Difficult to Treat Systemic Lupus ErythematosusEarly Phase 1IC19 CAR-TNCT06886919
Clinical Study Evaluating the Safety and Efficacy of IC19 CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus
A Early Phase 1 study testing Engineering of chimeric antigen receptors targeting CD19 in allogeneic T cells in people with Difficult to Treat Systemic Lupus Erythematosus, run by Beijing Immunochina Medical Science & Technology Co., Ltd..
Trial summary
This study is an open label, single arm exploratory clinical trial of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus. Patients who are still in an active state after systemic treatment using the standard treatment regimen specified in the treatment guidelines were selected to receive IC19 CAR-T… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Difficult to Treat Systemic Lupus Erythematosus
- What is being tested?
- Engineering of chimeric antigen receptors targeting CD19 in allogeneic T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2025to 30 May 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with systemic lupus erythematosus who meet the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE;
- Prior to screening, treatment with glucocorticoids (sufficient or shock therapy) combined with immunosuppressants (cyclophosphamide, mycophenolate mofetil, antimalarial drugs, azathioprine, methotrexate, leflunomide, tacrolimus, cyclosporine, etc.) and at least one biological agent (rituximab, belimumab, tacrolizumab, etc.) must have been received for at least 2 months, and the dosage must be stable for more than 2 weeks. The disease should still be active or recur after disease remission.
- Oral corticosteroids need to meet the following conditions:
- Prednisone (or equivalent) ≥ 7.5 mg/day and ≤ 60 mg/day;
- When used in combination with immunosuppressants and/or biologics, there is no minimum daily dose requirement for glucocorticoids.
- 3. When screening, the disease activity score (SLEDAI-2000) should be ≥ 8 points; 4. During the screening period, it meets the criteria of being positive for anti nuclear antibodies (ANAs), anti dsDNA antibodies, or anti Smith antibodies.
Show all 14Show fewer
- 5. Age range of 18-70 years old (including threshold), gender not limited; 6. Expected survival period of more than 3 months; 7. The functions of important organs meet the following requirements:
- The bone marrow function needs to meet the following requirements: a. Neutrophil count ≥ 1 × 109/L; b. Platelets ≥ 50 × 109/L; c. Hemoglobin ≥ 60g/L;
- Liver function: ALT ≤ 2.5 × ULN (upper limit of normal, ULN), AST ≤ 2.5 × ULN; TBIL ≤ 1.5 × ULN (for subjects with Gilbert syndrome, ALT and AST ≤ 5 × ULN, total bilirubin ≤ 3.0 × ULN);
- Renal function: creatinine ≤ 1.5 × ULN or creatinine clearance rate (CrCl) ≥ 40 ml/min (Cockcroft/Gault formula);
- Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN;
- Cardiac function: Good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 50%;
- Finger pulse oxygen saturation ≥ 92% in non oxygen state; 8. Women of childbearing age who have a negative blood pregnancy test before the start of the trial and agree to participate in the trial until the last time Visit individuals who have adopted effective contraceptive measures; Male participants with reproductive partners agree to take effective contraceptive measures during the trial period until the last follow-up; And not in the lactation period.
- 9. The individual or legal guardian agrees to participate in this experiment and signs the informed consent form.
Who cannot join
- Diseases of the central nervous system that have clinical significance in the past or during screening, such as seizures, epilepsy, epileptic seizures, cerebrovascular disease (ischemia/hemorrhage), cerebral edema, reversible posterior white matter encephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, encephalitis, CNS vasculitis, or psychiatric disorders;
- Screening for acute severe lupus nephritis within the first 2 months, defined as significant deterioration of kidney disease (such as the presence of urine sediment and other laboratory abnormalities) that the researcher believes may require the use of contraindicated drugs or high-dose corticosteroids (prednisone ≥ 100 mg/d or equivalent corticosteroid treatment ≥ 14 days) for treatment in the first 2 months of the study.
- If there is an uncontrolled lupus crisis within the first 2 months of screening, the researcher has assessed that it is not suitable to participate in this study;
- A large amount of serous fluid accumulation (such as pleural effusion and peritoneal effusion) with compression symptoms that cannot be controlled after treatment;
- Other active autoimmune diseases (such as Crohn's disease and rheumatoid arthritis) that require systemic immunosuppressive therapy within the first 2 years of screening, except for SLE;
- Patients who have received or are waiting for hematopoietic stem cell/bone marrow transplantation or organ transplantation in the past;
Show all 20Show fewer
- Individuals who have previously received gene modified cell therapy, such as TCR-T therapy, CAR-T therapy, etc;
- Screening for clinical study drugs used for any other autoimmune diseases within the first 3 months. But if the research treatment is ineffective or if the disease progresses, and at least 5 half lives have passed before screening, it is allowed to be included in the group;
- Have a history of ≥ grade 2 bleeding within 30 days prior to screening, or require long-term continuous use of anticoagulant drugs (such as warfarin, low molecular weight heparin, or Xa factor inhibitors) for treatment;
- Vaccination with live or attenuated vaccines within 6 weeks prior to screening;
- Active hepatitis B or hepatitis C virus is defined as: subjects who are positive for hepatitis B B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and whose peripheral blood HBV-DNA detection is higher than the lower limit of detection (HBsAg positive but whose peripheral blood HBV-DNA detection is lower than the lower limit of detection according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B, Version 2022, at least 4 weeks of antiviral treatment shall be carried out before the first use of the study drug, and antiviral treatment shall be continued for 6-12 months during the study process, and the levels of HBV-DNA, HBsAg and ALT shall be monitored every 1-3 months); Hepatitis C virus (HCV) antibody positive and peripheral blood HCV-RNA detection above the detection limit; HIV antibody positive; Positive syphilis antibody;
- 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);
- Within the past year, there have been severe chronic obstructive pulmonary disease, interstitial lung disease, severe asthma, and clinically significant abnormalities in lung function tests, such as moderate to severe pulmonary arterial hypertension (average pulmonary arterial pressure detected by echocardiography>60mmHg) that require oxygen storage mask oxygen therapy or non-invasive or invasive ventilator assisted breathing during screening; Interstitial lung disease related to autoimmune diseases must meet all inclusion criteria;
- Hypertension with poor drug control (systolic blood pressure>160mmHg and/or diastolic blood pressure>90mmHg) or a history of any of the following cardiovascular diseases within 6 months prior to screening: long QTc syndrome or QTc interval>480 ms; Complete left bundle branch block, grade II/III atrioventricular block; Severe and uncontrolled arrhythmias requiring medication treatment; History of chronic congestive heart failure and NYHA ≥ 3 (refer to Appendix 2) with a heart ejection fraction below 50% within the 6 months prior to screening; Heart valve disease with CTCAE ≥ 3 grade; Within the first 6 months of screening, there has been a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina, severe pericardial disease, or other clinically significant heart diseases;
- History of symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months prior to the start of screening;
- Other untreated malignant tumors within the past 5 years or simultaneously, excluding cervical cancer in situ, basal cell carcinoma of the skin, and ductal carcinoma in situ of the breast;
- Infections (fungi, bacteria, viruses, or others) that require intravenous injection of antibiotics for control or are uncontrollable For simple urinary tract infections and bacterial pharyngitis, if the researchers evaluate that they can be controlled through treatment, they can be included in the study;
- Individuals who are known to have allergic reactions, hypersensitivity reactions, intolerance, or contraindications to any ingredients of drugs that may be used in the study (including fludarabine, cyclophosphamide, tocilizumab, albumin), or who have previously experienced severe allergic reactions;
- Have a history of alcohol or drug abuse in the past 24 weeks;
- The researcher shall determine whether the subjects have any factors that affect compliance with the protocol, or are unwilling or unable to comply with the procedures required in the research protocol.
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
This study is an open label, single arm exploratory clinical trial of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus. Patients who are still in an active state after systemic treatment using the standard treatment regimen specified in the treatment guidelines were selected to receive IC19 CAR-T cell single pulse infusion therapy.
Read the detailed description
- The "3+3" dose escalation method will be adopted, with 1 × 10 ^ 8 CAR-T cells/dose and 2 × 10 ^ 8 CAR-T cells/dose, and two dose groups increasing sequentially. Due to the specificity of cell preparations, it is allowed for the actual dosage of each dose group to fluctuate by ± 30%.
- Three subjects are enrolled in each dose group first, and within the same dose group, the cell transfusion interval between the first two subjects should not be less than 14 days. If no dose limiting toxicity (DLT) is observed in a certain dose group, the dose will be increased to the next dose; If one case of DLT occurs, this dose group needs to be divided into three additional subjects (a total of six subjects). If no new DLT occurs, the dosage will be increased to the next dose; If more than 1/6 of the 6 subjects develop DLT, the dose escalation will be terminated, and the Safety Review Committee (SRC) will discuss whether to reduce the dose and continue the monotherapy study.
- Definition of DLT: Any of the following events related to the investigational drug (definitely related, likely related, possibly related) that occur within 28 days after a subject receives any IC19 CAR-T cell infusion:
- Any grade 4 or 5 adverse events related to IC19 CAR-T cells that occur after treatment, excluding laboratory test indicators of no clinical significance; 2) Any grade 3 adverse events related to IC19 CAR-T cells that occur after treatment and do not improve to ≤ grade 2 within 7 days, excluding clinically insignificant laboratory test indicators; 3) Any grade 3 epileptic seizures that occur after treatment and cannot be relieved to ≤ grade 2 within 3 days;
The following expected events will not be considered DLT:
Hematology:
- Grade 3 neutropenia or Grade 4 neutropenia lasting no more than 28 days;
- Grade 3 or 4 leukopenia;
- Grade 3 or 4 lymphocyte reduction;
- Grade 3 anemia or Grade 4 anemia lasting no more than 28 days;
- Grade 3 thrombocytopenia or Grade 4 thrombocytopenia lasting no more than 28 days;
- Other types of blood cell reduction besides those mentioned above.
Non hematology:
- Grade 3 transaminase and bilirubin elevation should be restored to ≤ Grade 2 within 2 weeks;
- Grade 3 hemophagocytic syndrome recovers to ≤ Grade 2 within 2 weeks;
- Grade 3 chills, recover to ≤ Grade 2 within ≤ 72 hours;
- Grade 3 hypotension (without other CRS symptoms), requiring vasopressor support and recovering to ≤ Grade 2 within ≤ 72 hours;
- Level 3 CRS, recover to ≤ Level 2 within ≤ 72 hours;
- Grade 3 ICANS ≤ 7 days, with remission to ≤ Grade 2 within 1 week and remission to baseline within ≤ 28 days.
For grade 3 or 4 toxicity that occurs after 28 days of IC19 CAR-T cell transfusion, SRC will discuss the specific situation. In this study, except for CRS and ICANS, which will be classified according to the ASTCT 2019 consensus grading criteria, adverse events of subjects will be classified according to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE 5.0).
- Being tested
- Engineering of chimeric antigen receptors targeting CD19 in allogeneic T cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engineering of chimeric antigen receptors targeting CD19 in allogeneic T cellsBiological
Also called IC19 CAR-T cells
About 6 subjects will be included in the study, and a "3+3" dose escalation method will be used. The dosage will be gradually increased in two dose groups: 1 × 10 ^ 8 CAR-T cells/dose and 2 × 10 ^ 8 CAR-T cells/dose. Three subjects are enrolled in each dose group first, and within the same dose group, the cell transfusion interval between the first two subjects should not be less than 14 days. If no dose limiting toxicity (DLT) is observed in a certain dose group, the dose will be increased to the next dose; If one case of DLT occurs, this dose group needs to be divided into three additional subjects (a total of six subjects). If no new DLT occurs, the dosage will be increased to the next dose; If more than 1/6 of the 6 subjects develop DLT, the dose escalation will be terminated, and the Safety Review Committee (SRC) will discuss whether to reduce the dose and continue the monotherapy study.
| Study group | Role | What they receive |
|---|---|---|
| Patients with refractory systemic lupus erythematosus | Experimental | The "3+3" dose escalation method will be adopted, with 1 × 10 ^ 8 CAR-T cells/dose and 2 × 10 ^ 8 CAR-T cells/dose, and two dose groups increasing sequentially. Due to the specificity of cell preparations, it is allowed for the actual dosage of each dose group to fluctuate by ± 30%. Receives: Biological: Engineering of chimeric antigen receptors targeting CD19 in allogeneic T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus
The incidence of adverse events related to IC19 CAR-T cell transfusion within 28 days after IC19 CAR-T cell transfusion, abnormal laboratory test results with clinical significance, including dose limited toxicity (DLT).
Measured: 28 days after IC19 CAR-T cell transfusion
Secondary outcomes (13)
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
Changes in SLE Disease Activity Index (SLEDAI-2K) scores (0-105 points; 0-4 points: almost no activity; 5-9 points: mild activity; 10-14 points: moderate activity; ≥ 15 points: severe activity) compared to baseline at 12 and 24 weeks after IC19 CAR-T cell transfusion
Measured: 24 weeks after IC19 CAR-T cell reinfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
Changes in the British Islet Lupus Assessment Group Index (BILAG-2004) compared to baseline at 12 and 24 weeks after IC19 CAR-T cell reinfusion
Measured: 24 weeks after IC19 CAR-T cell reinfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
The overall assessment (PGA) of clinical physicians at 12 and 24 weeks after IC19 CAR-T cell reinfusion compared to baseline changes
Measured: 24 weeks after IC19 CAR-T cell reinfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
The proportion of subjects who reached SLE response index 4 (SRI-4) at 12 and 24 weeks after IC19 CAR-T cell reinfusion
Measured: 24 weeks after IC19 CAR-T cell reinfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
The proportion of subjects who reached lupus low disease activity state (LLDAS) at 12 and 24 weeks after IC19 CAR-T cell reinfusion
Measured: 24 weeks after IC19 CAR-T cell reinfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
Proportion of subjects who achieved disease remission (DORIS) after IC19 CAR-T cell transfusion at 12 and 24 weeks
Measured: 24 weeks after IC19 CAR-T cell reinfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
Changes in Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) from baseline at 12 and 24 weeks after IC19 CAR-T cell reinfusion
Measured: 24 weeks after IC19 CAR-T cell reinfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
The changes in various indicators from baseline at other time points after IC19 CAR-T cell transfusion, such as weeks 4, 8, 16, 20, 36, and 48, as mentioned in items 1-7 above
Measured: 48 weeks after IC19 CAR-T cell transfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
Changes in quality of life (SF-36) compared to baseline at 12, 24, and 48 weeks after IC19 CAR-T cell transfusion
Measured: 48 weeks after IC19 CAR-T cell transfusion
Evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus
Changes in immunoglobulin (IgG, IgM, IgA, IgE), antibody (anti ds DNA antibody, anti nuclear antibody ANA), and complement (C3, C4) levels after IC19 CAR-T cell transfusion
Measured: 48 weeks after IC19 CAR-T cell transfusion
Evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus
After IC19 CAR-T cell transfusion, the peak time (Tmax), amplification peak (Cmax), area under the curve (AUC), and retention time of CAR-T cells in the patient's peripheral blood
Measured: 48 weeks after IC19 CAR-T cell transfusion
Evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus
Changes in CD19+B cell levels and major B cell functional subgroups (initial B cells, memory B cells, category switching B cells) in peripheral blood after IC19 CAR-T cell transfusion
Measured: 48 weeks after IC19 CAR-T cell transfusion
Evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus
The level of anti drug antibodies (ADA) after IC19 CAR-T cell reinfusion
Measured: 48 weeks after IC19 CAR-T cell transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start31 Mar 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult to Treat Systemic Lupus ErythematosusStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- yajing Zhang, doctorate, Principal investigator, Beijing Gaobo Boren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886919
- Sponsor's protocol ID
- ZMA03
- Acronym
- IC19 CAR-T
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Safety and Efficacy of IC19 CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06886919
- Acronym / sponsor ID
- IC19 CAR-T / ZMA03
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 20 Mar 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.
This study is an open label, single arm exploratory clinical trial of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus. Patients who are still in an active state after systemic treatment using the standard treatment regimen specified in the treatment guidelines were selected to receive IC19 CAR-T cell single pulse infusion therapy.
Detailed description
- The "3+3" dose escalation method will be adopted, with 1 × 10 ^ 8 CAR-T cells/dose and 2 × 10 ^ 8 CAR-T cells/dose, and two dose groups increasing sequentially. Due to the specificity of cell preparations, it is allowed for the actual dosage of each dose group to fluctuate by ± 30%.
- Three subjects are enrolled in each dose group first, and within the same dose group, the cell transfusion interval between the first two subjects should not be less than 14 days. If no dose limiting toxicity (DLT) is observed in a certain dose group, the dose will be increased to the next dose; If one case of DLT occurs, this dose group needs to be divided into three additional subjects (a total of six subjects). If no new DLT occurs, the dosage will be increased to the next dose; If more than 1/6 of the 6 subjects develop DLT, the dose escalation will be terminated, and the Safety Review Committee (SRC) will discuss whether to reduce the dose and continue the monotherapy study.
- Definition of DLT: Any of the following events related to the investigational drug (definitely related, likely related, possibly related) that occur within 28 days after a subject receives any IC19 CAR-T cell infusion:
- Any grade 4 or 5 adverse events related to IC19 CAR-T cells that occur after treatment, excluding laboratory test indicators of no clinical significance; 2) Any grade 3 adverse events related to IC19 CAR-T cells that occur after treatment and do not improve to ≤ grade 2 within 7 days, excluding clinically insignificant laboratory test indicators; 3) Any grade 3 epileptic seizures that occur after treatment and cannot be relieved to ≤ grade 2 within 3 days;
The following expected events will not be considered DLT:
Hematology:
- Grade 3 neutropenia or Grade 4 neutropenia lasting no more than 28 days;
- Grade 3 or 4 leukopenia;
- Grade 3 or 4 lymphocyte reduction;
- Grade 3 anemia or Grade 4 anemia lasting no more than 28 days;
- Grade 3 thrombocytopenia or Grade 4 thrombocytopenia lasting no more than 28 days;
- Other types of blood cell reduction besides those mentioned above.
Non hematology:
- Grade 3 transaminase and bilirubin elevation should be restored to ≤ Grade 2 within 2 weeks;
- Grade 3 hemophagocytic syndrome recovers to ≤ Grade 2 within 2 weeks;
- Grade 3 chills, recover to ≤ Grade 2 within ≤ 72 hours;
- Grade 3 hypotension (without other CRS symptoms), requiring vasopressor support and recovering to ≤ Grade 2 within ≤ 72 hours;
- Level 3 CRS, recover to ≤ Level 2 within ≤ 72 hours;
- Grade 3 ICANS ≤ 7 days, with remission to ≤ Grade 2 within 1 week and remission to baseline within ≤ 28 days.
For grade 3 or 4 toxicity that occurs after 28 days of IC19 CAR-T cell transfusion, SRC will discuss the specific situation. In this study, except for CRS and ICANS, which will be classified according to the ASTCT 2019 consensus grading criteria, adverse events of subjects will be classified according to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE 5.0).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with refractory systemic lupus erythematosus | Experimental | Biological: Engineering of chimeric antigen receptors targeting CD19 in allogeneic T cellsThe "3+3" dose escalation method will be adopted, with 1 × 10 ^ 8 CAR-T cells/dose and 2 × 10 ^ 8 CAR-T cells/dose, and two dose groups increasing sequentially. Due to the specificity of cell preparations, it is allowed for the actual dosage of each dose group to fluctuate by ± 30%. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects diagnosed with systemic lupus erythematosus who meet the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE;
- Prior to screening, treatment with glucocorticoids (sufficient or shock therapy) combined with immunosuppressants (cyclophosphamide, mycophenolate mofetil, antimalarial drugs, azathioprine, methotrexate, leflunomide, tacrolimus, cyclosporine, etc.) and at least one biological agent (rituximab, belimumab, tacrolizumab, etc.) must have been received for at least 2 months, and the dosage must be stable for more than 2 weeks. The disease should still be active or recur after disease remission.
- Prednisone (or equivalent) ≥ 7.5 mg/day and ≤ 60 mg/day;
- When used in combination with immunosuppressants and/or biologics, there is no minimum daily dose requirement for glucocorticoids.
- 3. When screening, the disease activity score (SLEDAI-2000) should be ≥ 8 points; 4. During the screening period, it meets the criteria of being positive for anti nuclear antibodies (ANAs), anti dsDNA antibodies, or anti Smith antibodies.
Key exclusion criteria (20 listed)
- Diseases of the central nervous system that have clinical significance in the past or during screening, such as seizures, epilepsy, epileptic seizures, cerebrovascular disease (ischemia/hemorrhage), cerebral edema, reversible posterior white matter encephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, encephalitis, CNS vasculitis, or psychiatric disorders;
- Screening for acute severe lupus nephritis within the first 2 months, defined as significant deterioration of kidney disease (such as the presence of urine sediment and other laboratory abnormalities) that the researcher believes may require the use of contraindicated drugs or high-dose corticosteroids (prednisone ≥ 100 mg/d or equivalent corticosteroid treatment ≥ 14 days) for treatment in the first 2 months of the study.
- If there is an uncontrolled lupus crisis within the first 2 months of screening, the researcher has assessed that it is not suitable to participate in this study;
- A large amount of serous fluid accumulation (such as pleural effusion and peritoneal effusion) with compression symptoms that cannot be controlled after treatment;
- Other active autoimmune diseases (such as Crohn's disease and rheumatoid arthritis) that require systemic immunosuppressive therapy within the first 2 years of screening, except for SLE;
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 |
|---|---|---|
| Engineering of chimeric antigen receptors targeting CD19 in allogeneic T cellsAlso: IC19 CAR-T cellsAbout 6 subjects will be included in the study, and a "3+3" dose escalation method will be used. The dosage will be gradually increased in two dose groups: 1 × 10 ^ 8 CAR-T cells/dose and 2 × 10 ^ 8 CAR-T cells/dose. Three subjects are enrolled in each dose group first, and within the same dose group, the cell transfusion interval between the first two subjects should not be less than 14 days. If no dose limiting toxicity (DLT) is observed in a certain dose group, the dose will be increased to the next dose; If one case of DLT occurs, this dose group needs to be divided into three additional subjects (a total of six subjects). If no new DLT occurs, the dosage will be increased to the next dose; If more than 1/6 of the 6 subjects develop DLT, the dose escalation will be terminated, and the Safety Review Committee (SRC) will discuss whether to reduce the dose and continue the monotherapy study. | Biological | Patients with refractory systemic lupus erythematosus |
Primary outcome
Evaluate the safety of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus
Time frame: 28 days after IC19 CAR-T cell transfusion
The incidence of adverse events related to IC19 CAR-T cell transfusion within 28 days after IC19 CAR-T cell transfusion, abnormal laboratory test results with clinical significance, including dose limited toxicity (DLT).
13 secondary outcomes
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
Time frame: 24 weeks after IC19 CAR-T cell reinfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
Time frame: 24 weeks after IC19 CAR-T cell reinfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
Time frame: 24 weeks after IC19 CAR-T cell reinfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
Time frame: 24 weeks after IC19 CAR-T cell reinfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
Time frame: 24 weeks after IC19 CAR-T cell reinfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
Time frame: 24 weeks after IC19 CAR-T cell reinfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
Time frame: 24 weeks after IC19 CAR-T cell reinfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
Time frame: 48 weeks after IC19 CAR-T cell transfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
Time frame: 48 weeks after IC19 CAR-T cell transfusion
Evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus
Time frame: 48 weeks after IC19 CAR-T cell transfusion
Evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus
Time frame: 48 weeks after IC19 CAR-T cell transfusion
Evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus
Time frame: 48 weeks after IC19 CAR-T cell transfusion
Evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus
Time frame: 48 weeks after IC19 CAR-T cell transfusion
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 24 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Difficult to Treat Systemic Lupus Erythematosus
Not yet recruitingPhase 3
Lenalidomide vs Methotrexate in Difficult-to-treat Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE)
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.
yajing Zhang, doctorate principal investigator
Beijing Gaobo Boren Hospital
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Engineering of chimeric antigen receptors targeting CD19 in allogeneic T cells in people with Difficult to Treat Systemic Lupus Erythematosus, run by Beijing Immunochina Medical Science & Technology Co., Ltd..
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 14 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 24 Mar 2025. 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?
Evaluate the safety of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus (time frame: 28 days after IC19 CAR-T cell transfusion). 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 24 Mar 2025.