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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.
 
ClinicalTrials.gov Identifier: NCT03994705
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Cartesian Therapeutics

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
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 2019
Estimated Study Completion Date : December 2020

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

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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:

  • 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 ClinicalTrials.gov identifier (NCT number): NCT03994705


Contacts
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Contact: Cartesian Coordinator Clinical Trials 302-648-6497 trials@cartesiantx.com

Locations
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United States, Florida
Memorial Cancer Institute at Memorial Hospital West Not yet recruiting
Pembroke Pines, Florida, United States, 33028
Contact: Jose Sandoval-Sus, MD         
United States, Illinois
RUSH University Recruiting
Chicago, Illinois, United States, 60612
Contact: Celalettin Ustun, MD         
United States, Maryland
Center for Cancer and Blood Disorders Recruiting
Bethesda, Maryland, United States, 20817
Contact: Ralph Boccia, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Madison, Wisconsin, United States, 53226
Contact: Binod Dhakal, MD         
Sponsors and Collaborators
Cartesian Therapeutics

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Responsible Party: Cartesian Therapeutics
ClinicalTrials.gov Identifier: NCT03994705     History of Changes
Other Study ID Numbers: DC11A
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
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
CART
CAR T Cell
CAR T-Cell
Multiple Myeloma
BCMA
B cell maturation antigen
B-cell maturation antigen
Descartes-11
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
Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists