Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-24 @ 1:57 PM
NCT ID:
NCT06475495
Eligibility Criteria:
Main Inclusion Criteria:
* Understand and voluntarily sign an informed consent form
* Male or female, age ≥ 18 and ≤ 80 years at time of consent
* Able to adhere to the study visits and protocol
* Fulfilment of the 2010 ACR-EULAR RA classification criteria
* ACPA positivity (cut off 20 mU/ml) at screening
* Disease Activity Score DAS28-ESR\>3.2 at screening
* Failure (defined as inadequate response after at least 3 months of therapy) of at least one conventional DMARD and at least two tsDMARD/bDMARDs
* At least one swollen joint with Power Doppler activity of at least grade 1 or B-mode activity of at least grade 2 at screening
* Willingness to participate in a synovial puncture and biopsy
* Male subjects unless surgically sterile, must agree to use two accepta-ble 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 or rituximab
* Females of childbearing potential (FCBP) must have a negative serum pregnancy test at screening and must agree to use a highly effective contraceptive method (Pearl index \<1) starting from the time of signing the ICF and for 12 months after dosing of the IMP or rituximab
* Updated vaccination record according to the STIKO recommendations for immunocompromised patients
Main Exclusion Criteria:
* ANC \< 1.000/mm3, ALC \< 500/mm3 or hemoglobin \< 8g/dl, absolute CD3+T cell count \< 100/µl
* Severely impaired renal (eGFR ≤ 30 ml/min/m2), liver (Child Pugh B or C), or heart andor pulmonary (NYHA III or IV, blood oxygenation \<92%) function
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to partici-pate in the study or confounds the ability to interpret data from the study
* Prior treatment with anti-CD19 antibody therapy, adoptive T cell thera-py or any prior gene therapy product (e.g. CAR T cell therapy)
* Only in phase II: Prior treatment of rituximab \< 7 months before base-line OR ≥ 7 months before baseline and B cell level \< 0.1/nl
* History of bone marrow/ hematopoietic stem cell or solid organ trans-plantation
* csDMARD other than MTX at baseline
* Any concomitant severe active infection, e.g. HIV, hepatitis B or C, SARS-CoV-2 (COVID-19), or active tuberculosis as defined by a posi-tive Quantiferon TB-test. If presence of latent tuberculosis is estab-lished then treatment according to local guidelines must have been ini-tiated prior to enrollment
* 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 (except basal or squamous cell skin cancer)
* Requirement for immunization with live vaccine during the study peri-od or within 14 days preceding leukapheresis,
* Subjects who are younger than 18 years or are incapable to under-stand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 and Abs. 3 AMG),
* Subject who Hhave a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the Investigator, may in-crease the risks associated with study participation or study agent ad-ministration, or may interfere with interpretation of results,
* Subjects who possibly are dependent on the Sponsor, the Principal In-vestigator or Investigator (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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06475495
Study Brief:
Protocol Section:
NCT06475495