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New treatment option for Myasthaenia Gravis
Official title Investigating an mRNA CAR T-cell Therapy, Known as Descartes-08, as a Potential Approach to Treat Myasthenia Gravis
ClinicalTrials.gov ID: NCT06799247
What this study is testing
What is Decartes-08?
Decartes-08 is an investigational medicine, being studied as a potential treatment for myasthaenia gravis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The AURORA Study is evaluating the safety, tolerability, and efficacy of an investigational mRNA CAR T-cell therapy known as Descartes-08 in adults with acetylcholine receptor autoantibody -positive generalized myasthenia gravis. Part 1 of the study will last around 6 months.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient must be at least 18 years of age.
- Patient must have generalized myasthenia gravis (gMG), Myasthenia Gravis Foundation of America (MGFA) clinical classification grades 2-4 at the time...
- MG-Activities of Daily Living (MG ADL) total score ≥ 6.
- Concomitant immunosuppressive drugs must be deemed necessary by the investigator. The dose must be stable for a minimum of 8 weeks prior to Baseline...
- If a patient is using corticosteroids, the daily dose should not exceed 40 mg/day of prednisone equivalent. The dose must have been stable for a...
You likely can't join if
- 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.
- Diagnosis of gMG within 12 months of screening.
- No history of systemic treatment for gMG other than acetylcholine esterase inhibitors.
- Diagnosis of a neuromuscular disease other than gMG.
- Patient is pregnant or lactating.
- Treatment with intravenous immunoglobulin (IVIG) or plasma exchange within 4 weeks prior to the Baseline visit.
See the full eligibility criteria
- Patient must be at least 18 years of age.
- Patient must have generalized myasthenia gravis (gMG), Myasthenia Gravis Foundation of America (MGFA) clinical classification grades 2-4 at the time of Sscreening.
- MG-Activities of Daily Living (MG ADL) total score ≥ 6.
- Concomitant immunosuppressive drugs must be deemed necessary by the investigator. The dose must be stable for a minimum of 8 weeks prior to Baseline visit.
- If a patient is using corticosteroids, the daily dose should not exceed 40 mg/day of prednisone equivalent. The dose must have been stable for a minimum of 8 weeks prior to Baseline visit.
- Acetylcholine receptor autoantibody (anti-nAChR) titer or anti-AChR cluster antibody must be above the reference laboratory upper normal limit (UNL) and documented within the past 10 years of screening.
- Patient must be willing to return for all study visits.
- Patient must be able to give written informed consent.
- Women of childbearing potential must agree to use highly effective birth control from Screening until 14 days post last dose of Descartes-08,
- 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.
- Diagnosis of gMG within 12 months of screening.
- No history of systemic treatment for gMG other than acetylcholine esterase inhibitors.
- Diagnosis of a neuromuscular disease other than gMG.
- Patient is pregnant or lactating.
- Treatment with intravenous immunoglobulin (IVIG) or plasma exchange within 4 weeks prior to the Baseline visit.
- Treatment with rituximab or ocrelizumab within 12 months prior to Baseline visit; treatment with calcineurin inhibitors (e.g. tacrolimus, cyclosporine, cyclophosphamide), Neonatal Fc receptor antagonists, and/or other...
- The patient has started treatment with a complement 5a (C5a) inhibitor, such as eculizumab, within 8 weeks of Baseline visit. (NOTE: patients who have been receiving a C5a inhibitor for more than 8 weeks and meet other...
- Prior treatment with B-cell maturation antigen (BCMA)-directed therapy (e.g. monoclonal antibody, T-cell engager, or chimeric antigen receptor T-cell [CAR-T]).
- Abnormal prothrombin (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) increased \> 1.5-fold above the normal range at Screening or patient is on anticoagulation therapy (except in cases of...
- Absolute neutrophil count (ANC) \< 1000 cells/microliter.
- Hemoglobin \< 8.0 g/dL.
- Platelets \< 50,000/mm3.
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 3x above normal.
- Creatine clearance less than 30 mL/min.
- History of primary immunodeficiency, organ, or allogeneic bone marrow transplant.
- Patients must be seronegative for hepatitis B surface antigen.
- Patients must be seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patients must be tested for the presence of viremia by reverse transcriptase polymerase chain reaction (RT-PCR) and...
- History of positive human immunodeficiency virus (HIV) or positive HIV at screening.
- Active tuberculosis or positive QuantiFERON test at screening.
- Any other clinical or laboratory abnormality that, in the opinion of the investigator, may jeopardize the subject's ability to participate in the study or could affect study outcome.
- Any active significant cardiac or pulmonary disease that, in the opinion of the Principal Investigator, is significant and/or uncontrolled. Note: Patients with asthma and chronic obstructive pulmonary disease (COPD)...
- History of malignancy that required treatment in the past 3 years, except for squamous cell carcinoma, basal cell carcinoma of the skin, or breast or early-stage colon cancer that is surgically removed and did not...
- Treatment with any investigational agent 4 weeks prior to screening or 5 half-lives of the investigational drug (whichever is longer).
- Receipt of a live vaccination within 4 weeks prior to Baseline visit or intent to receive live vaccination during the study (Note: messenger RNA [mRNA]-based vaccines such as those against severe acute respiratory...
- History of significant recurrent infections or any active infection that in the opinion of the Investigator may interfere with the patient's participation in the opinion of the investigator.
- Any known psychiatric illness that in the opinion of the Investigator, may interfere with the patient's participation in the study in the opinion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Carlsbad, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Maitland, Florida, United States
- Tampa, Florida, United States
- O'Fallon, Illinois, United States
- Fairway, Kansas, United States
- Lexington, Kentucky, United States
- Boston, Massachusetts, United States
- Amherst, New York, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Charlotte, North Carolina, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Carlsbad, California, United States; Los Angeles, California, United States; Orange, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.