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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06581198
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • rapcabtagene autoleucel — BIOLOGICAL
    single infusion of rapcabtagene autoleucel

Study Details

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).

Key Dates

Start date
Sep 4, 2024
Status verified
Jun 2026
Primary completion
Feb 14, 2028
Completion
Feb 6, 2032

Study Design

Enrollment
179 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: rapcabtagene autoleucel
    rapcabtagene autoleucel

Primary Outcome Measure

Evaluate the efficacy of rapcabtagene autoleucel [ Time Frame: Week 24, Week 52 ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
University Of AlabamaBirminghamAlabama35294
Laura Laupus
[email protected]
205-996-7438
Jose Enrique Rubio Mosquera (PRINCIPAL_INVESTIGATOR)
Loma Linda UniversitySan BernardinoCalifornia92408
Alejandra Beltran
[email protected]
909-651-1002
Sayna Norouzi (PRINCIPAL_INVESTIGATOR)
UCSFSan FranciscoCalifornia94115
Zilan Zheng
[email protected]
415-353-1301
Emily Von Scheven (PRINCIPAL_INVESTIGATOR)
UCSFSan FranciscoCalifornia94115
Emily Von Scheven (PRINCIPAL_INVESTIGATOR)
Sutter Health NetworkSan PabloCalifornia94806
Canary Jumawan
[email protected]
Neftali Nevarez (PRINCIPAL_INVESTIGATOR)
Ann and Robert H Lurie Childs HospChicagoIllinois60611
Sonali Chaudhury (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Kaitlin King
[email protected]
George Georges (PRINCIPAL_INVESTIGATOR)
University Of IowaIowa CityIowa52242
Darby Donovan
[email protected]
319-356-2197
Hanna Zembrzuska (PRINCIPAL_INVESTIGATOR)
University of KentuckyLexingtonKentucky40536-0284
Dorothy Ross
[email protected]
Paramarajan Piranavan (PRINCIPAL_INVESTIGATOR)
Boston Medical CenterBostonMassachusetts02118
Bharath Miriyam
[email protected]
617-638-9136
Hanni Menn-Josephy (PRINCIPAL_INVESTIGATOR)
Tufts Medical CenterBostonMassachusetts02111
Angela Chavez
[email protected]
617-636-6227
Andreas Klein (PRINCIPAL_INVESTIGATOR)
WA Uni School Of MedSt LouisMissouri63110
Monica Sewell
[email protected]
314-454-8293
Tingting Li (PRINCIPAL_INVESTIGATOR)
Duke Clinical Research InstituteDurhamNorth Carolina27710
Eileen Phifer
[email protected]
Kris Mahadeo (PRINCIPAL_INVESTIGATOR)
Oregon Health Sciences UniversityPortlandOregon97239
Issabell Melz
[email protected]
503-494-9021
Atul Deodhar (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030
Taylor Madison
[email protected]
Sarah Kazzaz (PRINCIPAL_INVESTIGATOR)
Univ Of TX MD Anderson CCHoustonTexas77030
Cattleya Musni
[email protected]
Samer Srour (PRINCIPAL_INVESTIGATOR)
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Maria Suarez-Almazor
[email protected]
713-563-0020
Samer Srour (PRINCIPAL_INVESTIGATOR)
LDS HospitalSalt Lake CityUtah84143
Tara Sou
[email protected]
801-408-4712
Catherine Jennifer Bakewell (PRINCIPAL_INVESTIGATOR)
LDS HospitalSalt Lake CityUtah84143
Tara Sou
[email protected]
801-408-1100
Catherine Jennifer Bakewell (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
University Of Alabama· Birmingham, ALLoma Linda University· San Bernardino, CAUCSF· San Francisco, CASutter Health Network· San Pablo, CAAnn and Robert H Lurie Childs Hosp· Chicago, ILNorthwestern University· Chicago, IL

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