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New treatment option for Systemic Lupus Erythematosus
Official title Study of CD19 CAR-T Therapy for Refractory SLE
ClinicalTrials.gov ID: NCT07403097
What this study is testing
What is PTOC1?
PTOC1 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for systemic lupus erythematosus.
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 an investigator-initiated trial aimed at assessing the safety and efficacy of PTOC1 cells Injection in the treatment of refractory systemic lupus erythematosus.
- 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 5 and older
You may be able to join if
- Age ≥ 5 years, no gender limitation;
- Diagnosed with SLE according to the 2019 EULAR/ACR classification criteria, and still in moderate to severe disease activity despite ≥ 3 months of...
- SLEDAI-2K score ≥ 8 points;
- The functions of vital organs must meet the following requirements:
- cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%, with no obvious abnormalities on electrocardiogram (ECG);
You likely can't join if
- Central nervous system (CNS) diseases: presence of CNS lupus symptoms requiring intervention within 60 days, including epilepsy, confusion...
- Congenital heart disease or severe arrhythmia before screening: Including multifocal and frequent supraventricular tachycardia, ventricular...
- Presence of active infections requiring systemic treatment or uncontrolled infections within 3 months prior to screening;
- Having received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; or having grade 2 or above...
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA level...
- History of macrophage activation syndrome within 1 month prior to screening (except for those for whom the investigator has determined that safety...
See the full eligibility criteria
- Age ≥ 5 years, no gender limitation;
- Diagnosed with SLE according to the 2019 EULAR/ACR classification criteria, and still in moderate to severe disease activity despite ≥ 3 months of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount...
- SLEDAI-2K score ≥ 8 points;
- The functions of vital organs must meet the following requirements:
- cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%, with no obvious abnormalities on electrocardiogram (ECG);
- renal function: eGFR ≥ 30 mL/min/1.73m2;
- hepatic function: AST and ALT ≤ 3.0×ULN, total bilirubin ≤ 2.0×ULN;
- pulmonary function: no severe pulmonary lesions; blood oxygen saturation ≥ 92% under non-oxygen supplementation conditions.
- Meet the criteria of leukapheresis or intravenous blood collection, and no contraindication for leukapheresis;
- Negative pregnancy test for female people of childbearing age, and agree to take effective contraceptive measures until one year after infusion;
- Participant or his/her guardians agree to participate in the clinical trial and sign the informed consent form indicating that he/she understands the purpose and procedure of the clinical trial and is willing to...
- Central nervous system (CNS) diseases: presence of CNS lupus symptoms requiring intervention within 60 days, including epilepsy, confusion, cerebrovascular events, etc;
- Congenital heart disease or severe arrhythmia before screening: Including multifocal and frequent supraventricular tachycardia, ventricular tachycardia, etc.; or complicated with moderate to large pericardial effusion...
- Presence of active infections requiring systemic treatment or uncontrolled infections within 3 months prior to screening;
- Having received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; or having grade 2 or above acute graft-versus-host disease (GVHD) within 2 weeks prior to...
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA level exceeding the normal range; positive for hepatitis C virus (HCV) antibody...
- History of macrophage activation syndrome within 1 month prior to screening (except for those for whom the investigator has determined that safety risks are excluded after treatment);
- History of previous CAR-T therapy (except for those for whom the investigator has determined that safety risks are excluded after treatment);
- Presence of active pulmonary tuberculosis at the time of screening;
- Having received any vaccination within 4 weeks prior to screening;
- Positive result of blood pregnancy test;
- A confirmed diagnosis of malignant diseases such as tumors prior to screening;
- Participation in other clinical trials within 3 months prior to enrollment;
- Other circumstances that the investigator deems inappropriate for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, 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, 5 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, 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.