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Recruiting NCT07048197

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

Phase I / Phase II Interventional Rheumatoid Arthritis (RA) and Sjögren's Disease (SjD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rapcabtagene autoleucel.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis (RA) and Sjögren's Disease (SjD). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Germany, Singapore, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological Rapcabtagene autoleucel
    Single infusion of Rapcabtagene autoleucel

Primary outcome measures

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Time frame: 24 months]
Secondary outcome measures (6)
  • Pharmacokinetic (PK) parameter: Cmax [Time frame: 24 months]
  • PK parameter: Tmax [Time frame: 24 months]
  • PK parameter: T1/2 [Time frame: 24 months]
  • PK parameter: Clast [Time frame: 24 months]
  • PK parameter: Tlast [Time frame: 24 months]
  • PK parameter: AUC [Time frame: 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 5 centers
  • Novartis Investigative Site — Freiburg im Breisgau
  • Novartis Investigative Site — Göttingen
  • Novartis Investigative Site — Cologne
  • Novartis Investigative Site — Berlin
  • Novartis Investigative Site — Ulm
France · 4 centers
  • Novartis Investigative Site — Bordeaux
  • Novartis Investigative Site — Brest
  • Novartis Investigative Site — Le Kremlin-Bicêtre
  • Novartis Investigative Site — Lille
Spain · 2 centers
  • Novartis Investigative Site — Barcelona
  • Novartis Investigative Site — Madrid
Singapore · 1 center
  • Novartis Investigative Site — Singapore

Identifiers

NCT: NCT07048197 · CYTB323M12101B · 2024-514596-18-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗