Trials / Terminated
TerminatedNCT06462144
IMPT-514 in Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory Myopathy
An Exploartory Trial of IMPT-514, An Autologous Anti-CD19/20 CAR T Therapy in Participants With Active, Refractory Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory Myopathy
- Status
- Terminated
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is an exploratory trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of IMPT-514, an autologous, anti-CD19/CD20 CAR T therapy, administered as an intravenous (IV) infusion, in participants with B cell driven autoimmune diseases, including active, refractory Systemic Lupus Erythematosus (SLE), ANCA Associated Vasculitis (AAV), and Idiopathic Inflammatory Myopathy (IIM).
Detailed description
This study will explore the safety of IMPT-514 and will include up to two dose levels, with up to 12 total expected dosed participants for each disease group of SLE, AAV, and IIM. 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 2 year from IMPT-415 administration.
Conditions
- Systemic Lupus Erythematosus (SLE)
- ANCA Associated Vasculitis (AAV)
- Idiopathic Inflammatory Myopathy (IIM)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IMPT-514 CART Cell Injection | CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. |
Timeline
- Start date
- 2024-06-13
- Primary completion
- 2025-10-21
- Completion
- 2025-10-21
- First posted
- 2024-06-17
- Last updated
- 2026-01-28
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06462144. Inclusion in this directory is not an endorsement.