Status:
WITHDRAWN
A Study of IMPT-514 in Active Refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
Lyell Immunopharma, Inc.
Conditions:
Systemic Lupus Erythematosus
Lupus Nephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-514, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Willing and able to provide written informed consent
- Age 18 years of age or older
- Weight \> 45 kg at enrollment
- Adequate blood pressure control
- On stable background therapy for autoimmune disease (LN, SLE) with stable dose of autoimmune disease medications for at least 4 weeks prior to screening
- Diagnosis of SLE by 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria or 2012 Systemic Lupus Collaborating Clinics (SLICC) criteria, including positive ANA or positive anti-dsDNA
- Positive anti-nuclear antibody (ANA), anti-dsDNA (double stranded DNA) or anti-Smith antibody at screening
- SLE participants: SLEDAI-2K ≥ 6 points, with at least 4 points on clinical, non-laboratory items
- SLE participants: British Isles Lupus Assessment Group (BILAG) 2004 level B in 2 or more organ systems, or BILAG level A in 1 or more organ system
- Physician Global assessment ≥ 1 on 0 to 3 visual analogue scale (VAS)
- LN participants: Active, biopsy-proven, proliferative LN Class III or IV by 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria
- Other protocol-defined criteria apply.
- Exclusion criteria:
- Any clinically significant underlying illness, other than SLE and LN, which would pose a safety risk or concern, as determined by the Investigator
- Any other systemic autoimmune condition
- Rapidly progressive glomerulonephritis
- Active central nervous system (CNS) lupus
- History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation
- History of prior B cell directed cell therapy, including CAR T treatment, autologous or allogeneic, as well as prior bispecific or T cell engager therapy
- Drug-induced SLE
- Other protocol-defined criteria apply.
Exclusion
Key Trial Info
Start Date :
February 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06153095
Start Date
February 15 2024
End Date
January 9 2025
Last Update
February 10 2025
Active Locations (4)
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1
University of California, Los Angeles (UCLA) Medical Center
Los Angeles, California, United States, 90095
2
University of California San Francisco
San Francisco, California, United States, 94143
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
Westmead Hospital
Westmead, Australia, NSW 2145