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

Novartis

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Rheumatoid Arthritis (RA) and Sjögren's Disease (SjD)

Treatments: Biological: Rapcabtagene autoleucel

Study type: Interventional

Funder types: Industry

Identifiers

NCT07048197

2024-514596-18-00 (Other Identifier)

CYTB323M12101B

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent must be obtained prior to participation in the study
• Men and women aged ≥ 18 years and ≤ 75 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 ≤17 or ≥ 40 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Rapcabtagene autoleucel-rheumatoid arthritis

Experimental group

Description:

Single infusion of Rapcabtagene autoleucel in participants with rheumatoid arthritis

Treatment:

Biological: Rapcabtagene autoleucel

Rapcabtagene autoleucel- Sjögren's Disease

Experimental group

Description:

Single infusion of Rapcabtagene autoleucel in participants with Sjögren's Disease

Treatment:

Biological: Rapcabtagene autoleucel