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New treatment option for Juvenile Dermatomyositis
Official title Clinical Trial of CD19-targeted CAR-T Therapy for Refractory Juvenile Dermatomyositis
ClinicalTrials.gov ID: NCT06569472
What this study is testing
What is CD19-targetd CAR-T?
CD19-targetd CAR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for juvenile dermatomyositis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase I clinical trial to evaluate the efficacy and safety of CD19-targeted CAR-T in the treatment of refractory juvenile dermatomyositis (RJDM).The experiment was divided into two phases: dose exploration (Part A) and dose extension (Part B).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 17
You may be able to join if
- Age: ≥5 years and \<17 years old
- To meet the diagnostic criteria of JDM, four or five of the following criteria must be met:① symmetrical proximal muscle weakness; ②Characteristic...
- The classification criteria of RJDM must meet ① and any of the criteria②-④: ① Patients who are intolerant or unresponsive to glucocorticoids and at...
- myositis specific antibody positive, defined as MDA-5, NXP2, TIF-1γ, Ro-52 and any other positive;
- If the patient has SRP or HMGCR antibody positive immune-mediated necrotizing myopathy equivalent to RJDM, the of (2) - (4) can be met.
You likely can't join if
- Had previously received CAR T cell therapy;
- Have other autoimmune or rheumatic diseases other than JDM;
- primary immunodeficiency or severe secondary immunodeficiency that has not been corrected;
- accompanied by serious infectious diseases, including but not limited to active tuberculosis, latent tuberculosis infection, active viral hepatitis...
- Evidence of active malignant disease or diagnosis of malignant tumor (including hematological malignancies and solid tumors, except resected and...
- Congenital heart disease or history of acute myocardial infarction within 6 months before screening, or severe arrhythmias (including multi-source...
See the full eligibility criteria
- Age: ≥5 years and \<17 years old
- To meet the diagnostic criteria of JDM, four or five of the following criteria must be met:① symmetrical proximal muscle weakness; ②Characteristic skin changes, including positive dermatitis (purplish red rash on upper...
- The classification criteria of RJDM must meet ① and any of the criteria②-④: ① Patients who are intolerant or unresponsive to glucocorticoids and at least 2 immunosuppressants, adequate hormone therapy and duration of at...
- myositis specific antibody positive, defined as MDA-5, NXP2, TIF-1γ, Ro-52 and any other positive;
- If the patient has SRP or HMGCR antibody positive immune-mediated necrotizing myopathy equivalent to RJDM, the of (2) - (4) can be met.
- The functions of important organs are basically normal: ① Cardiac function: left ventricular ejection fraction (LVEF) ≥55%, no obvious abnormality in electrocardiogram; ② Renal function: eGFR≥30ML/min/1.73m2; ③ Liver...
- Have the criteria for simple or intravenous blood collection, and no other contraindications for cell collection;
- The subject of childbearing age has a negative urine pregnancy test result and agrees to take effective contraceptive measures during the test period until 1 year after the infusion;
- The patient or his/her guardian agrees to participate in this clinical trial and signs an informed consent indicating that he/she understands the purpose and procedure of this clinical trial and is willing to...
- Had previously received CAR T cell therapy;
- Have other autoimmune or rheumatic diseases other than JDM;
- primary immunodeficiency or severe secondary immunodeficiency that has not been corrected;
- accompanied by serious infectious diseases, including but not limited to active tuberculosis, latent tuberculosis infection, active viral hepatitis, etc.;
- Evidence of active malignant disease or diagnosis of malignant tumor (including hematological malignancies and solid tumors, except resected and cured skin basal cell carcinoma)
- Congenital heart disease or history of acute myocardial infarction within 6 months before screening, or severe arrhythmias (including multi-source frequent supraventricular tachycardia, ventricular tachycardia, etc.)...
- suffering from other diseases that require long-term use of glucocorticoids or immunosuppressants;
- There is an active or uncontrollable infection that requires systemic treatment within 1 week prior to screening;
- Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months before screening; Acute graft-versus-host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody...
- Had received live vaccine within 4 weeks prior to screening;
- Positive blood pregnancy test;
- Patients with known malignant diseases such as tumors before screening;
- Patients who had participated in other clinical trials within 3 months prior to enrollment;
- Situations in which other investigators consider it inappropriate to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.