A Study of IMPT-514 in Active Refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE)
NCT ID: NCT06153095
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2024-02-15
2025-01-09
Brief Summary
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IMPT-514 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Individual participants will remain in the active post-treatment period for approximately 1 year.
Participants will continue in long-term follow-up for 15 years from treatment.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1 Lupus Nephritis
Administration of IMPT-514
IMPT-514
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide
Phase 2 Lupus Nephritis
Administration of IMPT-514
IMPT-514
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide
Phase 2 SLE without Lupus Nephritis
Administration of IMPT-514
IMPT-514
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide
Interventions
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IMPT-514
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide
IMPT-514
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide
IMPT-514
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide
Eligibility Criteria
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Inclusion Criteria
2. Age 18 years of age or older
3. Weight \> 45 kg at enrollment
4. Adequate blood pressure control
5. On stable background therapy for autoimmune disease (LN, SLE) with stable dose of autoimmune disease medications for at least 4 weeks prior to screening
6. 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
7. Positive anti-nuclear antibody (ANA), anti-dsDNA (double stranded DNA) or anti-Smith antibody at screening
8. SLE participants: SLEDAI-2K ≥ 6 points, with at least 4 points on clinical, non-laboratory items
9. 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
10. Physician Global assessment ≥ 1 on 0 to 3 visual analogue scale (VAS)
11. 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
2. Any other systemic autoimmune condition
3. Rapidly progressive glomerulonephritis
4. Active central nervous system (CNS) lupus
5. History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation
6. 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
7. Drug-induced SLE
Other protocol-defined criteria apply.
18 Years
ALL
No
Sponsors
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Lyell Immunopharma, Inc.
INDUSTRY
Responsible Party
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Locations
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University of California, Los Angeles (UCLA) Medical Center
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
University of Iowa
Iowa City, Iowa, United States
Westmead Hospital
Westmead, , Australia
Countries
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Other Identifiers
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MPCT-021N
Identifier Type: -
Identifier Source: org_study_id
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