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An open-label, multi-center, phase 1/2 study to assess safety, cellular kinetics and exploratory efficacy of rapcabtagene autoleucel in participants with difficult-to-treat rheumatoid arthritis and severe, refractory Sjogren's disease with organ involvement

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514596-18-00
Acronym
CYTB323M12101B
Enrollment
17
Registered
2025-05-02
Start date
2025-06-20
Completion date
Unknown
Last updated
2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult to treat rheumatoid arthritis, Severe, refractory Sjogren’s disease with organ involvement

Brief summary

Safety parameters include vital signs, adverse events, laboratory parameters and ECG evaluation

Detailed description

Rapcabtagene autoleucel transgene concentrations by qPCR over time in peripheral blood; cellular kinetics parameters (Cmax, AUC, Tmax, T1/2, Clast, Tlast)

Interventions

DRUGYTB323
DRUGCYCLOPHOSPHAMIDE
DRUGTOCILIZUMAB
DRUGFLUDARABINE PHOSPHATE

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Safety parameters include vital signs, adverse events, laboratory parameters and ECG evaluation—

Secondary

MeasureTime frame
Rapcabtagene autoleucel transgene concentrations by qPCR over time in peripheral blood; cellular kinetics parameters (Cmax, AUC, Tmax, T1/2, Clast, Tlast)—

Countries

France, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026