System Lupus Erythematosus study: BCT301
Official title Clinical Study of BCT301 Cell Injection Therapy for Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT07301164
What this study is testing
What is BCT301?
BCT301 is an investigational cell therapy being studied for the treatment of System 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 study wants to see if BCT301 is safe and how much of it people can tolerate. It also looks at whether the treatment helps and how the cells behave in the body.
- Who it's for
- It is looking for adults who have autoimmune diseases that have not responded well to other treatments, such as lupus, scleroderma, myositis, antiphospholipid syndrome, ANCA‑associated vasculitis, or Sjögren syndrome.
- What's involved
- Participants will receive injections of BCT301 cells. They will have regular visits for blood tests, safety checks, and monitoring of how the cells work in their bodies.
- Time commitment
- The study lasts several weeks to months, with multiple clinic visits for injections, blood draws, and safety monitoring.
- 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 80
You may be able to join if
- General 1. Voluntarily sign the informed consent form.
- Male or female, aged 18-80 years (inclusive), with a body weight ≥40 kg.
- Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved...
- If the participant is receiving glucocorticoid therapy, the following conditions must be met: the maximum dose at screening and during the screening...
- If the participant is receiving antimalarials and/or conventional immunosuppressants: the treatment must have been initiated ≥12 weeks prior to...
You likely can't join if
- Any medical condition that, in the opinion of the investigator, would contraindicate participation in the study, such as a life-threatening illness.
- Decreased organ function reserve not attributable to the primary disease: a) Neutrophil count \ 3 × upper limit of normal (ULN)
- History of alcohol or substance abuse within the past 24 weeks.
- History of malignancy other than B-cell lymphoma.
- Presence of infections including human immunodeficiency virus (HIV), hypogammaglobulinemia, T-cell deficiency, syphilis, chronic hepatitis B or C, or...
- Known active tuberculosis (TB) infection or active bacterial infection.
See the full eligibility criteria
Who can join
- General 1. Voluntarily sign the informed consent form.
- Male or female, aged 18-80 years (inclusive), with a body weight ≥40 kg.
- Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved contraceptive methods or practice abstinence during the treatment period and...
- If the participant is receiving glucocorticoid therapy, the following conditions must be met: the maximum dose at screening and during the screening period is 30 mg/day of prednisone (or equivalent).
- If the participant is receiving antimalarials and/or conventional immunosuppressants: the treatment must have been initiated ≥12 weeks prior to screening.
- If biological agents (belimumab, telitacicept, rituximab, etc.) were used prior to the screening period, a washout period of at least 5 half-lives must be completed before screening.
- Peripheral blood B cells must show positive CD19 expression as detected by flow cytometry. Disease-Specific 1\. Systemic Lupus Erythematosus (SLE)
- Meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE.
- Have moderate to severe disease activity at screening, with a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) score \>6.
- Have inadequate response to conventional therapy or experience disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents...
- Have positive serological autoantibody tests: positive antinuclear antibodies (ANAs) and/or anti-ds-DNA antibodies and/or anti-Sm antibodies. 2\. Systemic Sclerosis (SSc)
- Meet the 2013 EULAR/ACR classification criteria for SSc.
- Inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6...
- Disease progression: skin progression with a modified Rodnan Skin Score (mRSS) ≥10; and/or interstitial lung disease evidenced by ground-glass opacities on high-resolution computed tomography (HRCT)
- Receiving standard treatment with warfarin or alternative vitamin K antagonists (maintaining target international normalized ratio [INR]), or standard therapeutic doses of low molecular weight heparin (LMWH), and/or...
- Meet all four criteria for catastrophic APS: i) Involvement of three or more organs, systems, and/or tissues; ii) Development of manifestations within one week
- Meet the 2017 EULAR/ACR classification criteria for inflammatory myopathy (including dermatomyositis, polymyositis, anti-synthetase syndrome, and immune-mediated necrotizing myopathy).
- Have positive myositis-specific autoantibodies.
- For participants with muscle involvement: a Manual Muscle Test-8 (MMT-8) score \<142, and at least two of the following five core abnormalities: Physician Global Assessment ≥2, Patient Global Assessment ≥2, or...
- Meet the 2016 ACR/EULAR classification criteria for Sjögren's syndrome.
- Have a EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥5.
- Have positive anti-SSA/Ro antibodies.
- Have inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at...
- Meet the 2022 ACR/EULAR classification criteria for ANCA-associated vasculitis (AAV), including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.
- Have a history of or currently positive ANCA.
- Have a Birmingham Vasculitis Activity Score (BVAS) ≥15 (total score 63).
- Have inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at...
What rules you out
- Any medical condition that, in the opinion of the investigator, would contraindicate participation in the study, such as a life-threatening illness.
- Decreased organ function reserve not attributable to the primary disease: a) Neutrophil count \ 3 × upper limit of normal (ULN); aspartate aminotransferase (AST) \>3 × ULN; total bilirubin \>2 × ULN
- History of alcohol or substance abuse within the past 24 weeks.
- History of malignancy other than B-cell lymphoma.
- Presence of infections including human immunodeficiency virus (HIV), hypogammaglobulinemia, T-cell deficiency, syphilis, chronic hepatitis B or C, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Known active tuberculosis (TB) infection or active bacterial infection.
- History of myocardial infarction, coronary angioplasty or stenting, unstable angina, clinically significant arrhythmia, or other clinically significant cardiac disease within 6 months prior to screening.
- Symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening, except in cases of antiphospholipid syndrome (APS).
- History of severe allergic reaction to any component of cellular therapy or other immunotherapeutic agents.
- Prior organ transplant requiring ongoing immunosuppressive therapy.
- Concurrent participation in another clinical trial that may interfere with disease assessment or study treatment.
- Prior treatment with CD19- and/or BCMA-targeted therapy or any CAR-T cell product; except in cases where prior therapy is deemed to have clearly failed (e.g., no response, short duration of response, or disease...
- Severe psychiatric disorder or significant cognitive impairment.
- Pregnancy, lactation, or planned pregnancy.
- Any other condition that, in the judgment of the investigator, would make the participant unsuitable for enrollment in this clinical trial.
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Beijing, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.