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

March 8, 2024 updated by: Cartesian Therapeutics
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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Day -60 to Month 12
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
Time Frame: Day 1 to Month 12
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

This is where you will find people and organizations involved with this study.

Sponsor

Cartesian Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

October 1, 2027

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)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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