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New treatment option for Systemic Lupus Erythematosus
Official title CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease
ClinicalTrials.gov ID: NCT06347718
What this study is testing
What is anti-CD19 CAR T cell therapy?
anti-CD19 CAR T cell therapy is an investigational medicine, 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 investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors.
- 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 and older
You may be able to join if
- General:
- people must understand and voluntarily sign an informed consent form including written consent for data protection,
- Adults aged ≥ 18 years at time of consent,
- Adequate renal (eGFR \> 30 ml/min/m2), liver (no Child Pugh C), heart (at worst NYHA III, EF \> 30%) and pulmonary (FV and DLCO \> 30%) function,
- Male people unless surgically sterile, must agree to use two acceptable methods for contraception (e.g. spermicide and condom) during the trial and...
You likely can't join if
- Clinically suitability for a less burdensome and/or approved therapeutic approach, as judged by the investigator
- ANC \< 1.000/mm3, ALC \< 500/mm3 or hemoglobin \< 8g/dl, absolute CD3+ T cell count \< 100/μl,
- Uncontrolled severe concomitant disease, such as cancer (except basal or squamous cell skin cancer) and diabetes mellitus,
- Severely impaired renal (eGFR ≤ 30 ml/min/m2), liver (Child Pugh C), heart (NYHA IV, EF ≤ 30%) and pulmonary (FV and DLCO ≤ 30%) function,
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if the subject were to participate...
- Prior treatment with anti-CD19 antibody therapy, adoptive T cell therapy or any prior gene therapy product (e.g. CAR T cell therapy),
See the full eligibility criteria
Who can join
- General:
- people must understand and voluntarily sign an informed consent form including written consent for data protection,
- Adults aged ≥ 18 years at time of consent,
- Adequate renal (eGFR \> 30 ml/min/m2), liver (no Child Pugh C), heart (at worst NYHA III, EF \> 30%) and pulmonary (FV and DLCO \> 30%) function,
- Male people unless surgically sterile, must agree to use two acceptable methods for contraception (e.g. spermicide and condom) during the trial and refrain from fathering a child starting from the time of signing the...
- Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening and must agree to use a highly effective contraceptive method (Pearl in-dex \<1) starting from the time of signing the ICF...
- Must be able to adhere to the study visit schedule and other protocol requirements,
- Double vaccination against SARS-CoV-2 or SARS-CoV-2 within the last 6 months.
- SLE specific:
- Fulfilling the 2019 ACR/EULAR classification criteria of SLE,
- Positivity of anti-dsDNA (\> 4 U/l), anti-histone (+ or more), anti-nucleosome (+ or more) or anti-Sm antibodies (+ or more),
- Active disease at screening, defined as ≥ 1 organ system with a British Isles Lupus Assessment (BILAG) A score (severe disease activity) or ≥ 2 organ systems with a BILAG B score (moderate disease activity),
- Insufficient response or intolerance/ contraindication to glucocorticoids and to at least 2 of the following treatments: hydroxychloroquine, mycophenolate mofetil, belimumab, methotrexate, rituximab, cyclophosphamide...
- SSc specific:
- Fulfilling the 2013 ACR/EULAR classification criteria of SSc),
- Positivity (+ or more) for at least one SSc-specific parameter (Scl70, RNA polymerase, Th/To, RP11/12, U3RNP autoantibodies),
- Signs for fast progression including (i) disease duration ≤ 5 years (from onset of first non-Raynaud manifestation), (ii) mRSS score 10-35 at screening, (iii) elevated acute phase reactant levels (CRP ≥ 6 mg/L, ESR ≥...
- Insufficient response or intolerance/ contraindication to at least 2 of the following treatments: mycophenolate mofetil, azathioprine, nintedanib, methotrexate, rituximab. Insufficient response is defined as having...
- DM/PM specific:
- Fulfilling the 2017 ACR/EULAR classification criteria for probable or definite DM or PM,
- Presence of active myositis in muscle biopsy or muscle MRI and/or signs of interstitial lung disease related to DM/PM,
- Positivity (+ or more) for at least one myositis-specific antibody (aminoacyl tRNA synthetases, Mi2, MDA5, SAE, SRP, ARS, HMGCR, MJ, TIF1gamma),
- Muscle weakness as define by MMT \ 0.25, at least one muscle enzyme \> 1.3 times upper limit of normal, VAS global extra muscular activity ≥ 2cm,
- Insufficient response or intolerance/ contraindication to glucocorticoids and to at least 2 of the following treatments: mycophenolate mofetil, ciclosporin A, tacrolimus, methotrexate, rituximab, intravenous...
What rules you out
- Clinically suitability for a less burdensome and/or approved therapeutic approach, as judged by the investigator
- ANC \< 1.000/mm3, ALC \< 500/mm3 or hemoglobin \< 8g/dl, absolute CD3+ T cell count \< 100/μl,
- Uncontrolled severe concomitant disease, such as cancer (except basal or squamous cell skin cancer) and diabetes mellitus,
- Severely impaired renal (eGFR ≤ 30 ml/min/m2), liver (Child Pugh C), heart (NYHA IV, EF ≤ 30%) and pulmonary (FV and DLCO ≤ 30%) function,
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if the subject were to participate in the study or confounds the ability to interpret data from the study,
- Prior treatment with anti-CD19 antibody therapy, adoptive T cell therapy or any prior gene therapy product (e.g. CAR T cell therapy),
- History of bone marrow/ hematopoietic stem cell or solid organ transplantation,
- Any concomitant severe active infection, e.g. HIV, hepatitis B or C, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon TB-test. If presence of latent tuberculosis is established then...
- Diagnosis of severe neuropsychiatric SLE, inclusion body myositis or limited SSc,
- Pregnant or lactating females,
- Females who are intending to conceive during the study,
- Known hypersensitivity to any drug components,
- Malignancy in the last 5 years before screening,
- Requirement for immunization with live vaccine during the study period or within 14 days preceding leukapheresis,
- people who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent,
- Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the Investigator, may increase the risks associated with study participation or study agent administration, or may...
- people who possibly are dependent on the Sponsor, the Principal Investigator or other Investigators (e.g. family members).
The study team makes the final eligibility decision.
Where it's taking place
- Erlangen, Bavaria, Germany
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Erlangen, Bavaria, Germany. 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.