IM19 CAR-T Cell Therapy for IgA Nephropathy Patients and Membranous Nephropathy Patients (NCT06690359) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
IM19 CAR-T Cell Therapy for IgA Nephropathy Patients and Membranous Nephropathy Patients
12 participantsStarted 2024-12-13
Plain-language summary
IM19 CAR-T cell therapy for IgA nephropathy patients with urinary protein and renal dysfunction, as well as patients with intermediate to high-risk primary membranous nephropathy
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. IgA nephropathy diagnosed through renal biopsy
. When screening, urine protein should be ≥0.5g/gCr and 20mL/min/1.73m\^2≤eGFR\<60mL/min/1.73m\^2
. Age≥18years old
. Liver, kidney, heart, lung function, and coagulation function meet the following requirements:
.1 ALT and AST ≤ 2.5 × ULN,total bilirubin ≤ 1.5 × ULN (for subjects with Gilbert syndrome, ALT and AST ≤ 5 × ULN, total bilirubin ≤ 3 × ULN); 4.2 Left ventricular ejection fraction ≥ 50%; 4.3 International ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 4.4 Finger pulse oxygen saturation\>92% in non oxygen state;
. Women of childbearing age who have a negative blood pregnancy test before the start of the trial and agree to take effective contraceptive measures during the trial period until the last follow-up; Male participants with reproductive partners agree to take effective contraceptive measures during the trial period until the last follow-up;
. Doctors evaluate patients with the optimal benefit risk ratio
. Those who voluntarily participate in this experiment and sign the informed consent form
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
IgA nephropathy-Main safety endpoint（Adverse event incidence rate）
Timeframe: IM19 CAR-T cell reinfusion within 28 days
2
IgA primary efficacy endpoint（Urinary protein ratio）
Timeframe: 6 months after the first administration
. Kidney diseases other than IgA nephropathy, as well as primary and secondary nephrotic syndrome
. After examination by the researchers, it was determined that the subjects had diseases that were not suitable for participation in this study, such as life-threatening conditions (such as catastrophic antiphospholipid syndrome, acute severe renal failure, and acute severe central nervous system disease manifestations)
. Serious complications unrelated to IgA nephropathy
. Use or increase the dosage of corticosteroids, immunosuppressants, biologics (including but not limited to CD20 monoclonal antibodies, taceptil, etc.), anticoagulants (warfarin), and n-3 fatty acids (fish oil) for the drug treatment of IgA nephropathy within 3 months
. Uncontrollable hypertension or hyperglycemia
. Perform palatal tonsillectomy within 6 months
. Study subjects with a history of alcohol or drug abuse within the past 24 weeks
. Have undergone major surgery (including joint surgery) within 24 weeks prior to screening, or plan to undergo surgery within 24 weeks after enrollment in the study