Lupus NephritisPhase 1/2CRC01-02NCT07364396
Efficacy and Safety of CRC01 in Participants With Severe, Refractory Systemic Lupus Erythematosus
A Phase 1/2 study testing CRC01 in people with Lupus Nephritis and Lupus Nephritis (LN), run by Curocell Inc..
Trial summary
The purpose of this clinical trial is to evaluate the safety and efficacy of CRC01, an investigational autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, in people with lupus nephritis (LN), a serious kidney complication of systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lupus Nephritis, Lupus Nephritis (LN), SLE
- What is being tested?
- CRC01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Jun 2030
- Phase
- Phase 1/2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 years or older, voluntarily provides written informed consent.
- Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria.
- Positive antinuclear antibody (ANA) at screening (titer ≥1:80).
- Diagnosis of lupus nephritis Class III or IV (with or without concurrent Class V), confirmed by kidney biopsy within 1 year prior to screening based on ISN/RPS 2018 criteria.
- Inadequate response to, or intolerance of, at least two or more standard therapies for 6 months or longer (cyclophosphamide, mycophenolate mofetil, azathioprine, tacrolimus, rituximab, belimumab).
- Proteinuria at screening with urine protein-to-creatinine ratio (UPCR) >1.5.
Show all 22Show fewer
- Adequate laboratory values at screening: Hemoglobin >8.0 g/dL; ANC >1,000/μL; Platelets ≥50,000/μL; Total bilirubin ≤2.0 × ULN; AST and ALT ≤3 × ULN; eGFR ≥30 mL/min/1.73 m².
- Hemodynamically stable, no pericardial effusion, and LVEF ≥50% by echocardiogram at screening.
- FEV1/FVC ≥70% at screening.
- Willing and able to comply with study visits, procedures, and requirements.
- Women of childbearing potential and men must agree to use effective contraception for at least 1 year after CRC01 infusion until PCR testing confirms clearance of CRC01.
- No clinically significant worsening of organ function after screening.
- If any of the following adverse events related to lymphodepleting chemotherapy exceed Grade 1 or worsen compared with screening, CRC01 infusion must be delayed:
- Requirement for supplemental oxygen
- New arrhythmia symptoms or clinically significant changes in cardiac function compared with screening
- Hypotension requiring treatment
- Active infection within 72 hours prior to the planned CRC01 infusion
- If bacterial, viral, or fungal infection is documented, improvement of symptoms must be documented before infusion.
- Women of childbearing potential must have a negative urine pregnancy test prior to infusion.
- If CRC01 infusion is delayed for more than 2 weeks after lymphodepleting chemotherapy, administration may proceed only with approval from the sponsor's medical monitor.
- No receipt of therapeutic doses of systemic corticosteroids or immunosuppressive agents within 7 days prior to CRC01 infusion. (Prednisone ≤7.5 mg/day or equivalent is permitted.)
- No receipt of antibody-based therapies (e.g., belimumab, rituximab, anifrolumab) within 4 weeks prior to CRC01 infusion.
Who cannot join
- Current or anticipated requirement for renal dialysis during the study.
- History of kidney transplantation or planned transplantation during the study.
- History of severe CNS lupus or currently active severe CNS lupus.
- Prior CAR-T cell therapy.
- History of malignancy except for: basal or squamous cell carcinoma of skin treated and disease-free ≥3 years; in-situ carcinoma of cervix or breast treated and disease-free ≥3 years; superficial bladder cancer treated and disease-free ≥3 years; completely resected primary malignancy in complete remission ≥5 years.
- Unstable angina and/or myocardial infarction within 1 year prior to screening.
Show all 20Show fewer
- Congestive heart failure of NYHA Class III or IV within 1 year prior to screening.
- Thromboembolism, pulmonary embolism, or clinically significant bleeding diathesis within 6 months prior to screening.
- Hypoxemia, clinically significant pleural effusion, or abnormal ECG findings within 6 months prior to screening.
- Stroke (ischemic or hemorrhagic) within 6 months prior to screening.
- Positive HBsAg; positive anti-HCV (eligible if HCV RNA negative); known HIV infection; or active neurological autoimmune/inflammatory diseases (e.g., Guillain-Barré syndrome, ALS).
- Recurrent or symptomatic ventricular tachycardia, or atrial fibrillation with rapid ventricular response despite therapy within 3 months prior to screening.
- Severe or uncontrolled active infection requiring systemic therapy at screening.
- Rapidly progressive disease or otherwise unsuitable for study participation, per investigator judgment.
- Pregnant or breastfeeding women.
- Known hypersensitivity to investigational product components.
- Participation in another investigational study within 4 weeks prior to screening.
- Receipt of systemic corticosteroids at therapeutic doses within 7 days prior to leukapheresis (≤7.5 mg/day prednisone equivalent is permitted).
- Receipt of immunosuppressive agents within 7 days prior to leukapheresis.
- Receipt of antibody-based therapies (e.g., belimumab, rituximab, anifrolumab) within 4 weeks prior to leukapheresis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label, Multi-center, Single-arm Phase 1/2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus
The purpose of this clinical trial is to evaluate the safety and efficacy of CRC01, an investigational autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, in people with lupus nephritis (LN), a serious kidney complication of systemic lupus erythematosus (SLE).
The main objectives of the study are:
Read more
- To determine whether CRC01 infusion can improve kidney outcomes and reduce disease activity in participants with lupus nephritis.
- To assess the safety profile, including potential risks such as cytokine release syndrome (CRS) and neurotoxicity.
Study Design This is a single-arm, open-label, multi-center, Phase 1/2 study. All enrolled participants will receive CRC01 after screening and baseline assessments.
Study Procedures
Participants will:
- Undergo eligibility screening, including blood tests, urine tests, and disease activity assessments.
- Provide autologous T lymphocytes through a procedure called leukapheresis.
- Receive a lymphodepleting pre-conditioning regimen (short course of chemotherapy).
- Receive a single intravenous infusion of CRC01 cells.
- Be hospitalized for close monitoring to detect and manage early adverse events such as CRS or neurotoxicity.
- Return for scheduled follow-up assessments through Week 52 (12 months) post-infusion to evaluate safety and treatment response.
Key Outcomes
Researchers will measure:
- Changes in proteinuria and kidney function.
- Changes in disease activity scores.
- Incidence and severity of adverse events.
- Conditions
- Lupus Nephritis, Lupus Nephritis (LN), SLE, SLE (Systemic Lupus)
- Being tested
- CRC01
- Medical subject headings
- Lupus Nephritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRC01Biological
Autologous T lymphocytes genetically modified to express anti-CD19 chimeric antigen receptor (CAR). Administered as a single intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| CRC01 | Experimental | Participants with lupus nephritis will receive a single intravenous infusion of CRC01 (autologous anti-CD19 CAR-T cells) following lymphodepleting pre-conditioning chemotherapy. Receives: Biological: CRC01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Study: To evaluate the tolerability of CRC01 in patients with severe refractory autoimmune disease (systemic lupus erythematosus), and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
Safety and tolerability will be assessed by:
- Number of participants with dose-limiting toxicities (DLTs) within 28 days after CRC01 infusion, as assessed by CTCAE v5.0 and ASTCT consensus criteria.
Measured: 28 day
Phase 1 Study: To evaluate the tolerability of CRC01 in patients with severe refractory autoimmune disease (systemic lupus erythematosus), and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
Safety and tolerability will be assessed by:
- Determination of the maximum tolerated dose (MTD) defined as the highest dose level at which ≤1 of 6 participants experience a DLT.
Measured: 28 day
Phase 1 Study: To evaluate the tolerability of CRC01 in patients with severe refractory autoimmune disease (systemic lupus erythematosus), and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
Safety and tolerability will be assessed by:
- Determination of the recommended Phase 2 dose (RP2D) based on incidence of DLTs, safety profile, and investigator/sponsor assessment.
Measured: 28 day
Phase 2 Study: To evaluate the efficacy of CRC01 by assessing Complete Renal Response (CRR)
Complete Renal Response (CRR): Defined as meeting all of the following criteria:
- 24-hour urine protein ≤0.5 g, or urine protein-to-creatinine ratio (UPCR) ≤0.5.
If a 24-hour urine collection is available and meets adequacy criteria, 24-hour urine protein assessment takes precedence. If the 24-hour urine collection is inadequate or not performed, UPCR will be used for evaluation.
Measured: 24 weeks
Phase 2 Study: To evaluate the efficacy of CRC01 by assessing Complete Renal Response (CRR)
Complete Renal Response (CRR): Defined as meeting all of the following criteria:
- eGFR ≥60 mL/min/1.73m², or a decrease in eGFR ≤20% compared with the pre-flare value.
Measured: 24 weeks
Phase 2 Study: To evaluate the efficacy of CRC01 by assessing Complete Renal Response (CRR)
Complete Renal Response (CRR): Defined as meeting all of the following criteria:
- No use of rescue medication for systemic lupus erythematosus (SLE). (Use of corticosteroids equivalent to ≤7.5 mg/day prednisone is permitted.)
Measured: 24 weeks
Secondary outcomes (13)
Complete Renal Response (CRR) or Partial Renal Response (PRR) at each assessment Visit
PRR is defined as ≥50% reduction in UPCR compared with baseline.
Measured: Up to Week 52
Change From Baseline in Urine Protein-to-Creatinine Ratio (UPCR)
Change from baseline in UPCR measured in urine (mg/mg)
Measured: up to Week 52
Change From Baseline in Serum Creatinine
Change from baseline in serum creatinine. Unit of measure (mg/dL)
Measured: up to Week 52
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Change from baseline in eGFR. Unit of measure: mL/min/1.73 m²
Measured: up to Week 52
Change from baseline in UPCR, serum creatinine, urine protein, and eGFR
Composite evaluation of renal parameters including UPCR (mg/mg)
Measured: up to Week 52
Time to achieve UPCR ≤0.5
Time from baseline to first achievement of UPCR ≤0.5.
Measured: Up to Week 52
Change from baseline in SLEDAI-2K scores
Evaluation of change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Measured: Weeks 12, 24, and 52
Change From Baseline in Physician's Global Assessment at Week 12
Change in Physician's Global Assessment (PGA; scale 0-3)
Measured: Week 12
Change From Baseline in Physician's Global Assessment at Week 24
Change in Physician's Global Assessment (PGA; scale 0-3)
Measured: Week 24
Change From Baseline in Physician's Global Assessment at Week 52
Change in Physician's Global Assessment (PGA; scale 0-3)
Measured: Week 52
Achieving LLDAS at each assessment Visit
Percentage of participants achieving Low Lupus Disease Activity State (LLDAS)
Measured: Weeks 12, 24, and 52
Change from baseline in SF-36 scores
Change in health-related quality of life assessed by Short Form Health Survey-36 (SF-36)
Measured: Weeks 12, 24, and 52
Change from screening in immunology parameters
Composite evaluation of immunology markers including C3, C4 (mg/dL), anti-dsDNA antibody (IU/mL), and autoantibody titers (ANA, Anti-Sm, Anti-Ro 52/60, Anti-La). Each marker will be summarized separately and reported by its corresponding unit of measure.
Measured: up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Curocell Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364396
- Sponsor's protocol ID
- CRC01-02
- Acronym
- CRC01-02
- Status last verified
- Jan 2026
- First submitted
- 20 Aug 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Single-arm Phase 1/2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07364396
- Acronym / sponsor ID
- CRC01-02 / CRC01-02
- Conditions
- Lupus Nephritis, Lupus Nephritis (LN), SLE, SLE (Systemic Lupus)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Curocell Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 23 Jan 2026 (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.
The purpose of this clinical trial is to evaluate the safety and efficacy of CRC01, an investigational autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, in people with lupus nephritis (LN), a serious kidney complication of systemic lupus erythematosus (SLE).
The main objectives of the study are:
- To determine whether CRC01 infusion can improve kidney outcomes and reduce disease activity in participants with lupus nephritis.
- To assess the safety profile, including potential risks such as cytokine release syndrome (CRS) and neurotoxicity.
Study Design This is a single-arm, open-label, multi-center, Phase 1/2 study. All enrolled participants will receive CRC01 after screening and baseline assessments.
Study Procedures
Participants will:
- Undergo eligibility screening, including blood tests, urine tests, and disease activity assessments.
- Provide autologous T lymphocytes through a procedure called leukapheresis.
- Receive a lymphodepleting pre-conditioning regimen (short course of chemotherapy).
- Receive a single intravenous infusion of CRC01 cells.
- Be hospitalized for close monitoring to detect and manage early adverse events such as CRS or neurotoxicity.
- Return for scheduled follow-up assessments through Week 52 (12 months) post-infusion to evaluate safety and treatment response.
Key Outcomes
Researchers will measure:
- Changes in proteinuria and kidney function.
- Changes in disease activity scores.
- Incidence and severity of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRC01 | Experimental | Biological: CRC01Participants with lupus nephritis will receive a single intravenous infusion of CRC01 (autologous anti-CD19 CAR-T cells) following lymphodepleting pre-conditioning chemotherapy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age 19 years or older, voluntarily provides written informed consent.
- Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria.
- Positive antinuclear antibody (ANA) at screening (titer ≥1:80).
- Diagnosis of lupus nephritis Class III or IV (with or without concurrent Class V), confirmed by kidney biopsy within 1 year prior to screening based on ISN/RPS 2018 criteria.
- Inadequate response to, or intolerance of, at least two or more standard therapies for 6 months or longer (cyclophosphamide, mycophenolate mofetil, azathioprine, tacrolimus, rituximab, belimumab).
Key exclusion criteria (20 listed)
- Current or anticipated requirement for renal dialysis during the study.
- History of kidney transplantation or planned transplantation during the study.
- History of severe CNS lupus or currently active severe CNS lupus.
- Prior CAR-T cell therapy.
- History of malignancy except for: basal or squamous cell carcinoma of skin treated and disease-free ≥3 years; in-situ carcinoma of cervix or breast treated and disease-free ≥3 years; superficial bladder cancer treated and disease-free ≥3 years; completely resected primary malignancy in complete remission ≥5 years.
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 |
|---|---|---|
| CRC01Autologous T lymphocytes genetically modified to express anti-CD19 chimeric antigen receptor (CAR). Administered as a single intravenous infusion. | Biological | CRC01 |
Primary outcome
Phase 1 Study: To evaluate the tolerability of CRC01 in patients with severe refractory autoimmune disease (systemic lupus erythematosus), and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
Time frame: 28 day
Safety and tolerability will be assessed by: 1. Number of participants with dose-limiting toxicities (DLTs) within 28 days after CRC01 infusion, as assessed by CTCAE v5.0 and ASTCT consensus criteria.
Phase 1 Study: To evaluate the tolerability of CRC01 in patients with severe refractory autoimmune disease (systemic lupus erythematosus), and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
Time frame: 28 day
Safety and tolerability will be assessed by: 2. Determination of the maximum tolerated dose (MTD) defined as the highest dose level at which ≤1 of 6 participants experience a DLT.
Phase 1 Study: To evaluate the tolerability of CRC01 in patients with severe refractory autoimmune disease (systemic lupus erythematosus), and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
Time frame: 28 day
Safety and tolerability will be assessed by: 3. Determination of the recommended Phase 2 dose (RP2D) based on incidence of DLTs, safety profile, and investigator/sponsor assessment.
Phase 2 Study: To evaluate the efficacy of CRC01 by assessing Complete Renal Response (CRR)
Time frame: 24 weeks
Complete Renal Response (CRR): Defined as meeting all of the following criteria: 1. 24-hour urine protein ≤0.5 g, or urine protein-to-creatinine ratio (UPCR) ≤0.5. If a 24-hour urine collection is available and meets adequacy criteria, 24-hour urine protein assessment takes precedence. If the 24-hour urine collection is inadequate or not performed, UPCR will be used for evaluation.
Phase 2 Study: To evaluate the efficacy of CRC01 by assessing Complete Renal Response (CRR)
Time frame: 24 weeks
Complete Renal Response (CRR): Defined as meeting all of the following criteria: 2. eGFR ≥60 mL/min/1.73m², or a decrease in eGFR ≤20% compared with the pre-flare value.
Phase 2 Study: To evaluate the efficacy of CRC01 by assessing Complete Renal Response (CRR)
Time frame: 24 weeks
Complete Renal Response (CRR): Defined as meeting all of the following criteria: 3. No use of rescue medication for systemic lupus erythematosus (SLE). (Use of corticosteroids equivalent to ≤7.5 mg/day prednisone is permitted.)
13 secondary outcomes
Complete Renal Response (CRR) or Partial Renal Response (PRR) at each assessment Visit
Time frame: Up to Week 52
Change From Baseline in Urine Protein-to-Creatinine Ratio (UPCR)
Time frame: up to Week 52
Change From Baseline in Serum Creatinine
Time frame: up to Week 52
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: up to Week 52
Change from baseline in UPCR, serum creatinine, urine protein, and eGFR
Time frame: up to Week 52
Time to achieve UPCR ≤0.5
Time frame: Up to Week 52
Change from baseline in SLEDAI-2K scores
Time frame: Weeks 12, 24, and 52
Change From Baseline in Physician's Global Assessment at Week 12
Time frame: Week 12
Change From Baseline in Physician's Global Assessment at Week 24
Time frame: Week 24
Change From Baseline in Physician's Global Assessment at Week 52
Time frame: Week 52
Achieving LLDAS at each assessment Visit
Time frame: Weeks 12, 24, and 52
Change from baseline in SF-36 scores
Time frame: Weeks 12, 24, and 52
Change from screening in immunology parameters
Time frame: up to Week 52
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 23 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CRC01 in people with Lupus Nephritis and Lupus Nephritis (LN), run by Curocell Inc..
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 22 inclusion and 20 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 23 Jan 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Sihong Choi (+821033848516, sihong.choi@curocellbtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 Study: To evaluate the tolerability of CRC01 in patients with severe refractory autoimmune disease (systemic lupus erythematosus), and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) (time frame: 28 day). The study lists 6 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 23 Jan 2026.