NCT06153095WithdrawnPhase 1/2
A Study of IMPT-514 in Active Refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE)
A Phase 1/2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of IMPT-514 in Participants With Active, Refractory Lupus Nephritis and Systemic Lupus Erythematosus
Source: ClinicalTrials.gov · Last updated 10 Feb 2025
Brief summary (registry, in English)
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 participants with active, refractory lupus nephritis and systemic lupus erythematosus. 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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 22 Nov 2023
- Start date
- 15 Feb 2024
- Primary completion date
- 9 Jan 2025
- Lead sponsor
- Lyell Immunopharma, Inc.
- Diseases
- Lupus (SLE)
- NCT number
- NCT06153095
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
- History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation
Other
- Rapidly progressive glomerulonephritis
- Active central nervous system (CNS) lupus
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Westmead Hospital | Westmead | Australia | Unknown status |
| University of Iowa | Iowa City | United States | Unknown status |
| University of California, Los Angeles (UCLA) - Medical Center | Los Angeles | United States | Unknown status |
| University of California San Francisco | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.