BridgeMD
New treatment option for Systemic Lupus Erythematosus (SLE)
Official title A Clinical Study of Dual-Target, Universal CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT07444307
What this study is testing
What is QT-019B Cell Injection?
QT-019B Cell Injection is an investigational medicine, being studied as a potential treatment for systemic lupus erythematosus (sle).
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 study is a single-arm, open-label clinical study designed to evaluate the safety and tolerability of QT-019B in subjects with refractory SLE and to determine the RD. The study has two phases: dose escalation and dose expansion, with a planned enrollment of 18-24 subjects.
- 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 18 to 65
You may be able to join if
- 1\. Age ≥18 years and ≤65 years at screening, gender is not limited.
- 2\. people diagnosed with systemic lupus erythematosus according to the 2019 European League Against Rheumatism/American College of Rheumatology...
- 3\. Meets the criteria for refractory SLE: a) Must have received adequate standard treatment prior to screening, including glucocorticoids...
- 4\. Positive serological test during the screening period, for at least one of the following autoantibodies: antinuclear antibodies (ANA) at a titer...
- 5\. At screening: a) SLE with or without Lupus Nephritis with SLEDAI-2K≥6. b) Severe, refractory SLE-ITP which is characterized by platelet count \<...
You likely can't join if
- 1\. Presence or definite history of central nervous system disorders, such as seizures, epilepsy, cerebrovascular accident (ischemic/hemorrhagic)...
- 2\. Need for hemodialysis or high-dose corticosteroid therapy (prednisone ≥1.5 mg/kg/day or equivalent corticosteroid therapy ≥14 days) within 2...
- 3\. A large amount of serous cavity effusion with compressive symptoms that cannot be controlled after treatment (such as pleural effusion, ascites).
- 4\. In the two years prior to the screening, people with other active autoimmune diseases (such as Crohn's disease or rheumatoid arthritis), except...
- 5\. Hematopoietic dysfunction that does not fulfill the criteria for SLE and its related ITP as determined by a bone marrow aspirate and/or biopsy...
- 6\. people who have previously received gene-modified cell therapy, such as TCR-T, CAR-T, CAR-NK cells, and others.
See the full eligibility criteria
- 1\. Age ≥18 years and ≤65 years at screening, gender is not limited.
- 2\. people diagnosed with systemic lupus erythematosus according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria.
- 3\. Meets the criteria for refractory SLE: a) Must have received adequate standard treatment prior to screening, including glucocorticoids, immunosuppressants, biologics. b) Refractory SLE is defined as a failure to...
- 4\. Positive serological test during the screening period, for at least one of the following autoantibodies: antinuclear antibodies (ANA) at a titer of ≥1:80, or anti dsDNA (above the ULN), or anti-Sm (above the ULN)...
- 5\. At screening: a) SLE with or without Lupus Nephritis with SLEDAI-2K≥6. b) Severe, refractory SLE-ITP which is characterized by platelet count \< 30×109/L, or \< 50×109/L accompanied by a bleeding tendency.
- 6\. Important organ functions during the screening period must meet the following requirements (excluding abnormalities related to SLE): a) Bone marrow function must meet the following: a. Neutrophil count ≥0.5×109/L...
- 7\. Female people of childbearing potential and male people whose partners are women of childbearing potential must use medically approved contraceptive measures or abstain from sex during the study treatment period and...
- 8\. Voluntarily participate in this clinical study, sign the informed consent form, have good compliance, and cooperate with follow-up.
- 1\. Presence or definite history of central nervous system disorders, such as seizures, epilepsy, cerebrovascular accident (ischemic/hemorrhagic), cerebral edema, paralysis, aphasia, severe brain injury, dementia...
- 2\. Need for hemodialysis or high-dose corticosteroid therapy (prednisone ≥1.5 mg/kg/day or equivalent corticosteroid therapy ≥14 days) within 2 months before screening.
- 3\. A large amount of serous cavity effusion with compressive symptoms that cannot be controlled after treatment (such as pleural effusion, ascites).
- 4\. In the two years prior to the screening, people with other active autoimmune diseases (such as Crohn's disease or rheumatoid arthritis), except for SLE and its related conditions (such as SLE-induced...
- 5\. Hematopoietic dysfunction that does not fulfill the criteria for SLE and its related ITP as determined by a bone marrow aspirate and/or biopsy, or people who have received or are waiting for hematopoietic stem...
- 6\. people who have previously received gene-modified cell therapy, such as TCR-T, CAR-T, CAR-NK cells, and others.
- 7\. people who have used any other investigational drug for SLE within 4 weeks prior to screening.
- 8\. people with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer above the upper limit of detection, people with positive hepatitis C virus (HCV)...
- 9\. Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg) within one month prior to screening, or any other serious cardiovascular diseases that could present...
- 10\. A documented history of symptomatic deep vein thrombosis or pulmonary embolism within six months prior to the screening, or the presence of clinically significant pleural effusion, or an oxygen saturation level...
- 11\. History of treated or untreated malignancy of any organ system within 5 years prior to screening (excluding basal cell carcinoma of the skin, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast...
- 12\. Participants with any active infection, and any infection requiring systemic antimicrobial therapy within the past 30 days.
- 13\. Any additional factors that the investigator thinks could put the people at risk, affect their adherence to treatment, disrupt the study's execution, or influence the study results.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Wuhan, Hubei, 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, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Wuhan, Hubei, 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.