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

Purpose

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).

Conditions

  • Lupus Erythematosus, Systemic
  • Lupus Nephritis

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
rapcabtagene autoleucel 		rapcabtagene autoleucel
  • Biological: rapcabtagene autoleucel
    single infusion of rapcabtagene autoleucel

Recruiting Locations

University Of Alabama
Birmingham 4049979, Alabama 4829764 35294
Contact:
Laura Laupus
205-996-7438
llaupus@uabmc.edu

Loma Linda University
San Bernardino 5391710, California 5332921 92408
Contact:
Alejandra Beltran
alejandrabeltran@llu.edu

UCSF
San Francisco 5391959, California 5332921 94115
Contact:
Zilan Zheng
415-353-1301
Zilan.Zheng@ucsf.edu

UCSF
San Francisco 5391959, California 5332921 94115
Contact:
Zilan Zheng
415-502-6627
zilan.zheng@ucsf.edu

Sutter Health Network
San Pablo 5392508, California 5332921 94806
Contact:
Canary Jumawan
canary.jumawan@sutterhealth.org

Ann and Robert H Lurie Childs Hosp
Chicago 4887398, Illinois 4896861 60611
Contact:
Eric Brown
errbrown@luriechildrens.org

Northwestern University
Chicago 4887398, Illinois 4896861 60611
Contact:
Neil Pillai
neil.pillai@northwestern.edu

University Of Iowa
Iowa City 4862034, Iowa 4862182 52242
Contact:
Darby Donovan
319-356-2197
darby-donovan@uiowa.edu

University of Kentucky
Lexington 4297983, Kentucky 6254925 40536-0284
Contact:
Dorothy Ross
dross3@email.uky.edu

Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111
Contact:
Angela Chavez
617-636-6227
angela.chavez@tuftsmedicine.org

Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118
Contact:
Bharath Miriyam
617-638-9136
Bharath.Miriyam@bmc.org

WA Uni School Of Med
St Louis 4407066, Missouri 4398678 63110
Contact:
Michelle Bloom
314-454-8293
mbloom@wustl.edu

Oregon Health Sciences University
Portland 5746545, Oregon 5744337 97239
Contact:
Kim Phung Karimzadeh
503-494-9021
nguykimp@ohsu.edu

Univ Of TX MD Anderson CC
Houston 4699066, Texas 4736286 77030
Contact:
Cattleya Musni
CCMusni@mdanderson.org

University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
Maria Suarez-Almazor
713-563-0020
msalmazor@mdanderson.org

LDS Hospital
Salt Lake City 5780993, Utah 5549030 84143
Contact:
Tara Sou
801-408-4712
tina.hockett@imail.org

LDS Hospital
Salt Lake City 5780993, Utah 5549030 84143
Contact:
Tara Sou
801-581-7715
tara.sou@imail.org

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com