Trials / Active Not Recruiting
Active Not RecruitingNCT06255028
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
The CALiPSO-1 Study: A Study of CNTY-101, a CD19-targeted CAR iNK Cell Product, in Participants With Refractory B Cell-mediated Autoimmune Diseases
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Century Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
Summary
CALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic lupus erythematosus (SLE) with or without lupus nephritis (LN), idiopathic inflammatory myopathies (IIM), and diffuse cutaneous systemic sclerosis (DcSSc).
Conditions
- Systemic Lupus Erythematosus
- Lupus Nephritis
- Idiopathic Inflammatory Myopathies
- Diffuse Cutaneous Systemic Sclerosis
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CNTY-101 | CNTY-101 cells for intravenous (IV) infusion |
| BIOLOGICAL | IL-2 | IL-2 subcutaneous (SC) injection |
| DRUG | Lymphodepleting Chemotherapy | LDC as prespecified in the protocol. |
Timeline
- Start date
- 2025-02-06
- Primary completion
- 2028-08-01
- Completion
- 2028-08-01
- First posted
- 2024-02-12
- Last updated
- 2026-01-08
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06255028. Inclusion in this directory is not an endorsement.