Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma

NCT ID: NCT06304636

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-19
• Study Completion Date: 2025-11-13

Brief Summary

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

Conditions

Refractory Multiple Myeloma; Relapsed Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1 Descartes-15 with lymphodepletion

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.

Group Type: EXPERIMENTAL

Descartes-15

Intervention Type: DRUG

Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA

Part 2 Arm 1 Descartes-15 with lymphodepletion

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

Group Type: EXPERIMENTAL

Descartes-15

Intervention Type: DRUG

Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA

Part 2 Arm 2 Descartes-15 without lymphodepletion

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

Group Type: EXPERIMENTAL

Descartes-15

Intervention Type: DRUG

Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA

Interventions

Descartes-15

Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cartesian Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Center for Cancer and Blood Disorders (AON)

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

DC15-MM-01

Identifier Type: -

Identifier Source: org_study_id