study testing single dose of CNCT19 in people with Lupus Erythematosus, Systemic, run by Juventas Cell Therapy Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
single dose of CNCT19
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
14 Dec 2021to 13 Dec 2025
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The enrolled subjects or their legal representatives signed informed consent form;
  • age range: 18-70 years (including 18 and 70 years), male or female;
  • 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;
  • 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.
  • 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.
  • 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 ;
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  • 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);
  • 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
  • Use of ≥ 1 conventional immunosuppressive agent (eg, methotrexate, azathioprine, tacrolimus, cyclosporine, mycophenolate mofetil, IVIG, anti-TNF, or rituximab) at a reasonable dose and duration (greater than two to four weeks or intolerance to therapy);
  • Treatment with IVIG or cyclophosphamide for two to four weeks.
  • Women of childbearing potential must have a negative blood pregnancy test 7 days prior to trial conditioning therapy; any male and female patients of childbearing potential must agree to use an effective method of contraception throughout the study and for at least 1 year following reinfusion of CNCT19 CAR-T cells. Childbearing potential, in the judgment of the investigator, is biologically capable of bearing a living baby and sexually active. Female patients who were not of childbearing potential (ie, met at least 1 of the following criteria):
  • Hysterectomy or oophorectomy, or
  • Medically confirmed ovarian failure, or medically confirmed postmenopausal (cessation of menses for at least 12 consecutive months in the absence of pathological or physiological causes).
  • Adequate organ function according to the following criteria:
  • Aspartate aminotransferase (AST) ≤ 3 times of upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) ≤ 3 times ULN;
  • Total serum bilirubin ≤ 2 times ULN unless the patient has documented Gilbert's syndrome; patients with Gilbert's syndrome who have bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN may be included;
  • Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL/min (Cockcroft and Gault formula), Patients with lupus nephritis may relax the conditions appropriately according to the judgment of the investigator;
  • Must have minimal pulmonary reserve and oxygen saturation > 91% in a nonoxygenated state;
  • Lymphocyte count > 0.4 × 109/L.

Who cannot join

  • 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;
  • Dialysis patients;
  • Pregnancy or lactation;
  • Concomitant uncontrollable infection (e.g., sepsis, bacteremia, fungemia, uncontrolled pulmonary infection, etc.);
  • Hepatitis B surface antigen (HBsAg) positive and hepatitis C (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, syphilis (TP) positive;
  • Major surgery that was assessed as unsuitable by the investigator within 4 weeks before screening;
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  • 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);
  • QTc interval ≥ 450 ms for males and ≥ 470 ms for females (QTcB = QT/RR1/2);
  • Myocardial infarction, bypass surgery or stent surgery within 6 months prior to the study;
  • Other cardiac diseases that are not suitable for the study as judged by the investigator;
  • Received live vaccine within 6 weeks prior to screening.
  • Participation in other interventional clinical studies within 3 months prior to cell infusion, treatment with an active experimental drug, or intentional participation in another clinical trial or treatment outside of that specified by the protocol throughout the study period.
  • Patients with a history of epilepsy or other active central nervous system diseases;
  • Known hypersensitivity to the ingredients of the preparation used in the test;
  • Prior treatment with CAR-T cells.
  • Other conditions that the investigator considers inappropriate for participation in this clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ruijiao Huang contact

+86-010-65960098

huangruijiao@juventas.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Yi Zhang, Dr.

    Shengyun Liu, Dr.

    Recruiting

Other trials in China

About this study

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.

Being tested
single dose of CNCT19
Keywords
CNCT19, CD19-directed CAR-T cells
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • single dose of CNCT19Biological

    Autologous 2nd generation CD19-directed CAR-T cells, infusion intravenously.

Study groups in NCT06316791
Study groupRoleWhat they receive
Single dose of CNCT19ExperimentalA conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered before the investigational treatment, CNCT19.
Receives: Biological: single dose of CNCT19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Subjects Experiencing Treatment-Emergent Adverse Events（TEAE）

    Evaluate the type, frequency, severity of adverse events, and abnormal laboratory test values; Evaluate the frequency and severity of adverse events related to CNCT19.

    Measured: Up to 1 year after CNCT19 infusion

Secondary outcomes (7)

  1. Overall survival (OS)

    The time from the CNCT19 Cell Injection infusion to death due to any cause

    Measured: Up to 1 year after CNCT19 infusion

  2. SELENA-SLEDAI

    0 to 4 is basically no disease activity;5 to 9 is light activity;10 to 14 is moderate activity;≥15 is considered heavy activity.

    Measured: Up to 1 year after CNCT19 infusion

  3. The proportion of subjects who achieved glucocorticoids/immunosuppressant free and subjects who achieved low-dose glucocorticoids application during the main study period

    Measured: Up to 1 year after CNCT19 infusion

  4. To evaluate disease related biomarkers

    Levels of anti nuclear antibodies, anti double stranded DNA antibodies, anti small ribosomal nucleoprotein antibodies

    Measured: Up to 1 year after CNCT19 infusion

  5. To evaluate disease related biomarkers

    Levels of anti C1q antibodies

    Measured: Up to 1 year after CNCT19 infusion

  6. To evaluate disease related biomarkers

    Levels of anti cardiolipin antibodies (IgG, IgM, IgA)

    Measured: Up to 1 year after CNCT19 infusion

  7. To evaluate disease related biomarkers

    Levels of anti MDA5 antibody (melanoma differentiation associated gene 5) in serum

    Measured: Up to 1 year after CNCT19 infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study start14 Dec 2021
  3. Primary completion13 Dec 2025 (estimated)
  4. Study completion13 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06316791
Sponsor's protocol ID
HY001007
Status last verified
Feb 2025
First submitted
4 Mar 2024
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing single dose of CNCT19 in people with Lupus Erythematosus, Systemic, run by Juventas Cell Therapy Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ruijiao Huang (+86-010-65960098, huangruijiao@juventas.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects Experiencing Treatment-Emergent Adverse Events（TEAE） (time frame: Up to 1 year after CNCT19 infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06316791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.

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