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New treatment option for Autoimmune Diseases
Official title CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease
ClinicalTrials.gov ID: NCT07305116
What this study is testing
What is UCAR T-cell?
UCAR T-cell is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for autoimmune diseases.
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
- CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B cell mediated autoimmune disease.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 and older
You may be able to join if
- \- Common 1\. Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):
- Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; b. Hemoglobin ≥ 60 g/L; c. Platelet count ≥ 30 × 10⁹/L.
- Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is...
- Renal Function: eGFR ≥ 30 mL/min/1.73 m².(Participants with eGFR \< 30 mL/min/1.73 m² and/or those receiving renal replacement therapy may be...
- Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.
You likely can't join if
- 1\. people with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide...
- 2\. people with grade III or IV heart failure (NYHA classification). 3. Have a history of congenital heart disease or acute myocardial infarction...
- 4\. Uncontrollable infection, or active infection that requires systemic treatment at screening.
- 5\. Had active pulmonary tuberculosis at screening. 6. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and...
- 7\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or...
- 8\. Patients had active central nervous system disease. 9. Patients with malignant diseases such as tumors before screening. 10. Secondary or...
See the full eligibility criteria
Who can join
- \- Common 1\. Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):
- Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; b. Hemoglobin ≥ 60 g/L; c. Platelet count ≥ 30 × 10⁹/L.
- Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN...
- Renal Function: eGFR ≥ 30 mL/min/1.73 m².(Participants with eGFR \< 30 mL/min/1.73 m² and/or those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit...
- Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.
- Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%. 2. Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least...
- Age ≥ 5 years.
- Meets the 2012 SLICC or 2019 EULAR/ACR classification criteria for SLE.
- Must meet at least one of the following adequate treatment conditions: a) Treated with glucocorticoids (≥1 mg/kg/day prednisone or equivalent) plus one or more immunomodulatory agents (including cyclophosphamide, MMF...
- SLE disease activity: SLEDAI-2K score ≥ 8; or SLEDAI ≥ 6 plus at least one BILAG-2004 category A or two category B scores, or both.
- No occurrence of macrophage activation syndrome within 1 month prior to screening.
- Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc. MDR-SRNS
- Age ≥3 years old, gender unlimited.
- Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;
- Must meet at least one of the following adequate treatment conditions: a) have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms...
- Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS); IgA nephropathy
- Age: ≥ 5 years old, gender unlimited;
- IgA nephropathy pathologically confirmed by renal biopsy;
- Angiotensin-Converting Enzyme Inhibitors (ACE) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements: a) Combination or sequential treatment with...
- Exclude people with other secondary causes; exclude patients with uncontrolled blood pressure. Refractory/Relapsed/Progressive Systemic Sclerosis:
- Age: ≥ 5 years old, gender unlimited;
- Scleroderma fulfilling the 2013 ACR classification criteria
- Positive scleroderma-related antibodies.
- Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).
- Must meet at least one of the following adequate treatment conditions:
- Treated with glucocorticoids (≥0.5 mg/kg/day) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus...
- Meets criteria for rapidly progressive disease (see Appendix 1) and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed...
- Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.
- Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \>45 mmHg, or other severe involvement of major organs will be exclude. Refractory/Relapsed ANCA-Associated...
- Age: ≥ 5 years old, gender unlimited;
- Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR/EULAR classification criteria, including microscopic polyangiitis (MPA) and...
- Has received glucocorticoids (≥1 mg/kg/day) in combination with at least one immunosuppressant or biologic agent (including cyclophosphamide, rituximab, azathioprine, mycophenolate mofetil, methotrexate, leflunomide...
- Evidence of active vasculitis meeting the following criteria: For participants \<18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis...
- Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.
What rules you out
- 1\. people with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or people with a history of severe allergic reactions.
- 2\. people with grade III or IV heart failure (NYHA classification). 3. Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including...
- 4\. Uncontrollable infection, or active infection that requires systemic treatment at screening.
- 5\. Had active pulmonary tuberculosis at screening. 6. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal...
- 7\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles)...
- 8\. Patients had active central nervous system disease. 9. Patients with malignant diseases such as tumors before screening. 10. Secondary or congenital immunodeficiency. 11. History of any cardiac, endocrine...
- 12\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to...
- 13\. Received live vaccine within 4 weeks before screening. 14. Tested positive in Blood pregnancy test. 15. Patients who had participated in other clinical trials and received any intervention within 3 months before...
- 16\. 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...
- 17\. Any situation judged by the investigators that may increase the risk of the people or interfere with the clinical trial outcome
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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, 3 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.