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Descartes-11 in 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. Identifier: NCT03994705
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : April 13, 2020
Information provided by (Responsible Party):
Cartesian Therapeutics

Brief Summary:
This Phase I/2 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: Descartes-11 Drug: Fludarabine Drug: Cyclophosphamide Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date : August 6, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Dose-Escalation Biological: Descartes-11
CAR T-Cells

Drug: Fludarabine
Pre-conditioning chemotherapy

Drug: Cyclophosphamide
Pre-conditioning therapy

Primary Outcome Measures :
  1. Incidence (number) of Treatment-Emergent Adverse Events [ Time Frame: 14 Days ]
    Safety and Tolerability

Secondary Outcome Measures :
  1. Treatment Response [ Time Frame: Time Frame: 1, 3, 6, 9 and 12 months ]
    IMWG treatment response criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

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 identifier (NCT number): NCT03994705

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Contact: Cartesian Coordinator Clinical Trials 302-648-6497

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United States, Connecticut
Yale New Haven Hospital Not yet recruiting
New Haven, Connecticut, United States, 06510
Contact: Investigator    203-833-2701      
United States, Florida
Memorial Cancer Institute at Memorial Hospital West Recruiting
Pembroke Pines, Florida, United States, 33028
Contact: Investigator         
United States, Illinois
RUSH University Recruiting
Chicago, Illinois, United States, 60612
Contact: Investigator         
United States, Maryland
Center for Cancer and Blood Disorders Recruiting
Bethesda, Maryland, United States, 20817
Contact: Investigator         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Madison, Wisconsin, United States, 53226
Contact: Investigator         
Sponsors and Collaborators
Cartesian Therapeutics
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Responsible Party: Cartesian Therapeutics Identifier: NCT03994705    
Other Study ID Numbers: DC11A
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
CAR T Cell
CAR T-Cell
Multiple Myeloma
B cell maturation antigen
B-cell maturation antigen
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists