IgA Nephropathy (IgAN)Early Phase 1NCT06926985
An Exploratory Clinical Study of Anti-CD19/BCMA Chimeric Antigen Receptor NK Cell Injection in the Treatment of IgA Nephropathy
A Early Phase 1 study testing anti-CD19/BCMA CAR NK cells in people with IgA Nephropathy (IgAN), run by Jieyang People's Hospital at 1 site in China.
Trial summary
A single arm, open-label pilot study is designed to evaluate the safety and effectiveness of anti-CD19/BCMA CAR NK cells (KN5601) in patients with IgA nephropathy Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IgA Nephropathy (IgAN)
- What is being tested?
- anti-CD19/BCMA CAR NK cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to 30 Apr 2027
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥ 18 years old and ≤ 70 years old, male or female;
- IgA nephropathy confirmed by pathological biopsy of renal biopsy;
- All females of childbearing potential must use effective contraception during treatment and for 90 days after the last dose of treatment. In addition, subjects must not donate eggs during the study and for at least 90 days after the last dose of treatment;
- Urine total protein/urine creatinine ratio (UPCR) ≥ 500 mg/g and estimated glomerular filtration rate (eGFR) > 20 ml/min/1.73m2 during the screening period
Who cannot join
- Subjects with IgA nephropathy with rapidly progressive renal function, pathological manifestations include extensive crescent formation and necrotic vascular lesions in the glomeruli;
- Secondary IgA nephropathy;
- Subjects do not take medication regularly or stop taking medication during treatment;
- Individuals with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions;
- Subjects with active infection (except simple urinary tract infection and bacterial pharyngitis), or currently receiving intravenous antibiotic treatment, or subjects who have received intravenous antibiotic treatment within 1 week before KN5601 infusion;
- Subjects with acquired and congenital immunodeficiency diseases;
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- Subjects with grade III or IV heart failure (NYHA classification);
- History of epilepsy or other central nervous system (CNS) diseases;
- History of severe herpes infection, such as herpes encephalitis, ocular herpes, or disseminated herpes; signs of herpes or varicella-zoster virus infection (especially chickenpox, herpes zoster) within 12 weeks prior to screening;
- History of other primary malignant tumors except:
- Cured non-melanoma skin cancer by surgical excision, for example basal cell carcinoma (BCC) ;
- Cured primary malignant tumors, such as cervical cancer, superficial bladder cancer, breast cancer
- Has a history of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urinary, pulmonary, neurological, dermatologic, psychiatric, and renal disease or other significant disease that precludes KN5601 administration (as determined by the investigator), except IgA nephropathy;
- Females who are pregnant, lactating, or planning a pregnancy within six months;
- Subjects who have received other clinical trial treatment within 3 months;
- Subjects who have received B cell-targeted drug therapy within 1 months before enrollment;
- Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria;
- Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Clinical Study of the Safety and Efficacy of Anti-CD19/BCMA Chimeric Antigen Receptor NK Cell Injection in the Treatment of IgA Nephropathy
A single arm, open-label pilot study is designed to evaluate the safety and effectiveness of anti-CD19/BCMA CAR NK cells (KN5601) in patients with IgA nephropathy
- Conditions
- IgA Nephropathy (IgAN)
- Being tested
- anti-CD19/BCMA CAR NK cells
- Keywords
- IgA Nephropathy, CD19 BCMA CAR NK, SLE
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19/BCMA CAR NK cellsBiological
Patients will receive Fludarabine and Cyclophosphamide on day -5, -4, and -3. Multiple doses of anti-CD19/ BCMA CAR NK cells will infused using the dose-escalation strategy.
| Study group | Role | What they receive |
|---|---|---|
| anti-CD19 BCMA CAR NK cells | Experimental | Not described Receives: Biological: anti-CD19/BCMA CAR NK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicity (DLT)
To characterize the safety of CD19 CAR NK Cells (KN5601) for IgA Nephropathy
Measured: up to 52 weeks after infusion
Incidence of Treatment Emergent Adverse Events (TEAEs)
To characterize the safety of CD19 CAR NK Cells (KN5601) for IgA Nephropathy
Measured: up to 52 weeks after infusion
Secondary outcomes (2)
The complete response rate
To characterize the efficacy of CD19 CAR NK Cell (KN5601) for for IgA Nephropathy
Measured: 52 weeks after infusion
The partial response rate
To characterize the efficacy of CD19 CAR NK Cell (KN5601) for for IgA Nephropathy
Measured: 48 weeks after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start30 Jul 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Why it stopped: Due to limitation of production capacity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jieyang People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qinghua Liu, Jieyang People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926985
- Sponsor's protocol ID
- 2025002
- Status last verified
- Jul 2025
- First submitted
- 8 Apr 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of the Safety and Efficacy of Anti-CD19/BCMA Chimeric Antigen Receptor NK Cell Injection in the Treatment of IgA Nephropathy
- ClinicalTrials.gov ID
- NCT06926985
- Acronym / sponsor ID
- 2025002
- Conditions
- IgA Nephropathy (IgAN)
- Keywords
- IgA Nephropathy, CD19 BCMA CAR NK, SLE
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to limitation of production capacity
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jieyang People's HospitalUniversity, hospital or other
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 15 Apr 2025 (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.
A single arm, open-label pilot study is designed to evaluate the safety and effectiveness of anti-CD19/BCMA CAR NK cells (KN5601) in patients with IgA nephropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-CD19 BCMA CAR NK cells | Experimental | Biological: anti-CD19/BCMA CAR NK cells |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: ≥ 18 years old and ≤ 70 years old, male or female;
- IgA nephropathy confirmed by pathological biopsy of renal biopsy;
- All females of childbearing potential must use effective contraception during treatment and for 90 days after the last dose of treatment. In addition, subjects must not donate eggs during the study and for at least 90 days after the last dose of treatment;
- Urine total protein/urine creatinine ratio (UPCR) ≥ 500 mg/g and estimated glomerular filtration rate (eGFR) > 20 ml/min/1.73m2 during the screening period
Key exclusion criteria (18 listed)
- Subjects with IgA nephropathy with rapidly progressive renal function, pathological manifestations include extensive crescent formation and necrotic vascular lesions in the glomeruli;
- Secondary IgA nephropathy;
- Subjects do not take medication regularly or stop taking medication during treatment;
- Individuals with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions;
- Subjects with active infection (except simple urinary tract infection and bacterial pharyngitis), or currently receiving intravenous antibiotic treatment, or subjects who have received intravenous antibiotic treatment within 1 week before KN5601 infusion;
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 |
|---|---|---|
| anti-CD19/BCMA CAR NK cellsPatients will receive Fludarabine and Cyclophosphamide on day -5, -4, and -3. Multiple doses of anti-CD19/ BCMA CAR NK cells will infused using the dose-escalation strategy. | Biological | anti-CD19 BCMA CAR NK cells |
Primary outcome
Incidence of Dose-Limiting Toxicity (DLT)
Time frame: up to 52 weeks after infusion
To characterize the safety of CD19 CAR NK Cells (KN5601) for IgA Nephropathy
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: up to 52 weeks after infusion
To characterize the safety of CD19 CAR NK Cells (KN5601) for IgA Nephropathy
2 secondary outcomes
The complete response rate
Time frame: 52 weeks after infusion
The partial response rate
Time frame: 48 weeks after infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing anti-CD19/BCMA CAR NK cells in people with IgA Nephropathy (IgAN), run by Jieyang People's Hospital at 1 site in China.
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 4 inclusion and 18 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: withdrawn, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicity (DLT) (time frame: up to 52 weeks after infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jul 2025.