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出境医 / 临床实验 / Descartes-11 in Multiple Myeloma

Descartes-11 in Multiple Myeloma

Study Description
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

Study Design
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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 2021
Estimated Study Completion Date : December 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Dose-Escalation Biological: Descartes-11
CAR T-Cells

Drug: Fludarabine
Pre-conditioning chemotherapy

Drug: Cyclophosphamide
Pre-conditioning therapy
Outcome Measures
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


Eligibility Criteria
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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.
Contacts and Locations

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

Locations
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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
Tracking Information
First Submitted Date  ICMJE June 19, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date February 10, 2021
Actual Study Start Date  ICMJE August 6, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019) 		Incidence (number) of Treatment-Emergent Adverse Events [ Time Frame: 14 Days ]
Safety and Tolerability
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2019) 		Treatment Response [ Time Frame: Time Frame: 1, 3, 6, 9 and 12 months ]
IMWG treatment response criteria
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Descartes-11 in Multiple Myeloma
Official Title  ICMJE Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Biological: Descartes-11
    CAR T-Cells
  • Drug: Fludarabine
    Pre-conditioning chemotherapy
  • Drug: Cyclophosphamide
    Pre-conditioning therapy
Study Arms  ICMJE Experimental: Dose-Escalation
Interventions:
  • Biological: Descartes-11
  • Drug: Fludarabine
  • Drug: Cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2019) 		18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cartesian Coordinator Clinical Trials 302-648-6497 trials@cartesiantx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03994705
Other Study ID Numbers  ICMJE DC11A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cartesian Therapeutics
Study Sponsor  ICMJE Cartesian Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cartesian Therapeutics
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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