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COMparison of B-cell dePletion by rituximAb and anti-CD 19 CAR-T therapy in patients with rhEumatoid arthritis- The COMPARE TRIAL
EU CTIS ID: 2024-514955-13-00
What this study is testing
Primary objective phase I: To assess the safety of anti-CD19 CAR T cell therapy in subjects with active, ACPA positive and treatment refractory RA Co-Primary objective phase II: To assess the safety of anti-CD19 CAR T cell therapy and of rituximab in subjects with active, ACPA positive and treatment refractory RA Co-Primary objective phase II: To assess ACPA seroconversion after anti-CD19 CAR T cell or rituximab therapy in subjects with active, ACPA positive and treatment refractory RA
- 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
- 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 seum 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
- Male or female, age ≥ 18 and ≤ 80 years at time of consent
- Able to adhere to the study visits and protocol
You likely can't join if
- ANC < 1.000/mm3, ALC < 500/mm3 or hemoglobin < 8g/dl, absolute CD3+T cell count < 100/µl
- 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 period or within 14 days preceding leukapheresis
- 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 (according to § 40 Abs. 4 and § 41 Abs. 2 and Abs. 3 AMG)
See the full eligibility criteria
- Understand and voluntarily sign an informed consent form
- 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 seum 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
- 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
- ANC < 1.000/mm3, ALC < 500/mm3 or hemoglobin < 8g/dl, absolute CD3+T cell count < 100/µl
- 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 period or within 14 days preceding leukapheresis
- 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 (according 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 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).
- 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 B or C), heart and pulmonary (NYHA IIIIV, blood oxygenation <92%) 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 antibody therapy, adoptive T cell therapy or any prior gene therapy product (e.g. CAR T cell therapy)
- Only in phase II: Prior treatment of rituximab < 7 months before baseline OR ≥ 7 months before baseline) and B cell level < 0.1/nl
- History of bone marrow/ hematopoietic stem cell or solid organ transplantation
- 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 positive Quantiferon TB-test. If presence of latent tuberculosis is estab-lished then treatment according to local guidelines must have been initiated prior to enrollment
- Pregnant or lactating females
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.