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A phase I/II study of CAR-expressing Allogenic iPSC derived NK cells for treatment of autoiMmune disease by B cELl depletion - CARAMEL
EU CTIS ID: 2024-519532-16-00
What this study is testing
To assess the safety of CNTY-101 in subjects with active B-cell driven autoimmune disease (SLE, SSC and IIM)
- 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
- Fulfilling the 2019 ACR/EULAR classification criteria of SLE
- Presence of active myositis in muscle biopsy or muscle imaging and/or signs of interstitial lung disease related to IIM
- Positivity (+ or more) for at least one myositis-specific antibody (aminoacyl tRNA synthetases, Mi2, MDA5, SAE, SRP, ARS, HMGCR, MJ, TIF1gamma) at screening or documented medical history. Patients with positivity for TIF1gamma must have undergone a sufficient cancer screening prior screening.
- In patients with active myositis and muscle weakness: Muscle weakness as defined by MMT<142 and 2 of the following criteria: i) VAS patients global ≥2cm; ii) VAS physician global ≥2cm; iii) HAQ >0.25; iv) minimum of one muscle enzyme >1.3 times upper limit of normal; v) 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 immunoglobulins, azathioprine, cyclophosphamide or JAKi; insufficient response is defined as having increased disease activity based on the definition explained in the previous bullet point
- Positivity of anti-dsDNA (>4U/L), anti-histone (+ or more), anti-nucleosome (+ or more) or anti-Sm antibodies (+ or more) at screening or documented medical history
You likely can't join if
- Uncontrolled severe concomitant disease, such as cancer (except basal or squamous cell skin cancer), diabetes mellitus or severe hepatic insufficiency defined as Child Pugh score ≥ 10 (C) or unstable coronary artery disease
- Malignancy in the last 5 years before screening, except localized basal cell or squamous skin carcinoma, treated curatively and without evidence of recurrence. In situ carcinoma of the cervix or breast within the past 3 years is also allowed if treated curatively and without evidence of recurrence
- Requirement for immunization with live vaccine during the study period or within 14 days preceding LDC
- Subjects 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 interfere with interpretation of results
- Subjects who possibly are dependent on the Sponsor, the Principal Investigator or Investigator (e.g., family members)
See the full eligibility criteria
Who can join
- Fulfilling the 2019 ACR/EULAR classification criteria of SLE
- Presence of active myositis in muscle biopsy or muscle imaging and/or signs of interstitial lung disease related to IIM
- Positivity (+ or more) for at least one myositis-specific antibody (aminoacyl tRNA synthetases, Mi2, MDA5, SAE, SRP, ARS, HMGCR, MJ, TIF1gamma) at screening or documented medical history. Patients with positivity for TIF1gamma must have undergone a sufficient cancer screening prior screening.
- In patients with active myositis and muscle weakness: Muscle weakness as defined by MMT<142 and 2 of the following criteria: i) VAS patients global ≥2cm; ii) VAS physician global ≥2cm; iii) HAQ >0.25; iv) minimum of one muscle enzyme >1.3 times upper limit of normal; v) 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 immunoglobulins, azathioprine, cyclophosphamide or JAKi; insufficient response is defined as having increased disease activity based on the definition explained in the previous bullet point
- Positivity of anti-dsDNA (>4U/L), anti-histone (+ or more), anti-nucleosome (+ or more) or anti-Sm antibodies (+ or more) at screening or documented medical history
- 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: azathioprine, mycophenolate mofetil, belimumab, methotrexate, rituximab, obinutuzumab, anifrolumab, cyclophosphamide; insufficient response is defined as having increased disease activity based on the definition explained in the previous bullet point
- Fulfilling the 2013 ACR/EULAR classification criteria of SSc
- Diffuse SSc with positivity (+ or more) of either Scl70, RNA polymerase, Th/To, RP11/12 or U3RNP autoantibodies at screening or documented medical history
- Signs for fast progression including (i) disease duration ≤7 5 years (from onset of first non-Raynaud manifestation), (ii) mRSS score 10-35≥ 15 at screening, (iii) elevated acute phase reactant levels (CRP ≥6 mg/L, ESR ≥28 mm/h or platelet count ≥330 G/L), (iv) mRSS increase ≥3 units or involvement of one new body area or mRSS increase ≥2 units in one body area or ≥1 tendon friction rub over 6 months
- Insufficient response or intolerance/contraindication to glucocorticoids and to at least 2 of the following treatments: mycophenolate mofetil, azathioprine, nintedanib, methotrexate, rituximab, cyclophosphamide, tocilizumab and not eligible or denying AHCT
- Fulfilling the 2017 ACR/EULAR classification criteria for probable or definite IIM
What rules you out
- Uncontrolled severe concomitant disease, such as cancer (except basal or squamous cell skin cancer), diabetes mellitus or severe hepatic insufficiency defined as Child Pugh score ≥ 10 (C) or unstable coronary artery disease
- Malignancy in the last 5 years before screening, except localized basal cell or squamous skin carcinoma, treated curatively and without evidence of recurrence. In situ carcinoma of the cervix or breast within the past 3 years is also allowed if treated curatively and without evidence of recurrence
- Requirement for immunization with live vaccine during the study period or within 14 days preceding LDC
- Subjects 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 interfere with interpretation of results
- Subjects who possibly are dependent on the Sponsor, the Principal Investigator or Investigator (e.g., family members)
- Severely impaired renal (GFR ≤30 ml/min/1.73m2), liver (AST/ALT >3xN, Child Pugh C), heart (NYHA IV, EF <40 %) and pulmonary (FV and DLCO <30 %) function
- 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 CAR-T cell therapy
- History of allogeneic bone marrow/hematopoietic stem cell 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 guidelines must have been initiated prior to enrollment
- Diagnosis of severe neuropsychiatric SLE, inclusion body myositis or limited SSc
- Pregnant or lactating females as well as the intention to conceive during the study
- Known hypersensitivity to any drug components
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, 18-64 years, 65+ 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.