A study to assess safety, cellular kinetics and exploratory efficacy of rapcabtagene autoleucel in rheumatoid arthritis and Sjogren’s disease

Phase 1/2

Recruiting

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

Brief Summary: To assess safety of rapcabtagene autoleucel (XX) in participants with D2T RA and srSjD with organ involvement.

Recruitment & Eligibility

Inclusion Criteria

Signed informed consent must be obtained prior to participation in the study

Men and women aged ≥ 18 years and ≤ 65 years at screening

D2T RA: Diagnosis of rheumatoid arthritis

D2T RA: XX

D2T RA: Treatment failure of standard of care therapies

D2T RA: Signs suggestive of active, progressive disease

srSjD: Diagnosis of Sjogren’s disease

srSjD: XX

srSjD: Severe systemic, refractory disease with moderate to high disease activity

Exclusion Criteria

BMI at screening of ≤18.5 or ≥35 kg/m2

Any psychiatric condition or disability making compliance with treatment or informed consent impossible

Any patients requiring medications prohibited by the protocol

Any XX that needs immediate treatment other than XX impossible

Clinically significant active, opportunistic, chronic or recurrent infection

Sexually active males unwilling to use a condom during intercourse from the time enrollment

Women of childbearing potential, unless they are using a highly effective method of contraception starting from the time of enrollment

Female participants who are pregnant, breastfeeding or intending to conceive during the course of the study

Inadequate organ function during screening

History of lymphoproliferative disease or any known malignancy or history of malignancy

History of bone marrow/hematopoietic stem cell or solid organ transplantation

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations (13): Centre Hospitalier Universitaire De Bordeaux
🇫🇷
Bordeaux, France
Assistance Publique Hopitaux De Paris
🇫🇷
Le Kremlin-Bicetre, France
Centre Hospitalier Regional Et Universitaire De Brest
🇫🇷
Brest, France
Institut Gustave Roussy
🇫🇷
Villejuif, France
Centre Hospitalier Universitaire De Montpellier
🇫🇷
Montpellier Cedex 5, France
Centre Hospitalier Universitaire De Lille
🇫🇷
Lille, France
Charite Universitaetsmedizin Berlin KöR
🇩🇪
Berlin, Germany
Universitaetsklinikum Ulm AöR
🇩🇪
Ulm, Germany
University Hospital Cologne AöR
🇩🇪
Cologne, Germany
Medical Center - University Of Freiburg
🇩🇪
Freiburg Im Breisgau, Germany
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Centre Hospitalier Universitaire De Bordeaux
🇫🇷Bordeaux, France
Christophe RICHEZ
Site contact
33556795679
christophe.richez@chu-bordeaux.fr