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 range18 Years

SexALL

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

✕. 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

What they're measuring

IgA nephropathy-Main safety endpoint（Adverse event incidence rate）

Timeframe: IM19 CAR-T cell reinfusion within 28 days

IgA primary efficacy endpoint（Urinary protein ratio）

Timeframe: 6 months after the first administration

PMN primary safety endpoint（Adverse event incidence rate）

Timeframe: IM19 CAR-T cell reinfusion within 28 days

PMN primary efficacy endpoint（Relief rate）

Timeframe: 6 months after the first administration

Trial details

NCT IDNCT06690359

SponsorBeijing Immunochina Medical Science & Technology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-04

Contact for this trial

yanping Ding, doctorate

01062886890 dingyanping@imunopharm.com

View on ClinicalTrials.gov More IgA Nephropathy trials

Who can participate

Age range18 Years

SexALL

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

✕. 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

What they're measuring

IgA nephropathy-Main safety endpoint（Adverse event incidence rate）

Timeframe: IM19 CAR-T cell reinfusion within 28 days

IgA primary efficacy endpoint（Urinary protein ratio）

Timeframe: 6 months after the first administration

PMN primary safety endpoint（Adverse event incidence rate）

Timeframe: IM19 CAR-T cell reinfusion within 28 days

PMN primary efficacy endpoint（Relief rate）

Timeframe: 6 months after the first administration