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

Cartesian Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Refractory Multiple Myeloma; Relapsed Multiple Myeloma

Treatments: Drug: Descartes-15

Study type: Interventional

Funder types: Industry

Identifiers

NCT06304636

DC15-MM-01

Details and patient eligibility

About

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

Enrollment: 41 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

Part 1 Descartes-15 with lymphodepletion

Experimental group

Description:

Intra-patient dose escalation arm with three dose levels over the course of six infusions of cell product. Patients will receive lymphodepletion prior to initiating cell therapy.

Treatment:

Drug: Descartes-15

Part 2 Arm 1 Descartes-15 with lymphodepletion

Experimental group

Description:

Descartes-15 infusions at the maximum tolerated dose level from Part 1. Patients will receive lymphodepletion prior to initiating cell therapy.

Treatment:

Drug: Descartes-15

Part 2 Arm 2 Descartes-15 without lymphodepletion

Experimental group

Description:

Descartes-15 infusions at the maximum tolerated dose level from Part 1. Patients will not receive lymphodepletion prior to initiating cell therapy.

Treatment:

Drug: Descartes-15