CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases (NCT07596680) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases
China30 participantsStarted 2026-04-30
Plain-language summary
This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune diseases. The enrolled population consists of patients with active autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), ANCA-associated vasculitis (AAV), idiopathic inflammatory myopathies (IIM), Sjögren's syndrome (SS), among others.
The CAR-T cell dose used in this study is 6×10⁶ CAR⁺ T cells/kg. Six subjects will be enrolled for each indication, with a total of 30 subjects to be enrolled.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. General Inclusion Criteria (All Patients)
. Voluntarily provides written informed consent.
. Age ≥18 and ≤70 years, any gender.
. Adequate organ function:
. Negative serum or urine pregnancy test for females of childbearing potential at screening.
. Highly effective contraception required from 28 days before lymphodepletion until 12 months after RD06-05 infusion for females; effective barrier contraception required from lymphodepletion until 12 months after RD06-05 infusion for males, with no sperm donation during the study.
. For SLE Patients
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is using something called 'universal' CAR-T cells — meaning they come from a donor rather than from my own body — so how does that approach change the risks compared to the CAR-T therapies I may have read about, and what is my doctor's honest assessment of what is and isn't yet known about its safety?
2Since this is an early Phase 1 trial that hasn't even started recruiting yet, does my doctor think waiting for more safety and dosing data from this study to mature makes sense, or is my current condition serious enough that I should be exploring available treatment options right now?
3CAR-T cell therapy typically requires significant preparation steps like lymphodepletion chemotherapy and close monitoring afterward — given my specific diagnosis and overall health, does my doctor think my body could realistically handle that kind of intensive treatment process?
4Because this trial is studying several different autoimmune diseases at once, would my doctor expect the findings most relevant to my specific condition — whether that's lupus, systemic sclerosis, vasculitis, myositis, or Sjögren's — to be clearly separated out, and how confident are they that the results would be meaningful for someone like me?
5Before even considering a trial like this, are there standard-of-care treatments or other approved therapies my doctor would recommend I try first, and what would need to happen — or not happen — with those options before a Phase 1 CAR-T trial would make sense to revisit?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.