Trials / Active Not Recruiting
Active Not RecruitingNCT06152172
CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101
CARTIMMUNE: A Single-Center Study of Patients With Autoimmune Diseases Receiving an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (KYV 101)
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- David Porter · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety, tolerability, and clinical activity of KYV 101 (a fully-human anti-CD19 CAR T-cell therapy) in adult subjects with B cell-driven autoimmune diseases. The trial anticipates enrolling participants to reach a maximum of 24 participants who will receive 1 dose of KYV-101 and will be followed for 2 years.
Detailed description
The purpose of this study is to assess the safety, tolerability, and clinical activity of KYV 101 (a fully-human anti-CD19 CAR T-cell therapy) in 24 adult subjects with B cell-driven autoimmune diseases. The diseases under study include: idiopathic necrotizing myopathy (INM) consisting of dermatomyositis (DM), necrotizing myopathy, anti-HMGCoA-associated myopathy, and polymyositis (PM), diffuse cutaneous systemic sclerosis (dcSSc), systemic lupus erythematosus (SLE) with nephritis, and ANCA-associated vasculitis (AAV). Six participants in each autoimmune disease group for a total of 24 participants will receive a single dose of 1.0×10\[8\] CAR+ T cells. Participants will be followed under this protocol for 2 years. Lymphodepleting chemotherapy of cyclophosphamide (CYC) 300 mg/m2 and fludarabine (FLU) 30 mg/m2 intravenously (IV) daily for 3 days will be administered 5 to 7 days prior to administration of KYV-101.
Conditions
- Idiopathic Inflammatory Myopathies
- Diffuse Cutaneous Systemic Sclerosis
- SLE Nephritis
- ANCA Associated Vasculitis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KYV-101 | The KYV-101 will be administered IV as a single infusion dosed at 1×108 CAR+ T cells. |
| DRUG | Cyclophosphamide | Lymphodepleting chemotherapy of cyclophosphamide (CYC) 300 mg/m2 |
| DRUG | Fludarabine | Lymphodepleting chemotherapy of Fludarabine (FLU) 30 mg/m2 intravenously (IV) |
Timeline
- Start date
- 2024-08-05
- Primary completion
- 2027-02-01
- Completion
- 2027-02-01
- First posted
- 2023-11-30
- Last updated
- 2026-02-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06152172. Inclusion in this directory is not an endorsement.