Back to resultsDescartes-11 in Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Descartes-11
Fludarabine
Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring CAR-T, CART, CAR T Cell, CAR T-Cell, Multiple Myeloma, BCMA, B cell maturation antigen, B-cell maturation antigen, Descartes-11
Eligibility 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.
Sites / Locations
- Center for Cancer and Blood Disorders
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose-Escalation
Arm Description
Outcomes
Primary Outcome Measures
Incidence (number) of Treatment-Emergent Adverse Events
Safety and Tolerability
Secondary Outcome Measures
Treatment Response
IMWG treatment response criteria
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03994705
Brief Title
Descartes-11 in Multiple Myeloma
Official Title
Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 6, 2019 (Actual)
Primary Completion Date
February 6, 2024 (Anticipated)
Study Completion Date
February 6, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cartesian Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
CAR-T, CART, CAR T Cell, CAR T-Cell, Multiple Myeloma, BCMA, B cell maturation antigen, B-cell maturation antigen, Descartes-11
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose-Escalation
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Descartes-11
Intervention Description
CAR T-Cells
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Pre-conditioning chemotherapy
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Pre-conditioning therapy
Primary Outcome Measure Information:
Title
Incidence (number) of Treatment-Emergent Adverse Events
Description
Safety and Tolerability
Time Frame
14 Days
Secondary Outcome Measure Information:
Title
Treatment Response
Description
IMWG treatment response criteria
Time Frame
Time Frame: 1, 3, 6, 9 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Medical College of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Descartes-11 in Multiple Myeloma
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