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Trial record 1 of 1 for:    NCT05113342
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Descartes-25 in Relapsed/Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05113342
Recruitment Status : Recruiting
First Posted : November 9, 2021
Last Update Posted : February 10, 2023
Sponsor:
Information provided by (Responsible Party):
Cartesian Therapeutics

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Relapse Multiple Myeloma Drug: Descartes-25 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/IIa Study of Descartes-25 in Patients With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date : November 25, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: DC-25


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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05113342


Contacts
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Contact: Hafsa Kamboh, MD 3013488698 Hafsa@cartesiantx.com
Contact: Milos Miljkovic, MD, MS milos@cartesiantx.com

Locations
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United States, Louisiana
Louisiana State University Health Science Center at Shreveport Recruiting
Shreveport, Louisiana, United States, 71103
Principal Investigator: Tamna Wangjam, M.D.         
United States, Maryland
Center for Cancer and Blood Disorders Recruiting
Bethesda, Maryland, United States, 20817
Contact: Investigator         
Turkey
Saglik Bilimleri Universitesi Recruiting
Ankara, Anatolia, Turkey, 06200
Principal Investigator: Fevzi Altuntas, MD         
Sponsors and Collaborators
Cartesian Therapeutics
More Information
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Responsible Party: Cartesian Therapeutics
ClinicalTrials.gov Identifier: NCT05113342    
Other Study ID Numbers: DC25-1A
First Posted: November 9, 2021    Key Record Dates
Last Update Posted: February 10, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cartesian Therapeutics:
myeloma
multiple myeloma
Relapse Refactory multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Recurrence
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes