Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma

NCT06304636 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: DC15-MM-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Keywords

Relapsed/Refractory; Relapsed Myeloma; Refractory Myeloma; Multiple Myeloma; Car-T; CART; Descartes-15; Descartes; Myeloma; T cells; cell gene

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To assess the anti-myeloma activity of Descartes-15, as measured by IMWG response criteria and progression-free survival

  Day 1 to Month 12

Study Arms (3)

Part 1 Descartes-15 with lymphodepletion

EXPERIMENTAL

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

Part 2 Arm 1 Descartes-15 with lymphodepletion

EXPERIMENTAL

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

Drug: Descartes-15

Part 2 Arm 2 Descartes-15 without lymphodepletion

EXPERIMENTAL

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

Interventions

Descartes-15 DRUG

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

Part 1 Descartes-15 with lymphodepletion; Part 2 Arm 1 Descartes-15 with lymphodepletion; Part 2 Arm 2 Descartes-15 without lymphodepletion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Cartesian Therapeutics: lead

Study Sites (1)

Center for Cancer and Blood Disorders (AON)

Bethesda, Maryland, 20817, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Recurrence; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study consists of two parts. Part 1 is a single-arm dose escalation study. Part 2 is a dose-expansion study with 2 arms.

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 12, 2024
• Study Start: June 19, 2024
• Primary Completion: April 14, 2025
• Study Completion: November 13, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)