Systemic Lupus Erythematosus (SLE)Phase 2SLE-001NCT06038474
Descartes-08 for Patients With Systemic Lupus Erythematosus
A Phase 2 study testing Descartes-08 in people with Systemic Lupus Erythematosus (SLE), run by Cartesian Therapeutics at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- Descartes-08
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to 1 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- Descartes-08
- Keywords
- Descartes-08, CART, CAR-T, Autoimmune, Auto-antibody, Auto antibody, chimeric antigen receptor, T cells, Lupus, SLE, Lupus Erythematosus, Systemic Lupus Erythematosus, LE
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descartes-08Drug
Autologous T-cells expressing a chimeric antigen receptor directed to BCMA
| Study group | Role | What they receive |
|---|---|---|
| Descartes-08 | Other | Drug: Descartes-08
Autologous T-cells expressing a chimeric antigen receptor directed to BCMA Receives: Drug: Descartes-08 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day -59 to Day 50
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day -59 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start12 Feb 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cartesian Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038474
- Sponsor's protocol ID
- DC08-SLE-001
- Acronym
- SLE-001
- Status last verified
- Mar 2026
- First submitted
- 8 Sep 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descartes-08 for Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06038474
- Acronym / sponsor ID
- SLE-001 / DC08-SLE-001
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Keywords
- Descartes-08, CART, CAR-T, Autoimmune, Auto-antibody, Auto antibody, chimeric antigen receptor, T cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cartesian TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Descartes-08 | Other | Drug: Descartes-08Drug: Descartes-08 Autologous T-cells expressing a chimeric antigen receptor directed to BCMA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Descartes-08Autologous T-cells expressing a chimeric antigen receptor directed to BCMA | Drug | Descartes-08 |
Primary outcome
Assess safety and tolerability of Descartes-08 in patients with systemic lupus erythematosus (SLE)
Time frame: 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.
4 secondary outcomes
Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
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)
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)
Time frame: Day -59 to Month 12
Quantify the clinical activity of Descartes-08 in patients with SLE using Physician Global Assessment (PGA)
Time frame: Day -59 to Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Systemic Lupus Erythematosus (SLE)
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Descartes-08 in people with Systemic Lupus Erythematosus (SLE), run by Cartesian Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess safety and tolerability of Descartes-08 in patients with systemic lupus erythematosus (SLE) (time frame: Day -59 to Day 50). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.