Descartes-08 for Patients With Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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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).

Official Title
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Descartes-08 for Patients With Systemic Lupus Erythematosus

Conditions
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Systemic Lupus Erythematosus (SLE)

Intervention / Treatment
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* Drug: Descartes-08


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Descartes-08<br>Drug: Descartes-08 Autologous T-cells expressing a chimeric antigen receptor directed to BCMA | Drug: Descartes-08<br>* Autologous T-cells expressing a chimeric antigen receptor directed to BCMA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety and tolerability of Descartes-08 in patients with systemic lupus erythematosus (SLE) | 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. | Day -59 to Day 50 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) | Assessment of Systemic Lupus Erythematosus Disease Activity Index 2000 from baseline administration at various timepoints up to month 12 follow up visit. | Day -59 to Month 12 | 
| Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Responder Index (SRI) | Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at various timepoints up to month 12 follow up visit. | Day -59 to Month 12 | 
| Quantify the clinical activity of Descartes-08 in patients with SLE using British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) | Assessment of British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) at various timepoints up to month 12 follow up visit. | Day -59 to Month 12 | 
| Quantify the clinical activity of Descartes-08 in patients with SLE using Physician Global Assessment (PGA) | Assessment of Physician Global Assessment (PGA) from baseline administration at various timepoints up to month 12 follow up visit. | Day -59 to Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus, SLE, Lupus Erythematosus, Systemic Lupus Erythematosus, LE, Descartes-08, CART, CAR-T, Autoimmune, Auto-antibody, Auto antibody, chimeric antigen receptor, T cells