Descartes-08 for Patients With Systemic Lupus Erythematosus

Phase 2Active Not RecruitingNCT06038474

Cartesian Therapeutics6 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Lupus Erythematosus (SLE)

Interventions

Descartes-08DRUG

Autologous T-cells expressing a chimeric antigen receptor directed to BCMA

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Profound Research LLC

Oceanside, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Day -59 to Day 50

Secondary Outcomes

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. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.

Time frame: Day -59 to Month 12

Assess the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Responder Index (SRI)

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.

Time frame: Day -59 to Month 12

Assess the clinical activity of Descartes-08 in patients with SLE using British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA)

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.

Time frame: 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. A total score can fall between 0.0 and 3.0, with a higher score representing a more significant degree of disease activity.

Data from ClinicalTrials.gov

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