IgA NephropathyEarly Phase 1NCT06690359

IM19 CAR-T Cell Therapy for IgA Nephropathy Patients and Membranous Nephropathy Patients

A Early Phase 1 study testing IM19 chimeric antigen receptor T cell injection in people with IgA Nephropathy and Membranous Nephropathy, run by Beijing Immunochina Medical Science & Technology Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: IgA Nephropathy, Membranous Nephropathy
What is being tested?: IM19 chimeric antigen receptor T cell injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: No sites listed yet
Study dates: 13 Dec 2024to 20 Dec 2026
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

IgA nephropathy
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:
4.1 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;

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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
Primary membranous nephropathy:
Diagnosis of primary membranous nephropathy through renal biopsy;
Primary membranous nephropathy at medium or high risk that has not improved after 6 months of treatment with CNI and rituximab:
2.1. Moderate risk assessment criteria 2.1.1. EGFR is normal, 24-hour urine protein is>4g, and conservative treatment with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers has been continuously used for 6 months or more before screening. The 24-hour urine protein has not decreased by less than 50% 2.1.2. PLA2R antibody<50RU/mL+ 2.1.3. Low molecular weight urinary protein 2.1.4. Selectivity index<0.15 2.1.5. Urinary immunoglobulin UIgG<250mg/day 2.2 High risk assessment criteria 2.2.1. eGFR<60ml/min/1.73m^2 2.2.2. 24-hour urine protein>4g and lasting>6 months 2.2.3. PLA2R antibody>150RU/mL+ 2.2.4. High molecular weight urinary protein 2.2.5. Urine immunoglobulin UigG>250mg/day 2.2.6. Selectivity index>0.20
Age ≥ 18 years old;
Liver, heart, lung function, and coagulation function meet the following requirements:
4.1. 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

Who cannot join

IgA nephropathy:
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

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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
Used other cell therapies
Have participated in or participated in other clinical trials within the past 3 months
Within 3 years or planning to undergo a kidney transplan
Active hepatitis B or hepatitis C virus, defined as: subjects with positive hepatitis B B virus surface antigen (HBsAg) and/or hepatitis B B core antibody (HBcAb, Hepatitis B core antibody) and HBV DNA titer in peripheral blood higher than the lower limit of detection; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA (HCV RNA); Syphilis infected individuals
Active EB virus and cytomegalovirus, defined as: subjects with positive or negative IgM antibodies in EB virus serum but EBV-DNA higher than normal values; Subjects with IgM antibody positive or IgM antibody negative but CMV-DNA higher than normal in the serum of cytomegalovirus (CMV)
Serious history of cardiovascular and cerebrovascular diseases, including but not limited to:
14.1. Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, third degree atrioventricular block, etc; 14.2. At rest, QT interval prolongation (QTc>450 milliseconds in males or>470 milliseconds in females); 14.3. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months prior to the first administration; 14.4. There is heart failure with NYHA functional class ≥ II in the United States;
History of symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months prior to the start of screening;
History of malignant tumors other than non melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) (unless in a disease-free state for at least 3 years)
Infections (fungal, bacterial, viral, or other) that require intravenous injection of antibiotics for control or are uncontrollable, such as simple urinary tract infections and bacterial pharyngitis, may be included if the researcher evaluates that they can be controlled through treatment
The researchers believe that it does not meet the criteria for joining this clinical trial
During pregnancy or lactation, it may be due to pregnancy or the male and female not agreeing to undergo contraception under the guidance of the researcher during the study period.
Primary membranous nephropathy:
Secondary membranous nephropathy;
Urinary protein decreased by more than 50% within the first 6 months of screening;
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 primary membranous nephropathy;
Uncontrollable hypertension or hyperglycemia;
The study subjects have 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;
Have used other cell therapies;
Have participated in or taken part in other clinical trials within the past 3 months;
Within 3 years or planning to undergo kidney transplantation;
Active hepatitis B or hepatitis C virus, defined as: subjects with positive hepatitis B B virus surface antigen (HBsAg) and/or hepatitis B B core antibody (HBcAb, Hepatitis B core antibody) and HBV DNA titer in peripheral blood higher than the lower limit of detection; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA (HCV RNA); Syphilis infected individuals;
Active EB virus and cytomegalovirus, defined as: subjects with positive or negative IgM antibodies in EB virus serum but EBV-DNA higher than normal values; Subjects with IgM antibody positive or IgM antibody negative but CMV-DNA higher than normal in the serum of cytomegalovirus (CMV);
History of serious cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, third degree atrioventricular block, etc; At rest, QT interval prolongation (QTc>450 milliseconds in males or>470 milliseconds in females); Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months prior to the first administration; There is heart failure with NYHA functional class ≥ II in the United States;
History of symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months prior to the start of screening;
History of malignant tumors other than non melanoma skin cancer or carcinoma in situ (such as cervix, bladder, breast) (unless in a disease-free state for at least 3 years);
Infections (fungal, bacterial, viral, or other) that require intravenous injection of antibiotics for control or are uncontrollable, such as simple urinary tract infections and bacterial pharyngitis, may be included if the researcher evaluates that they can be controlled through treatment;
The researcher believes that it does not meet the criteria for joining this clinical trial;
During pregnancy or lactation, it may be due to pregnancy or the male and female not agreeing to undergo contraception under the guidance of the researcher during the study period.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

yanping Ding, doctorate contact

01062886890

dingyanping@imunopharm.com

About this study

Official title: Evaluation of IM19 CAR-T Cell Therapy for IgA Nephropathy With Urinary Protein and Renal Dysfunction Safety and Efficacy of Patients With Primary Membranous Nephropathy and Those at Medium to High Risk Clinical Research

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

Read the detailed description

IgA nephropathy:

The investigators plan to recruit IgA nephropathy subjects with urinary protein and renal dysfunction who meet the inclusion and exclusion criteria. They will receive IM19 CAR-T cell infusion therapy at doses of 0.5 × 10 ^ 8 and 1 × 10 ^ 8 CAR-T cells, with 3 subjects enrolled at each dose. The investigators will evaluate the changes in urinary protein and eGFR relative to baseline values within 6 months of the first infusion, the rate of reaching the threshold, and the occurrence of adverse events related to IM19 CAR-T cell infusion within 28 days after the infusion.

And evaluate the long-term efficacy, namely the changes in urinary protein and eGFR relative to baseline values and the ratio of reaching threshold values after 360 days of cell transfusion. The retention amount and duration of IM19 CAR-T cells in the peripheral blood of subjects.

Primary membranous nephropathy:

The investigators plan to recruit primary membranous nephropathy subjects who meet the inclusion and exclusion criteria and receive IM19CAR-T cell infusion therapy at doses of 0.5 × 10 ^ 8 and 1 × 10 ^ 8 CAR-T cells. Three subjects will be enrolled at each dose to evaluate the changes and disappearance rate of PLA2Rab relative to baseline within 6 months after the first infusion, as well as the overall response rate (CR+PR), complete response rate, partial response rate, and incidence of adverse events related to IM19 CAR-T cell infusion within 28 days after IM19 CAR-T cell infusion.

And evaluate the long-term efficacy, that is, assess the rate of PLA2Rab changes and disappearance relative to baseline, overall response rate (CR+PR), complete response rate, and partial response rate of the subjects after 360 days of cell transfusion. The retention amount and duration of IM19 CAR-T cells in the peripheral blood of subjects.

Conditions: IgA Nephropathy, Membranous Nephropathy
Being tested: IM19 chimeric antigen receptor T cell injection
Medical subject headings: Glomerulonephritis, IGA, Glomerulonephritis, Membranous

What participants receive

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

IM19 chimeric antigen receptor T cell injectionCombination product
IgA nephropathy:
The investigators plan to recruit IgA nephropathy subjects with urinary protein and renal dysfunction who meet the inclusion and exclusion criteria. They will receive Beijing Zaimiao Biological IM19 CAR-T cell infusion therapy at doses of 0.5 × 10 ^ 8 and 1 × 10 ^ 8 CAR-T cells, with 3 subjects enrolled at each dose
Primary membranous nephropathy:
The investigators plan to recruit primary membranous nephropathy subjects who meet the inclusion and exclusion criteria and receive IM19CAR-T cell infusion therapy at doses of 0.5 × 10 ^ 8 and 1 × 10 ^ 8 CAR-T cells, with 3 subjects enrolled at each dose

Study groups in NCT06690359
Study group	Role	What they receive
IgA nephropathy subjects with urinary protein and renal insufficiency	Experimental	The study plans to recruit 6 patients with IgA nephropathy accompanied by urinary protein and renal dysfunction, including 3 patients receiving a dose of 0.5 × 10 ^ 8 CAR-T cells and 3 patients receiving a dose of 1 × 10 ^ 8 CAR-T cells Receives: Combination Product: IM19 chimeric antigen receptor T cell injection
Primary membranous nephropathy	Experimental	Recruiting 6 patients with medium to high-risk PMN, including 3 patients receiving 0.5 × 10 ^ 8 CAR-T cell dose and 3 patients receiving 1 × 10 ^ 8 CAR-T cell dose, for corresponding doses of IM19 CAR-T cell infusion therapy Receives: Combination Product: IM19 chimeric antigen receptor T cell injection

What is being measured

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

IgA nephropathy-Main safety endpoint（Adverse event incidence rate）
The incidence of adverse events related to IM19 CAR-T cell reinfusion within 28 days after IM19 CAR-T cell reinfusion, as well as clinically significant laboratory test results.
Measured: IM19 CAR-T cell reinfusion within 28 days
IgA primary efficacy endpoint（Urinary protein ratio）
Changes in urinary protein levels (1 day, 14 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months after initial administration) relative to baseline values and the rate of reaching the threshold
Measured: 6 months after the first administration
PMN primary safety endpoint（Adverse event incidence rate）
The incidence of adverse events related to IM19 CAR-T cell reinfusion within 28 days after IM19 CAR-T cell reinfusion, as well as clinically significant laboratory test results.
Measured: IM19 CAR-T cell reinfusion within 28 days
PMN primary efficacy endpoint（Relief rate）
Evaluate the overall response rate (CR+PR), complete response rate, and partial response rate of the subjects 6 months after the first infusion.
Complete remission criteria: Urinary protein ≤ 0.3g and serum albumin>3.5g/dl. Partial relief criteria: Urinary protein reduction>50% compared to baseline and final 0.3g<urinary protein ≤ 3.5g.
Measured: 6 months after the first administration

Secondary outcomes (3)

IgA secondary endpoint（EGFR ratio）
The ratio of eGFR levels reaching the threshold after IM19CAR-T cell reinfusion
Measured: 360 days after IM19 CAR-T cell reinfusion
IgA secondary endpoint（Urinary protein ratio）
The ratio of urinary protein levels reaching the threshold after IM19CAR-T cell reinfusion
Measured: 360 days after IM19 CAR-T cell reinfusion
PMN secondary endpoint（Relief rate）
Evaluate the rate of relative baseline changes and disappearance of PLA2Rab, overall response rate (CR+PR), complete response rate, and partial response rate in subjects after 360 days of cell transfusion
Measured: 360 days after IM19 CAR-T cell reinfusion

Timeline

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

13 Dec 202420 Dec 2026

First posted15 Nov 2024
Study start13 Dec 2024 (estimated)
Primary completion4 Aug 2025 (estimated)
Study completion20 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for IgA NephropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 12 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06690359
Sponsor's protocol ID: ZMA02
Status last verified: Nov 2024
First submitted: 5 Nov 2024
Last updated: 26 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

yanping Ding, doctorate

01062886890

dingyanping@imunopharm.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)

All IgA Nephropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of IM19 CAR-T Cell Therapy for IgA Nephropathy With Urinary Protein and Renal Dysfunction Safety and Efficacy of Patients With Primary Membranous Nephropathy and Those at Medium to High Risk Clinical Research
ClinicalTrials.gov ID: NCT06690359
Acronym / sponsor ID: ZMA02
Conditions: IgA Nephropathy, Membranous Nephropathy
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 12 participants (estimated)
Lead sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 13 Dec 2024 (estimated)
Primary completion: 4 Aug 2025 (estimated)
Study completion: 20 Dec 2026 (estimated)
First posted: 15 Nov 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

IgA nephropathy:

Primary membranous nephropathy:

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IgA nephropathy subjects with urinary protein and renal insufficiency	Experimental	Combination Product: IM19 chimeric antigen receptor T cell injectionThe study plans to recruit 6 patients with IgA nephropathy accompanied by urinary protein and renal dysfunction, including 3 patients receiving a dose of 0.5 × 10 ^ 8 CAR-T cells and 3 patients receiving a dose of 1 × 10 ^ 8 CAR-T cells
Primary membranous nephropathy	Experimental	Combination Product: IM19 chimeric antigen receptor T cell injectionRecruiting 6 patients with medium to high-risk PMN, including 3 patients receiving 0.5 × 10 ^ 8 CAR-T cell dose and 3 patients receiving 1 × 10 ^ 8 CAR-T cell dose, for corresponding doses of IM19 CAR-T cell infusion therapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

IgA nephropathy
4.1 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;
Primary membranous nephropathy:
2.1. Moderate risk assessment criteria 2.1.1. EGFR is normal, 24-hour urine protein is>4g, and conservative treatment with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers has been continuously used for 6 months or more before screening. The 24-hour urine protein has not decreased by less than 50% 2.1.2. PLA2R antibody<50RU/mL+ 2.1.3. Low molecular weight urinary protein 2.1.4. Selectivity index<0.15 2.1.5. Urinary immunoglobulin UIgG<250mg/day 2.2 High risk assessment criteria 2.2.1. eGFR<60ml/min/1.73m^2 2.2.2. 24-hour urine protein>4g and lasting>6 months 2.2.3. PLA2R antibody>150RU/mL+ 2.2.4. High molecular weight urinary protein 2.2.5. Urine immunoglobulin UigG>250mg/day 2.2.6. Selectivity index>0.20
4.1. 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

Key exclusion criteria (40 listed)

IgA nephropathy:
14.1. Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, third degree atrioventricular block, etc; 14.2. At rest, QT interval prolongation (QTc>450 milliseconds in males or>470 milliseconds in females); 14.3. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months prior to the first administration; 14.4. There is heart failure with NYHA functional class ≥ II in the United States;
Primary membranous nephropathy:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IM19 chimeric antigen receptor T cell injectionIgA nephropathy: The investigators plan to recruit IgA nephropathy subjects with urinary protein and renal dysfunction who meet the inclusion and exclusion criteria. They will receive Beijing Zaimiao Biological IM19 CAR-T cell infusion therapy at doses of 0.5 × 10 ^ 8 and 1 × 10 ^ 8 CAR-T cells, with 3 subjects enrolled at each dose Primary membranous nephropathy: The investigators plan to recruit primary membranous nephropathy subjects who meet the inclusion and exclusion criteria and receive IM19CAR-T cell infusion therapy at doses of 0.5 × 10 ^ 8 and 1 × 10 ^ 8 CAR-T cells, with 3 subjects enrolled at each dose	Combination product	IgA nephropathy subjects with urinary protein and renal insufficiency, Primary membranous nephropathy

Primary outcome

IgA nephropathy-Main safety endpoint（Adverse event incidence rate）
Time frame: IM19 CAR-T cell reinfusion within 28 days
The incidence of adverse events related to IM19 CAR-T cell reinfusion within 28 days after IM19 CAR-T cell reinfusion, as well as clinically significant laboratory test results.
IgA primary efficacy endpoint（Urinary protein ratio）
Time frame: 6 months after the first administration
Changes in urinary protein levels (1 day, 14 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months after initial administration) relative to baseline values and the rate of reaching the threshold
PMN primary safety endpoint（Adverse event incidence rate）
Time frame: IM19 CAR-T cell reinfusion within 28 days
The incidence of adverse events related to IM19 CAR-T cell reinfusion within 28 days after IM19 CAR-T cell reinfusion, as well as clinically significant laboratory test results.
PMN primary efficacy endpoint（Relief rate）
Time frame: 6 months after the first administration
Evaluate the overall response rate (CR+PR), complete response rate, and partial response rate of the subjects 6 months after the first infusion. Complete remission criteria: Urinary protein ≤ 0.3g and serum albumin>3.5g/dl. Partial relief criteria: Urinary protein reduction>50% compared to baseline and final 0.3g<urinary protein ≤ 3.5g.

3 secondary outcomes

IgA secondary endpoint（EGFR ratio）
Time frame: 360 days after IM19 CAR-T cell reinfusion
IgA secondary endpoint（Urinary protein ratio）
Time frame: 360 days after IM19 CAR-T cell reinfusion
PMN secondary endpoint（Relief rate）
Time frame: 360 days after IM19 CAR-T cell reinfusion

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
Individual participant dataSharing planned: No

Related trials for IgA Nephropathy

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

yanping Ding, doctorate contact

01062886890

dingyanping@imunopharm.com

xiangmei Chen, doctorate principal investigator

Chinese PLA General Hospital

Questions about this trial

What is this clinical trial studying?

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 19 inclusion and 40 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: opening soon, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

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 yanping Ding, doctorate (01062886890, dingyanping@imunopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IgA nephropathy-Main safety endpoint（Adverse event incidence rate） (time frame: IM19 CAR-T cell reinfusion within 28 days). The study lists 4 primary outcomes in all. 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 NCT06690359.

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 26 Nov 2024.