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New treatment option for Systemic Lupus Erythematosus
Official title CD19/BCMA CAR-T Cell Therapy for Refractory/Moderate-to-severe Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT06349343
What this study is testing
What is CD19/BCMA CAR-T cell therapy?
CD19/BCMA CAR-T cell therapy is an investigational medicine, given as an infusion into a vein, 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
- The purpose of the study is to explore the safety and efficacy of cluster of differentiation 19 (CD19)/B cell maturation antigen (BCMA) CAR-T cell therapy in refractory/moderate-to-severe systemic lupus erythematosus(SLE).
- 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 70
You may be able to join if
- Participants or their legal guardians understand and voluntarily sign the informed consent form, and be able to complete all the documents...
- Age range from 18 to 70 years old, regardless of gender;
- Participants diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)/the American College of Rheumatology (ACR) SLE...
- Refractory/moderate-to-severe SLE needs to meet the following criteria at screening: SELENA-SLEDAI score \> 6 points; PGA ≥ 1 points; BILAG-2004...
- Participants with fertility agree to take effective contraceptive measures throughout the study and within 3 months after the last follow-up visit.
You likely can't join if
- Diagnosis of active severe lupus nephritis within 8 weeks prior to screening, requiring medications prohibited by the research protocol for active...
- Any attempted suicide or suicidal ideation within the past year prior to screening;
- Presence of SLE or non-SLE related central nervous system diseases or pathological changes within 8 weeks prior to screening;
- Previous or current diagnosis of non-SLE-related inflammatory arthropathy or skin diseases;
- History of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation;
- History of lymphoproliferative diseases;
See the full eligibility criteria
Who can join
- Participants or their legal guardians understand and voluntarily sign the informed consent form, and be able to complete all the documents, procedures, follow-up examinations and treatments specified in the study...
- Age range from 18 to 70 years old, regardless of gender;
- Participants diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)/the American College of Rheumatology (ACR) SLE criteria at least 24 weeks prior to screening;
- Refractory/moderate-to-severe SLE needs to meet the following criteria at screening: SELENA-SLEDAI score \> 6 points; PGA ≥ 1 points; BILAG-2004 organ system scores of at least 1 A or 2 B;Have received at least 12 weeks...
- Participants with fertility agree to take effective contraceptive measures throughout the study and within 3 months after the last follow-up visit.
What rules you out
- Diagnosis of active severe lupus nephritis within 8 weeks prior to screening, requiring medications prohibited by the research protocol for active nephritis, hemodialysis or prednisone ≥ 100 mg/d, or equivalent...
- Any attempted suicide or suicidal ideation within the past year prior to screening;
- Presence of SLE or non-SLE related central nervous system diseases or pathological changes within 8 weeks prior to screening;
- Previous or current diagnosis of non-SLE-related inflammatory arthropathy or skin diseases;
- History of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation;
- History of lymphoproliferative diseases;
- people with malignancy within 5 years prior to screening;
- Have received plasma exchange, plasma separation, hemodialysis, or intravenous immunoglobulin (IVIG) within 14 days prior to screening;
- Other autoimmune diseases requiring systemic therapy;
- people with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV DNA titer in peripheral blood higher than the lower limit of research institution's test range. people with positive...
- Active or latent tuberculosis at screening;
- Abnormalities in major organ function at screening;
- Previous or current diagnosis of acute or chronic illnesses unrelated to SLE with obviously unstable or uncontrollable clinical symptoms;
- Severe lupus lung damage at screening;
- Severe lupus cardiac damage at screening;
- Presence of uncontrollable infections at screening, requiring antibiotic therapy;
- Have received live/attenuated vaccination within 4 weeks prior to screening or plan to receive live/attenuated vaccination throughout the study;
- Have received intra-articular, intramuscular or intravenous glucocorticoids within 4 weeks prior to screening;
- Have received any commercially available Janus kinase (JAK) inhibitor or Bruton tyrosine kinase (BTK) inhibitor within 12 weeks prior to screening;
- Have received B-cell targeted therapy prior to screening;
- Have received a biologic agent other than B-cell targeted therapy within 5 half-lives prior to screening;
- Previously received therapies with CAR-T cells or other genetically modified T cells;
- Have received therapeutic dose of corticosteroids within 7 days prior to leukapheresis or within 72 hours prior to infusion;
- people that have donated blood for ≥ 400mL or had a significant blood loss equivalent to at least 400mL within 4 weeks prior to screening, or have received blood transfusion within 8 weeks, or plan to donate blood...
- History of ≥grade 2 bleeding within 4 weeks prior to screening or need for long-term continuous anticoagulant therapy;
- people that have undergone any major surgeries within 12 weeks prior to screening, or those who are scheduled to undergo major surgery during the study period;
- History of drug abuse within 12 weeks prior to screening;
- Female people who are pregnant or lactating, or intend to conceive within 2 years after the cell infusion; male patients whose female partners intend to conceive within 2 years after the cell infusion;
- History of any significant drug allergy or intolerance;
- people that have participated in other clinical trials within 3 months prior to screening and/or currently participated in other clinical trials (those who do not receive study drugs are excluded);
- Presence of other circumstances that make the people not eligible for participation in the study, in the opinion of the researchers.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, 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.