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Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy

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: NCT04816526
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
Cartesian Therapeutics

Brief Summary:
To assess Minimal Residual Disease (MRD)-negative Complete Response (sCR) rate after consolidation treatment with Descartes-08 in patients with high-risk myeloma who have residual disease following induction therapy.

Condition or disease Intervention/treatment Phase
Myeloma Multiple Biological: Descartes 08 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : February 25, 2023
Estimated Study Completion Date : March 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Descartes 08 Biological: Descartes 08
Car T-cells




Primary Outcome Measures :
  1. Rate of stringent complete response [ Time Frame: 2 years ]


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:

  • Patients must be 18 years of age or older at the time of enrollment
  • High-risk multiple myeloma patients who complete pre-transplant induction treatment anti- myeloma drug combination (minimum 2 drugs).

Exclusion Criteria:

  • Patients who are pregnant or lactating.
  • Patients who have any active and uncontrolled infection. No blood cultures are necessary unless clinically indicated.

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): NCT04816526


Contacts
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Contact: Adam Chowdhury, MD, MBA 3013488698 adam.chowdhury@cartesiantx.com

Locations
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United States, California
University of California Irvine Recruiting
Orange, California, United States, 92868
Contact: UCI Study team         
Contact    1-877-UC -STUDY    ucstudy@uci.edu   
Principal Investigator: Stefan Ciurea, MD         
United States, Tennessee
Sarah Cannon Research Institute at Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Sarah Ladd    615-524-4133    Sarah.Ladd@sarahcannon.com   
Principal Investigator: Jesus G Berdeja, MD         
Sponsors and Collaborators
Cartesian Therapeutics
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Responsible Party: Cartesian Therapeutics
ClinicalTrials.gov Identifier: NCT04816526    
Other Study ID Numbers: DC-08-B
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
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