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NCT06581198 · ClinicalTrials.gov registry record · Phase 2
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
A Phase 2 study of Lupus Nephritis and Lupus Erythematosus, Systemic, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 179
- Enrollment target
- 20
- Study locations
NCT06581198: Recruiting Phase 2 study of Lupus Nephritis and Lupus Erythematosus, Systemic, sponsored by Novartis Pharmaceuticals.
NCT06581198 is a Phase 2 study of Lupus Nephritis and Lupus Erythematosus, Systemic that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 179 participants, below the 304-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06581198, a Phase 2 study of Lupus Nephritis and Lupus Erythematosus, Systemic, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 179 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
Defined as: Meeting the criteria of the Definition Of Remission In Systemic Lupus Erythematosus (DORIS) or Achieving complete renal response (CRR)
Conditions Studied
Interventions
- BIOLOGICAL rapcabtagene autoleucel
Study Locations (20)
California
- Loma Linda University - San Bernardino
- UCSF - San Francisco
- UCSF - San Francisco
- Sutter Health Network - San Pablo
Illinois
- Ann and Robert H Lurie Childs Hosp - Chicago
- Northwestern University - Chicago
Massachusetts
- Tufts Medical Center - Boston
- Boston Medical Center - Boston
Texas
- Univ Of TX MD Anderson CC - Houston
- University of Texas MD Anderson Cancer Center - Houston
Utah
- LDS Hospital - Salt Lake City
- LDS Hospital - Salt Lake City
Other
- Novartis Investigative Site - Graz
- Novartis Investigative Site - Vienna
Alabama
- University Of Alabama - Birmingham
Iowa
- University Of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2024-09-04 |
| Est. Completion | 2032-02-06 |
| Phase | Phase 2 |
What NCT06581198 shows while recruiting
NCT06581198 is an interventional study that assigns participants to a tested intervention. The registered 179 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (41% lower).
The record links to 2 conditions, with Lupus Nephritis appearing as the primary indexed condition, and to 1 intervention - of which rapcabtagene autoleucel is the first listed.
NCT06581198 names 20 study sites across 12 states, led by California, Illinois, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06581198 about?
NCT06581198 is a clinical study titled "A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)". 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).
What is the current status of trial NCT06581198?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 179 participants. The study started on 2024-09-04. Estimated completion is 2032-02-06.
What conditions does trial NCT06581198 study?
This clinical trial studies the following conditions: Lupus Nephritis, Lupus Erythematosus, Systemic.
What interventions are being tested in trial NCT06581198?
The interventions under investigation include: rapcabtagene autoleucel (BIOLOGICAL).
Who is sponsoring clinical trial NCT06581198?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06581198 being conducted?
This trial has 20 study locations across Alabama, California, Illinois, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06581198's enrollment target sits among peer trials
179 10th of 30 higher than 21 of 30 other Lupus Nephritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Nephritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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