Systemic Lupus Erythematosus (SLE)
Conditions
Keywords
Descartes-08, CART, CAR-T, Autoimmune, Auto-antibody, Auto antibody, chimeric antigen receptor, T cells, Lupus, SLE, Lupus Erythematosus, Systemic Lupus Erythematosus, LE
Brief summary
This is a Phase II study to evaluate the safety, tolerability and manufacturing feasibility of Descartes-08 CAR T-cells in patients with Systematic Lupus erythematosus (SLE).
Interventions
DRUGDescartes-08
Autologous T-cells expressing a chimeric antigen receptor directed to BCMA
Sponsors
Cartesian Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be at least 18 years of age. * Patient must have systemic lupus erythematosus (SLE) at the time of screening. * Active symptoms despite recent or ongoing immunosuppressive therapy with glucocorticoids and at least 2 other immunosuppressive medications being tried for at least 12 weeks within 24 months of screening. * At least one of: anti-dsDNA, anti-histone, anti-chromatin, and/or anti-Sm antibodies detectable at screening as assessed by a CLIA-certified laboratory.
Exclusion criteria
* Active severe lupus nephritis, active severe CNS lupus, and/or neurological symptoms of SLE including headache, seizure, psychosis, and organic brain syndrome (a patient with an incidental headache, deemed unrelated to SLE, may re-screen by telephone upon resolution of the headache); * Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient. * Patient is pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess safety and tolerability of Descartes-08 in patients with systemic lupus erythematosus (SLE) | Day -59 to Day 50 | Results will be descriptive. Safety and tolerability endpoints will include descriptive statistics of AEs and SAEs. Patients must be followed until all AEs have resolved to Grade 2 or less except for lymphopenia and alopecia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) | Day -59 to Month 12 | Assessment of Systemic Lupus Erythematosus Disease Activity Index 2000 from baseline administration at various timepoints up to month 12 follow up visit. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity. |
| Assess the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Responder Index (SRI) | Day -59 to Month 12 | Assessment of whether participants meet the Systemic Lupus Erythematosus Responder Index (SRI) criteria (Yes/No) at various timepoints up to month 12 follow up visit. |
| Assess the clinical activity of Descartes-08 in patients with SLE using British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) | Day -59 to Month 12 | Assessment of whether participants meet the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) criteria (Yes/No) at various timepoints up to month 12 follow up visit. |
| Quantify the clinical activity of Descartes-08 in patients with SLE using Physician Global Assessment (PGA) | Day -59 to Month 12 | Assessment of Physician Global Assessment (PGA) from baseline administration at various timepoints up to month 12 follow up visit. A total score can fall between 0.0 and 3.0, with a higher score representing a more significant degree of disease activity. |
Countries
United States
Outcome results
None listed