Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma
Stopped early · Phase 1
Conditions studied: Refractory Multiple Myeloma, Relapsed Multiple Myeloma
In brief
This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15
Key facts
- Study ID
- NCT06304636
- Run by
- Cartesian Therapeutics
- People needed
- 4
- Starts
- 2024-06-19
- Expected to finish
- 2025-11-13
- Last updated by the study team
- 2025-11-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must be 18 years of age or older at the time of enrollment.
- Patients must be diagnosed with active and measurable relapsed/refractory multiple myeloma.
- Patients must have failed at least 3 prior lines of therapy which must have included an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug or biologic. Failure of treatment and measurable myeloma disease are defined as per 2016 IMWG criteria.
- Patients must have clinical performance status of ECOG 0-2.
- Patients must have adequate vital organ function as defined by:
- Hemoglobin ≥8 g/dL
- Absolute neutrophil count > 1000/ mm3
- Platelets > 50,000/mm3
- ALT/AST levels lower than 3-fold of normal
- Creatinine clearance ≥45 mL/min/1.73 m2
- Normal cardiac and pulmonary function
- No thromboembolic events in the past 3 months
- No heparin allergy or active infection
You may not qualify if…
- Patients who have any active and uncontrolled infection.
- Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above 40 mg/day prednisone equivalent).
- Patients who have active central nervous system disease.
Where it is running
- Center for Cancer and Blood Disorders (AON) — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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