NCT07048197

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
30mo left

Started Jun 2025

Typical duration for phase_1

Geographic Reach
4 countries

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jun 2025Nov 2028

Study Start

First participant enrolled

June 20, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

3.4 years

First QC Date

June 24, 2025

Last Update Submit

March 27, 2026

Conditions

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

Keywords

CAR-T,YTB323,rapcabtagene autoleucel,D2T RA,srSjD

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

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

    24 months

Secondary Outcomes (6)

  • Pharmacokinetic (PK) parameter: Cmax

    24 months

  • PK parameter: Tmax

    24 months

  • PK parameter: T1/2

    24 months

  • PK parameter: Clast

    24 months

  • PK parameter: Tlast

    24 months

  • +1 more secondary outcomes

Study Arms (2)

Rapcabtagene autoleucel-rheumatoid arthritis

EXPERIMENTAL

Single infusion of Rapcabtagene autoleucel in participants with rheumatoid arthritis

Biological: Rapcabtagene autoleucel

Rapcabtagene autoleucel- Sjögren's Disease

EXPERIMENTAL

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

Biological: Rapcabtagene autoleucel

Interventions

Rapcabtagene autoleucelBIOLOGICAL

Single infusion of Rapcabtagene autoleucel

Rapcabtagene autoleucel- Sjögren's DiseaseRapcabtagene autoleucel-rheumatoid arthritis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Novartis Investigative Site

Bordeaux, 33076, France

RECRUITING

Novartis Investigative Site

Brest, 29200, France

RECRUITING

Novartis Investigative Site

Le Kremlin-Bicêtre, 94275, France

RECRUITING

Novartis Investigative Site

Lille, 59037, France

RECRUITING

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

RECRUITING

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Novartis Investigative Site

Berlin, 13353, Germany

RECRUITING

Novartis Investigative Site

Ulm, 89081, Germany

RECRUITING

Novartis Investigative Site

Singapore, 119074, Singapore

RECRUITING

Novartis Investigative Site

Barcelona, 08035, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28034, Spain

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 2, 2025

Study Start

June 20, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

ES(2)SG(1)DE(4)FR(4)