A Study to Assess Safety, Cellular Kinetics and Exploratory Efficacy of Rapcabtagene Autoleucel in Rheumatoid Arthritis and Sjogren's Disease

Not Applicable

Recruiting

• Conditions: Rheumatoid Arthritis (RA) and Sjögren's Disease (SjD)
• Interventions: Biological: Rapcabtagene autoleucel

• Registration Number: NCT07048197
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

The study is intended to assess safety, cellular kinetics and any early sign for efficacy of rapcabtagene autoleucel in participants with difficult-to-treat rheumatoid arthritis (D2T RA) and severe, refractory Sjogren's disease (srSjD) with organ involvement.

Study Timeline

• Study Start: 2025-06-20
• Study First Submitted: 2025-06-24
• Study First Submitted QC: 2025-06-24
• Status Verified: 2025-07
• Study First Posted: 2025-07-02
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-15
• Primary Completion: 2028-09-15
• Study Completion: 2028-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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 For RA only
• Diagnosis of rheumatoid arthritis
• Treatment failure of standard of care therapies
• Active disease For SjD only
• Diagnosis of Sjogren's disease
• Active disease

Exclusion Criteria

• BMI at Screening of ≤18.5 or ≥35 kg/m2
• 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
• Any psychiatric condition or disability making compliance with treatment or informed consent impossible

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapcabtagene autoleucel-rheumatoid arthritis	Rapcabtagene autoleucel	Single infusion of Rapcabtagene autoleucel in participants with rheumatoid arthritis
Rapcabtagene autoleucel- Sjögren's Disease	Rapcabtagene autoleucel	Single infusion of Rapcabtagene autoleucel in participants with Sjögren's Disease

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	24 months	Safety parameters include vital signs, adverse events, laboratory parameters and ECG evaluation

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) parameter: Cmax	24 months	CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Maximum observed blood concentration Cmax).
PK parameter: Tmax	24 months	CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Time to reach maximum concentration Tmax).
PK parameter: T1/2	24 months	CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Terminal elimination half-life T1/2).
PK parameter: Clast	24 months	CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Last measurable concentration Clast).
PK parameter: AUC	24 months	CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Area under plasma concentration -time AUC).
PK parameter: Tlast	24 months	CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Time to reach last measurable concentration Tlast).

Trial Locations

Locations (1)

Novartis Investigative Site; 🇪🇸 Madrid, Spain