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Anti-CD 19 CAR-T cell therapy in patients with ANCA Vasculitis - the IDEAL trial
EU CTIS ID: 2024-517303-36-00
What this study is testing
primary objective phase I: To assess the safety of anti-CD19 CAR T cell therapy in subjects with active, treatment re-fractory, ANCA-IgG-positive AAV Co-Primary objectives phase II: To assess the safety of anti-CD19 CAR T cell therapy in subjects with active, treatment re-fractory ANCA-IgG-positive AAV Co-Primary objectives phase II: To assess the ANCA seroconversion rate in subjects with active, treatment refractory ANCA-IgG-positive AAV
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Understand and voluntarily sign an informed consent form
- Additional criteria before leukapheresis: no evidence of a clinically significant active infection
- Additional criteria before leukapheresis: negative urine pregnancy test in female patients
- Additional criteria before leukapheresis: no clinically relevant abnormal findings on brain MRI, EEG, Echocardiogram or lung function test which would put the subject at undue risk when participating in this study
- Additional criteria before lymphodepletion: no evidence of a clinically significant active infection
- Additional criteria before lymphodepletion: eGFR > 30 ml/min/m2
You likely can't join if
- ANC < 500/µl, ALC < 100/µl or hemoglobin < 8g/dl, absolute CD3+T cell count < 100/µl at screening
- Known hypersensitivity to any drug components
- Malignancy in the last 5 years before screening (except adequately treated basal or squamous cell skin cancer)
- Requirement for immunization with live vaccine during the study period or within 14 days preceding leukapheresis,
- Subjects who are younger than 18 years or are incapable to understand the aim, im-portance and consequences of the study and to give legal informed consent (accord-ing to § 40 Abs. 4 and § 41 Abs. 2 and Abs. 3 AMG),
- 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 participa-tion or study agent administration, or may interfere with interpretation of results,
See the full eligibility criteria
Who can join
- Understand and voluntarily sign an informed consent form
- Additional criteria before leukapheresis: no evidence of a clinically significant active infection
- Additional criteria before leukapheresis: negative urine pregnancy test in female patients
- Additional criteria before leukapheresis: no clinically relevant abnormal findings on brain MRI, EEG, Echocardiogram or lung function test which would put the subject at undue risk when participating in this study
- Additional criteria before lymphodepletion: no evidence of a clinically significant active infection
- Additional criteria before lymphodepletion: eGFR > 30 ml/min/m2
- Additional criteria before lymphodepletion: no acute central neurological toxicity
- Additional criteria before lymphodepletion: negative urine pregnancy test in female patients
- Additional criteria before lymphodepletion: notification of successful CAR T cell production by the manufacturer
- Additional criteria before IMP administration: no evidence of a clinically significant active infection
- Additional criteria before IMP administration: no acute central neurological toxicity
- Male or female, age ≥ 18 and ≤ 75 years at time of consent
- Able to adhere to the study visits and protocol
- Fulfilment of • EITHER both of the following 2022 ACR/EULAR classification criteria for granulomatosis with polyangiitis (GPA) detectable anti-PR3 antibodies (≥ 20 AU/ml in CLIA) at screening • OR both of the following 2022 ACR/EULAR classification criteria for microscopic polyangiitis (MPA) detectable anti-MPO antibodies (≥ 10 AU/ml in CLIA) at screening
- Active disease, defined as Clinical activity (BVAS ≥ 3) at screening
- Insufficient response or intolerance/contraindication to glucocorticoids and to at least one of the following treatments: rituximab, mycophenolate mofetil, azathioprine, methotrexate, cyclophosphamide, avacopan. Insufficient response is defined as hav-ing disease activity based on the definition explained in the previous bullet point
- Male subjects 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 Informed Consent Form (ICF) until 12 months after dosing of the IMP
- 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 and for 12 months after dosing of the IMP
- Updated vaccination record according to the STIKO recommendations for immuno-compromised patients
What rules you out
- ANC < 500/µl, ALC < 100/µl or hemoglobin < 8g/dl, absolute CD3+T cell count < 100/µl at screening
- Known hypersensitivity to any drug components
- Malignancy in the last 5 years before screening (except adequately treated basal or squamous cell skin cancer)
- Requirement for immunization with live vaccine during the study period or within 14 days preceding leukapheresis,
- Subjects who are younger than 18 years or are incapable to understand the aim, im-portance and consequences of the study and to give legal informed consent (accord-ing to § 40 Abs. 4 and § 41 Abs. 2 and Abs. 3 AMG),
- 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 participa-tion or study agent administration, or may interfere with interpretation of results,
- Subjects who possibly are dependent on the Sponsor, the Principal Investigator or In-vestigator (e.g. family members).
- Subjects who are institutionalized by order of court or public authority,
- Subjects participating in another clinical trial with an investigational medicinal product or medical device (3 months before this trial).
- Severely impaired renal (eGFR ≤ 30 ml/min/m2), liver (Child Pugh C), or heart or pulmonary (NYHA IV, blood oxygenation < 92%) function
- Clinically relevant rapidly progressive glomerulonephritis or pulmonary alveolar hem-orrhage
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she 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 treatment according to local guide-lines must have been initiated prior to enrollment
- Pregnant or lactating females
- Females who are intending to conceive during the study
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.