Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

April 30, 2025 updated by: Cartesian Therapeutics

Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

This Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-11 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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 Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders
    • Wisconsin
      • Madison, Wisconsin, United States, 53226
        • Medical College of Wisconsin

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Active multiple myeloma that is refractory after at least 2 prior lines of therapy;
  • measurable disease;
  • adequate vital organ function; and
  • no active infection.

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Level 1

Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3

Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7,14
Biological: Descartes-11
CAR T-Cells
Drug: Fludarabine
Pre-conditioning chemotherapy
Drug: Cyclophosphamide
Pre-conditioning therapy
Experimental: Dose Level 2

Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3

Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7,14
Biological: Descartes-11
CAR T-Cells
Drug: Fludarabine
Pre-conditioning chemotherapy
Drug: Cyclophosphamide
Pre-conditioning therapy
Experimental: Dose Level 3

Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3

Participants were administered 100 million cells of Descartes-11 via intravenous catheter on Days 7,14
Biological: Descartes-11
CAR T-Cells
Drug: Fludarabine
Pre-conditioning chemotherapy
Drug: Cyclophosphamide
Pre-conditioning therapy
Experimental: Dose Level 4 A

Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3

Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,14,21
Biological: Descartes-11
CAR T-Cells
Drug: Fludarabine
Pre-conditioning chemotherapy
Drug: Cyclophosphamide
Pre-conditioning therapy
Experimental: Dose Level 4B

Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3

Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,21
Biological: Descartes-11
CAR T-Cells
Drug: Fludarabine
Pre-conditioning chemotherapy
Drug: Cyclophosphamide
Pre-conditioning therapy
Experimental: Dose Level 4C

Participants were not administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3

Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 1,4, 7,10,14,21
Biological: Descartes-11
CAR T-Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Related Adverse Events
Time Frame: Time Frame: 21 days
Determine the safety of Descartes-11 in patients with relapsed/refractory multiple myeloma
Time Frame: 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Assessment Based on International Myeloma Working Group (IMWG) Criteria
Time Frame: Disease assessment is on Day 21 (or at least 14 days after first Descartes-11 infusion)
Patience with Complete response (CR) according to the International Myeloma Working Group (IMWG).
Disease assessment is on Day 21 (or at least 14 days after first Descartes-11 infusion)

Collaborators and Investigators

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

Sponsor

Cartesian Therapeutics

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 1, 2019

Primary Completion (Actual)

May 27, 2021

Study Completion (Actual)

June 11, 2021

Study Registration Dates

First Submitted

June 19, 2019

First Submitted That Met QC Criteria

June 19, 2019

First Posted (Actual)

June 21, 2019

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC11A
  • 5R44CA221432-03 (U.S. NIH Grant/Contract)

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.

Clinical Trials on Multiple Myeloma

Clinical Trials on Descartes-11

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe