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

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

Study Overview

• Status: Terminated
• Conditions: Refractory Multiple Myeloma; Relapsed Multiple Myeloma
• Intervention / Treatment: Drug: Descartes-15

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Center for Cancer and Blood Disorders (AON)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Descartes-15; Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA
Experimental: 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.	Drug: Descartes-15; Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA
Experimental: 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.	Drug: Descartes-15; Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM)	Results will be descriptive. Safety and tolerability endpoints are adverse events and serious adverse events as proportion of all participants at a given dose level and in the overall study population.	Day -60 to Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the anti-myeloma activity of Descartes-15, as measured by IMWG response criteria and progression-free survival	Efficacy will be assessed by descriptive statistics of treatment response per IMWG criteria. Efficacy endpoints will be reported as proportion of participants achieving Stable Disease (SD), Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) and stringent Complete Response (sCR) as the best response at a given dose level and in the overall study population.	Day 1 to Month 12

Collaborators and Investigators

• Sponsor: Cartesian Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2024
• Primary Completion (Actual): April 14, 2025
• Study Completion (Actual): November 13, 2025

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Myeloma; Relapsed/Refractory; T cells; CART; Relapsed Myeloma; Refractory Myeloma; Car-T; Descartes-15; Descartes; cell gene
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: DC15-MM-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No