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New treatment option for Systemic Lupus Erythematosus
Official title A Clinical Study of CD19 Universal CAR-γδT Cells in Active Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT06106893
What this study is testing
What is CD19 Universal CAR-γδ T Cells?
CD19 Universal CAR-γδ T Cells 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 CD19 Universal CAR-γδT cells in active severe systemic lupus erythematosus.
- Phase 2: a mid-size study of how well it works
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 guardians understand and voluntarily sign the informed consent form, and be able to complete all the documents, procedures...
- Age range from 18 to 70 years old, regardless of gender;
- Body weight ≥ 40kg;
- Participants diagnosed with SLE according to the American College of Rheumatology (ACR) 1997 revised criteria for SLE at least 24 weeks prior to...
- active SLE needs to meet the following criteria at screening: SELENA-SLEDAI score ≥ 6 points; PGA ≥ 1 points;
You likely can't join if
- Known hypersensitivity to prednisone, immunosuppressive agents;
- Diagnosis of active severe lupus nephritis within 8 weeks prior to screening, requiring medications prohibited by the research protocol for active...
- Suicidal ideation within the past 6 months based on assessment by Columbia-Suicide Severity Rating Scale (C-SSRS) at screening; or any suicidal...
- Presence of SLE or non-SLE related central nervous system diseases or pathological changes within 8 weeks prior to screening;
- Existence of other lupus crisis within 8 weeks prior to screening;
- Previous or current diagnosis of non-SLE-related inflammatory arthropathy or skin diseases;
See the full eligibility criteria
- Participants or their 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 protocol...
- Age range from 18 to 70 years old, regardless of gender;
- Body weight ≥ 40kg;
- Participants diagnosed with SLE according to the American College of Rheumatology (ACR) 1997 revised criteria for SLE at least 24 weeks prior to signing the informed consent form;
- active SLE needs to meet the following criteria at screening: SELENA-SLEDAI score ≥ 6 points; PGA ≥ 1 points;
- Have received at least 8 weeks of standardized treatment for SLE prior to screening;
- Female participants need to have a negative pregnancy test, and participants agree to take effective contraceptive measures throughout the study.
- Known hypersensitivity to prednisone, immunosuppressive agents;
- 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...
- Suicidal ideation within the past 6 months based on assessment by Columbia-Suicide Severity Rating Scale (C-SSRS) at screening; or any suicidal behaviors within the past 12 months or recurrent suicidal behaviors during...
- Presence of SLE or non-SLE related central nervous system diseases or pathological changes within 8 weeks prior to screening;
- Existence of other lupus crisis within 8 weeks prior to screening;
- Previous or current diagnosis of non-SLE-related inflammatory arthropathy or skin diseases;
- Previous or current diagnosis of severe vasculitis due to other diseases excluding SLE;
- History of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation;
- Have received plasmapheresis, hemodialysis, intravenous immunoglobulin within 14 days prior to screening;
- Other autoimmune diseases requiring systemic therapy;
- Active or latent tuberculosis at screening (can be enrolled if appropriately treated);
- Any of severe laboratory abnormalities in liver function, renal function, bone marrow function, coagulation function, pulmonary function, cardiac function at screening;
- History of severe allergy or known hypersensitivity to any of the active ingredients of the drugs, excipients, or rodent-derived products, xenoproteins included in this trial, or people with allergic constitution;
- Severe heart diseases;
- Severe hepatobiliary disease;
- Presence of medical conditions that are obviously unstable or not effectively treated;
- Presence of uncontrollable bacterial, fungal, viral or other infections, 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 any commercially available Janus kinase inhibitor or Bruton tyrosine kinase inhibitor within 3 half-lives 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;
- Previous 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 undergone major surgery within 4 weeks prior to lymph depletion or those who are scheduled to undergo major surgery during the study period, or whose surgical wounds have not fully healed prior to...
- people that have donated blood for ≥ 400mL or had significant blood loss equivalent to at least 400mL within 4 weeks prior to screening, or have received a 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 with severe mental illness;
- Alcoholics or people with a history of drug abuse;
- Female people who are pregnant or lactating, or intend to pursue pregnancy within 2 years after the cell infusion; male patients whose female sexual partners intend to conceive within 2 years after the cell infusion;
- History of malignancy；
- Patients that have contraindications to any of the study procedures or have other medical conditions that may expose them to unacceptable risk, in the judgment of the investigators and/or clinical criteria.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, 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, Hubei, 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.