Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma DC15-MM-01

What's the purpose of this trial?

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

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Additional Trial Information

Phase 1

Enrollment: 41 patients (estimated)

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Trial Locations

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Maryland

American Oncology Partners of Maryland (Bethesda) The Center for Cancer & Blood Disorders - Bethesda

Bethesda, MD

Open and Accepting
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