Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06475495 | Comparison of B-cell Depletion by Rituximab and Anti-CD 19 CAR-T Therapy in Patients With Rheumatoid Arthritis | PHASE1 | ACTIVE NOT_RECRUITING | 13 | — | — | Dec 4, 2024 | Jun 1, 2027 | Mar 5, 2026 | 1 | Germany |
Incidence and grading of severity (graded 0-4) of Cytokine Release Syndrome (CRS) due to IMP within the first 4 weeks after anti-CD19 CAR T cell therapy.
Incidence and grading of severity (graded 0-4) of Immune Cell Associated Neurotoxicity Syn-drome (ICANS) due to IMP within the first 4 weeks after anti-CD19 CAR T cell therapy.
Incidence and grading of severity (graded 0-4) of Adverse Events (AE) due to IMP within the first 4 weeks after anti-CD19 CAR T cell therapy.
Incidence and grading of severity (graded 0-4) of Serious Adverse Events (SAE) due to IMP within the first 4 weeks after anti-CD19 CAR T cell therapy.
Percentage of subjects with ACPA seroconversion = ACPA level \<20 mU/ml at week 16.
AE due to IMP and rituximab throughout the whole study
SAE due to IMP and rituximab throughout the whole study
| Arm | Type | Description |
|---|---|---|
| KYV101 | EXPERIMENTAL | Participants in this arm will receive a single dose of KYV-101 i.v., an autologous fully-human anti-CD19 CAR T-cell immunotherapy. |
| Rituximab | ACTIVE_COMPARATOR | In the Comparator group patients will receive 2x1 g Rituximab i.v. (Day 0 and Day 14). Retreatment of 1000 mg rituximab i.v. may be initiated at week 24 if residual disease activity remains, otherwise retreatment should be delayed until disease activity returns. A DAS-28-CRP \> 3.2 will be used as a non-binding guidance for the re-treatment decision. |
| Name | Type | Description |
|---|---|---|
| KYV101 | DRUG | an autologous fully-human anti-CD19 CAR T-cell immunotherapy |
| Rituximab (active comparator) | DRUG | anti CD20 monoclonal antibody |
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 sc...