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COMPARE TRIAL: Rituximab vs anti-CD19 CAR-T in refractory rheumatoid arthritis
2024-514955-13-00Phase 2Authorised
- Sponsor
- Charité – Universitätsmedizin Berlin
- Start
- Nov 2024
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies
- Countries
- 1
01
Overview
Phase 2, randomised, open-label trial in rheumatoid arthritis (RA) comparing KYV-101 anti-CD19 CAR-T cell therapy with Rituximab (Rixathon) control (2 arms). Primary endpoints: Safety (Phase I): Incidence and grading of CRS and ICANS and AE/SAE due to IMP within first 4 weeks, Safety (Phase II): AE and SAE due to IMP and rituximab and 1 more. Planned start Nov 2024; status: authorised.
02
Drugs
mivocabtagene autoleucelrituximab
03
Conditions
rheumatoid arthritis (RA)
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