BridgeMD
New treatment option for Inflammatory Myopathy
Official title BCMA-CD19 cCAR-T for the Treatment of Refractory Inflammatory Myopathy
ClinicalTrials.gov ID: NCT07715136
What this study is testing
What is ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR-T?
ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR-T is an investigational medicine, being studied as a potential treatment for inflammatory myopathy.
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 single-arm, open-label, phase I trial evaluates the safety and tolerability of ICG318 CAR-T (BCMA-CD19-IL-15/IL15sushi cCAR T cells) in patients with refractory Idiopathic inflammatory myopathy (IIM).
- 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 18 to 60
You may be able to join if
- Age 18-60 (age ≥18 years at first symptom onset), gender not limited;
- The diagnosis meets the criteria for IIM according to the 2017 EULAR/ACR criteria and is confirmed to be of the following subtype: a...
- Refractory IIM: At least one round of high-dose corticosteroid therapy and/or intravenous immunoglobulin, and at least two immunosuppressants...
- At the time of enrollment, participants must be receiving background medication at a stable dose, defined as: receiving background therapy with one...
- Severity of enrollment met the following criteria:
You likely can't join if
- During the screening period, individuals with active viral, bacterial, or other infections requiring systemic treatment are excluded.
- The presence of a serious, poorly controlled comorbidity that the investigator considers clinically significant, such as (but not limited to)...
- Patients with severe organ dysfunction:
- The estimated glomerular filtration rate (eGFR) using the MDRD formula is \<40 ml/min/1.73m² ; [eGFR = 186 × (age) - 0.203 × SCr - 1.154 (mg/dl), for...
- Study participants with total bilirubin \>1.5 times the upper limit of normal (no specific restrictions are made for liver enzymes because...
- Cardiovascular: Assessed by echocardiography (ECHO) or cardiac radionuclide angiography (MUGA), with a left ventricular ejection fraction (LVEF)...
See the full eligibility criteria
- Age 18-60 (age ≥18 years at first symptom onset), gender not limited;
- The diagnosis meets the criteria for IIM according to the 2017 EULAR/ACR criteria and is confirmed to be of the following subtype: a. Dermatomyositis: i. Presence of Gottron's rash or sunspot rash; ii. At least one...
- Refractory IIM: At least one round of high-dose corticosteroid therapy and/or intravenous immunoglobulin, and at least two immunosuppressants (including but not limited to cyclophosphamide, mycophenolate mofetil...
- At the time of enrollment, participants must be receiving background medication at a stable dose, defined as: receiving background therapy with one oral glucocorticoid and/or one immunosuppressant at a stable dose for ≥...
- Severity of enrollment met the following criteria:
- MMT-8 score ≤141 (out of 150);
- Students must meet at least one of the following CSM numerical scale criteria based on abnormal visual analog scale (VAS) scores: Overall activity assessed by study participants ≥2; overall disease activity assessed by...
- At least one muscle enzyme level \>1.5 times ULN;
- Through examinations such as tumor markers, lung and abdominal CT scans, thyroid ultrasound, breast ultrasound, and gastroscopy and colonoscopy, possible potential tumors have been ruled out.
- During the screening period, individuals with active viral, bacterial, or other infections requiring systemic treatment are excluded.
- The presence of a serious, poorly controlled comorbidity that the investigator considers clinically significant, such as (but not limited to) neurological, cardiovascular, renal, hepatic, endocrine, or gastrointestinal...
- Patients with severe organ dysfunction:
- The estimated glomerular filtration rate (eGFR) using the MDRD formula is \<40 ml/min/1.73m² ; [eGFR = 186 × (age) - 0.203 × SCr - 1.154 (mg/dl), for women, the result is multiplied by 0.742].
- Study participants with total bilirubin \>1.5 times the upper limit of normal (no specific restrictions are made for liver enzymes because inflammatory myopathy can cause elevated ALT/AST).
- Cardiovascular: Assessed by echocardiography (ECHO) or cardiac radionuclide angiography (MUGA), with a left ventricular ejection fraction (LVEF) \<50% and oxygen saturation \<94%. Alternatively, patients may have poorly...
- Bone marrow function: Absolute neutrophil count (ANC) \<1×10⁹/L; Absolute lymphocyte count (ALC) \<0.1×10⁹/L; Platelet count \<50×10⁹/L; Hemoglobin \<8.0 g/dL;
- Research participants who have a history of or current malignancy;
- Infectious diseases: Research participants with active hepatitis B (defined as positive hepatitis B surface antigen or positive hepatitis B core antibody, with hepatitis B virus DNA detection value \>1000 copies/mL) or...
- Central nervous system diseases, including cerebrovascular diseases, epilepsy, etc.;
- Allergies to components of treatment or pre-conditioning.
- Those with elective surgery planned during the study period;
- Those who do not wish to take necessary contraceptive measures during the research period;
- Any other situation that researchers deem unsuitable for participation in the study including poor compliance and being involved in another clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, 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, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, 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.