A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)

Novartis

Status and phase

Enrolling

Phase 2

Conditions

Lupus Erythematosus, Systemic

Lupus Nephritis

Treatments

Biological: rapcabtagene autoleucel

Study type

Interventional

Funder types

Industry

Identifiers

NCT06581198

2023-510150-17-00 (Registry Identifier)

CYTB323J12201

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN).

Enrollment

179 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Men and women with SLE, aged >= 18 years and =< 75 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE at screening.
Participant must be positive for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) at a titer of >= 1:80 (on HEp-2 cells or an equivalent positive test), or anti-dsDNA (above the ULN); or anti-Sm (above the ULN) as determined by a central laboratory.
Active lupus nephritis without signs of significant chronicity or active systemic lupus erythematosus
SLEDAI-2K Criteria at screening: SLEDAI-2K score >= 6 points (Gladman et al 2002, Touma et al 2011), excluding points attributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome".
Inadequate response at screening to at least two therapies

Key Exclusion Criteria:

Any acute, severe lupus related-flare at screening that needs immediate treatment other than pulse GCs and/or makes the immunosuppressive washout impossible and, thus, makes the participant ineligible for CD19 CAR-T therapy
Inadequate organ function during screening and prior to randomization
History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants prior to randomization
Human immunodeficiency virus (HIV) positivity at screening.
Acute or chronic infection with hepatitis B (HBV) or hepatitis C (HCV) at screening.
Grade 2 or higher thromboembolic event in the past 4 weeks prior to screening.

Other protocol-defined inclusion/exclusion criteria may apply.