ACTIVE_NOT_RECRUITING

Descartes-08 for Patients With Systemic Lupus Erythematosus

Conditions

Systemic Lupus Erythematosus (SLE)Descartes-08 CART CAR-T Autoimmune Auto-antibody Auto antibody chimeric antigen receptor T cells Lupus SLE Lupus Erythematosus Systemic Lupus Erythematosus LE

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Descartes-08 for Patients With Systemic Lupus Erythematosus

Quick Facts

Study Start:2024-02-12

Study Completion:2026-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06038474

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Locations (Sites)

Profound Research LLC

Oceanside, California, 92056

United States

Collaborators and Investigators

Sponsor: Cartesian Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-12

Study Completion Date2026-11-01

Study Record Updates

Study Start Date2024-02-12

Study Completion Date2026-11-01

Terms related to this study

Keywords Provided by Researchers

Descartes-08
CART
CAR-T
Autoimmune
Auto-antibody
Auto antibody
chimeric antigen receptor
T cells
Lupus
SLE
Lupus Erythematosus
Systemic Lupus Erythematosus
LE

Additional Relevant MeSH Terms

Systemic Lupus Erythematosus (SLE)