Descartes-25 in Relapsed/Refractory Multiple Myeloma

November 8, 2024 updated by: Cartesian Therapeutics

Phase I/IIa Study of Descartes-25 in Patients With Relapsed/Refractory Multiple Myeloma

This is a Phase I/IIa dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of an allogeneic Mesenchymal Stem Cell (Descartes-25) product secreting a bispecific protein and other proteins in patients with Relapsed/Refractory Multiple Myeloma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

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

  • Turkey
    • Anatolia
      • Ankara, Anatolia, Turkey, 06200
        • Saglik Bilimleri Universitesi
  • United States
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Louisiana State University Health Science Center at Shreveport
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders

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:

  • 18 years and older'
  • diagnosed with active R/RMM, who have failed 2 lines of treatment
  • have measurable disease

Exclusion Criteria:

- Patients with active plasma cell leukemia

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: Arm 1: Dose Level 1
Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached.
Drug: Descartes-25
allogeneic Mesenchymal Stem Cell product.
Other Names:
  • DC-25
Experimental: Arm 2: Dose Level 2
Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached.
Drug: Descartes-25
allogeneic Mesenchymal Stem Cell product.
Other Names:
  • DC-25
Experimental: Arm 3: Dose Level 3
Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached.
Drug: Descartes-25
allogeneic Mesenchymal Stem Cell product.
Other Names:
  • DC-25
Experimental: Arm 4: Dose Expansion
In Arm 2, the MTD established in Arm 1 will be administered for 3 28-day cycles to further evaluate the product's safety and preliminary efficacy.
Drug: Descartes-25
allogeneic Mesenchymal Stem Cell product.
Other Names:
  • DC-25

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose
Time Frame: 1 Year
Dose Level at which no more than 20% of the patients treated have shown Dose-Limiting Toxicity.
1 Year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate according to the IMWG response criteria
Time Frame: 1 Year
1 Year
Median Duration of Response
Time Frame: 1 Year
1 Year

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 (Actual)

November 25, 2021

Primary Completion (Actual)

May 9, 2023

Study Completion (Actual)

November 8, 2024

Study Registration Dates

First Submitted

October 19, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

November 9, 2021

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 8, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC25-1A

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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