Last Update: Jul 02, 2025
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CYTB323M12101B
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

Difficult-to-treat Rheumatoid Arthritis (RA) and Severe, Refractory Sjögren's Disease (SjD)
Phase1, Phase2
Recruiting
18
Jun 20, 2025
Jul 14, 2028
All
18 Years - 65 Years (Adult, Older Adult)

Interventions

Biological

Rapcabtagene autoleucel

Single infusion of Rapcabtagene autoleucel

Eligibility Criteria

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.

Novartis Investigative Site

Recruiting

Singapore,119074,Singapore

Worldwide Contacts

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Novartis Pharmaceuticals