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New treatment option for Refractory Lupus Nephritis
Official title CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH
ClinicalTrials.gov ID: NCT06947460
What this study is testing
What is CD19-BCMA CAR-T cells infusion?
CD19-BCMA CAR-T cells infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for refractory lupus nephritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) receive CD19-BCMA CAR T cell therapy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 65
You may be able to join if
- Refractory Lupus Nephritis（LN）: Patients who meet all the following requirements can be enrolled in the group. Definition: Failure to achieve...
- Male or female, aged 10-65 years;
- Meeting the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for Systemic Lupus...
- The ANA result is positive which means ANA titer≥ 1:80 (based on the equivalent detection results by Hep-2 immunofluorescence assay or enzyme immune...
- B cell CD19+ expression, and stop using immunosuppressant more than one week.
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study: 1\. Refractory Lupus Nephritis (LN):
- Intracranial hypertension or disorder of consciousness;
- Symptomatic heart failure or severe arrhythmia;
- Symptoms of severe respiratory failure;
- Complicated with other types of malignant tumors;
- Diffuse intravascular coagulation;
See the full eligibility criteria
Who can join
- Refractory Lupus Nephritis（LN）: Patients who meet all the following requirements can be enrolled in the group. Definition: Failure to achieve induction remission after 3 to 6 months of treatment with at least one...
- Male or female, aged 10-65 years;
- Meeting the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for Systemic Lupus Erythematosus (Appendix 4);
- The ANA result is positive which means ANA titer≥ 1:80 (based on the equivalent detection results by Hep-2 immunofluorescence assay or enzyme immune assay), and/or according to the detection results from center...
- B cell CD19+ expression, and stop using immunosuppressant more than one week.
- The lymphocyte count in the subject's blood routine \>0.5×109/L, and no contraindications for cell collection;
- No serious allergic constitution;
- ECOG score: 0-2:
- Expected survival ≥90 days: people and/or their guardian can understand and sign the informed consent form. 2\. SSc: Patients who meet all the following requirements can be enrolled in the group.
- Patients or their legal representatives sign the informed consent form;
- Male or female, aged 18-65 years.
- According to the SSc classification criteria proposed by American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR), chose the highest score under the same condition. If the score ≥9, it can be...
- Satisfy a sufficient condition: the skin on the fingers of both hands is thickened and extend to the proximal end of metacarpophalangeal joint;
- The lymphocyte count in the subject's blood routine \>0.5×109/L, and no contraindications for cell collection. 3\. pSS-PAH: Patients who meet all the following requirements can be enrolled in the group.
- Patients or their legal representatives sign the informed consent form;
- Male or female, aged 18-65 years;
- Refractory connective tissue disease (PAH)patients: a) Satisfy the 2002 AECG or 2016 ACR/2016 EULAR classification criteria, can be diagnosed as pSS (Appendix 6); b) Confirmed by Right heart catheterization, satisfy the...
- Low-risk patients whose PAH do not reach the risk stratification. The patients should meet: WHO cardiac function grading I-II; 6 minutes walking distance\>440 m; BNP\<50ng/L or NT-proBNP\<300ng/L; RAP\<8mmHg and CI≥2.5...
- people have received standard treatment in stable dose before first use of study drug, include: Glucocorticoids (prednisone 0-30mg/day, or other equivalent preparations) ≥4 weeks; Antimalarial drugs, single-agent...
- After clinician evaluate the disease condition of patients, they will allow using glucocorticoids no more than 10mg or other equivalent dose and stop all immunosuppressants (exclued hydroxychloroquine);
- Reproductive-aged female patients with negative blood human chorionic gonadotropin (HCG) test within 7 days before trial pre-conduct treatment; Any child-bearing male and female patients must agree to take effective...
- Have appropriate organ function, the criteria are as follows: a) AST≤3 times upper limit of normal (ULN); b) ALT ≤3 times ULN; c) T-Bil ≤2 times ULN, unless the patient has a record of Gilbert syndrome; Patients with...
- Male or female, aged 10-65 years; Patients who do not meet the inclusive criteria of three groups above, meet any one below can be enrolled.
- ANA titer\<1:80 (based on the equivalent detection results by Hep-2 immunofluorescence assay or enzyme immune assay), and/or during the screening visit, by the detection results from center laboratory, anti dsDNA serum...
- In conventional therapy, occur recurrent infections, leading to intolerance of conventional therapy, but no active infection, serious infection(tuberculosis) currently;
- Patients who cannot use drugs anymore, because of bone infarction, osteonecrosis, severe bone pain caused by long term use of drugs.
- Patients who cannot use drugs anymore, because of vision changes, retinopathy, fundus hemorrhage caused by long term use of drugs.
- Patients who cannot use drugs anymore, because of endocrine-related changes (premature closure of the femoral shaft, severe obesity, diabetes, impact on growth and development, etc.) caused by long term use of drugs.
- Severe toxicity of blood system (≥grade3; neutrophil\<1\ 10\^9/L,platelet\<50\ 10\^9/L,hemoglobin\<80g/L);
- Abnormal liver function (ALT ≥3 times ULN; ALT≥3 times ULN; T-Bil ≥2 times ULN);
- After 3 months of regular treatment, there are still have disease progression (eg. urine protein index increased by 3 times);
- Previously received CAR-T therapies, there are still have disease progression.
What rules you out
- An individual who meets any of the following criteria will be excluded from participation in this study: 1\. Refractory Lupus Nephritis (LN):
- Intracranial hypertension or disorder of consciousness;
- Symptomatic heart failure or severe arrhythmia;
- Symptoms of severe respiratory failure;
- Complicated with other types of malignant tumors;
- Diffuse intravascular coagulation;
- Suffering from septicemia or other uncontrollable infections;
- Patients with uncontrollable diabetes and other endocrine diseases;
- Severe mental disorders;
- Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI);
- Have received organ transplantation (excluding bone marrow transplant);
- Reproductive-aged female patients with positive blood human chorionic gonadotropin (HCG) test;
- Positive screening for hepatitis (HBV and HCV included), HIV and syphilis;
- The subject is unable to undergo PBMC collection, nor are there cryopreserved PBMCs available for CAR-T cell manufacturing;
- eGFR CKD-EPI \< 30 ml/min/1.73m\^2;
- Any active skin disease that may interfere with the assessment of systemic lupus erythematosus (SLE) research, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE cutaneous...
- Previously received other CAR-T therapies except CD19-CART. 2.SSc
- Other connective tissue disease: Rheumatoid Arthritis, System Lupus or Inflammatory Myopathies;
- Clinical manifestations can be explained by disease similar to SSc: hand joint lesions related to nephrogenic systemic fibrosis, generalized morphea, eosinophilic fasciitis, diabetic scleredema, scleromyxedema...
- Patients who have severe active central nervous system (CNS) lupus, including epileptic seizures, pyschosis, cerebrovascular accident or CNS vasculitis requiring treatment intervention within 60 days after baseline;
- Dialysis patients or Ccr \<30ml/min;
- Pregnant or suckling period;
- Combined with active infection (eg. septicemia, bacteremia, fungemia, uncontrolled pulmonary infection, and active tuberculosis);
- Detection positive: HBsAg, HbeAg; HBe-Ab, HBc-Ab (the copy number of HBV-DNA is greater than the measurable low limit); HCV-Ab, HIV-Ab, TP-Ab;
- Patients have undergone big surgeries which evaluated by investigators as unsuitable for enrollment within 4 weeks before screening;
- Previously received other CAR-T therapies except CD19-CART. 3.pSS-PAH
- PH caused by other reasons: Portal hypertension, hereditary hemorrhagic telangiectasia, etc.; congenital heart disease; suspected drugs and toxicants; pulmonary hypertension related to chronic hypoxic diseases: moderate...
- Patients who have severe active central nervous system (CNS) lupus, including epileptic seizures, pyschosis, cerebrovascular accident or CNS vasculitis requiring treatment intervention within 60 days after baseline;
- Dialysis patients or Ccr \<30ml/min;
- Pregnant or suckling period;
- Combined with active infection (eg. septicemia, bacteremia, fungemia, uncontrolled pulmonary infection, and active tuberculosis).
- Detection positive: HBsAg, HbeAg; HBe-Ab, HBc-Ab (the copy number of HBV-DNA is greater than the measurable low limit); HCV-Ab, HIV-Ab, TP-Ab;
- Patients have undergone big surgeries which evaluated by investigators as unsuitable for enrollment within 4 weeks before screening;
- Previously received other CAR-T therapies except CD19-CART. 6) Detection positive: HBsAg, HbeAg; HBe-Ab, HBc-Ab (the copy number of HBV-DNA is greater than the measurable low limit); HCV-Ab, HIV-Ab, TP-Ab; 7) Patients...
- Intracranial hypertension or disorder of consciousness;
- Symptomatic heart failure or severe arrhythmia;
- Symptoms of severe respiratory failure;
- Complicated with other types of malignant tumors;
- Diffuse intravascular coagulation;
- Suffering from septicemia or other uncontrollable infections;
- Patients with uncontrollable diabetes and other endocrine diseases;
- Severe mental disorders;
- Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI);
- Have received organ transplantation (excluding bone marrow transplant);
- Reproductive-aged female patients with positive blood human chorionic gonadotropin (HCG) test;
- Positive screening for hepatitis (HBV and HCV included), HIV and syphilis;
- The subject is unable to undergo PBMC collection, nor are there cryopreserved PBMCs available for CAR-T cell manufacturing;
- eGFR CKD-EPI \< 30 ml/min/1.73m\^2.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China,Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China,Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.