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Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Descartes-08
Fludarabine
Cyclophosphamide
Sponsored by
Cartesian Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Descartes-08, CAR T Cell, CART, CAR-T, CAR T-Cell, Multiple Myeloma, BCMA, B-cell maturation antigen, B cell maturation antigen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (condensed):

  • Multiple myeloma that is double-refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) after at least 2 prior lines of therapy OR have failed at least 3 prior lines of therapy
  • Measurable disease activity as indicated by serum or urine M-protein, serum free light chain, biopsy-proven plasmacytoma, >5% bone marrow plasma cells.
  • Adequate vital organ function as indicated by ANC (>1000/uL), platelet count (>50,000/uL), hemoglobin (>8 g/dL), serum ALT and AST (each <3.0 x upper limit of normal), total bilirubin (<2 mg/dL), creatinine clearance (>30 mL/min), and cardiac ejection fraction (>45%)

Exclusion Criteria (condensed):

NOTE: Prior anti-BCMA or CAR-T therapy is NOT exclusionary

  • Active plasma cell leukemia
  • Pregnant or lactating
  • Active, uncontrolled infection
  • Active and severe auto-immune disease
  • Active arrhythmia, or obstructive or restrictive pulmonary disease
  • Central nervous system disease

Sites / Locations

  • The Center for Cancer and Blood Disorders
  • University of Oklahoma Health Sciences Center
  • Virgina Cancer Specialists

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Descartes-08 plus fludarabine/cyclophosphamide pretreat

Arm Description

Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor

Outcomes

Primary Outcome Measures

Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]. Descriptive statistics by incidence rate, body system classification, severity, and causality [per protocol definitions]

Secondary Outcome Measures

Treatment response
IMWG treatment response criteria

Full Information

First Posted
January 24, 2018
Last Updated
March 10, 2022
Sponsor
Cartesian Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03448978
Brief Title
Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma
Official Title
Combined Phase I-Phase II Study of Autologous CD8+ T-cells Transiently Expressing a Chimeric Antigen Receptor Directed to B-Cell Maturation Antigen in Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
December 26, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

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/II study will test the safety and anti-myeloma activity of ascending doses of Descartes-08 (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
Descartes-08, CAR T Cell, CART, CAR-T, CAR T-Cell, Multiple Myeloma, BCMA, B-cell maturation antigen, B cell maturation antigen

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
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Descartes-08 plus fludarabine/cyclophosphamide pretreat
Arm Type
Experimental
Arm Description
Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
Intervention Type
Biological
Intervention Name(s)
Descartes-08
Other Intervention Name(s)
CAR-T cells
Intervention Description
autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
intravenous fludarabine
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
intravenous cyclophosphamide
Primary Outcome Measure Information:
Title
Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]. Descriptive statistics by incidence rate, body system classification, severity, and causality [per protocol definitions]
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Treatment response
Description
IMWG treatment response criteria
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 (condensed): Multiple myeloma that is double-refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) after at least 2 prior lines of therapy OR have failed at least 3 prior lines of therapy Measurable disease activity as indicated by serum or urine M-protein, serum free light chain, biopsy-proven plasmacytoma, >5% bone marrow plasma cells. Adequate vital organ function as indicated by ANC (>1000/uL), platelet count (>50,000/uL), hemoglobin (>8 g/dL), serum ALT and AST (each <3.0 x upper limit of normal), total bilirubin (<2 mg/dL), creatinine clearance (>30 mL/min), and cardiac ejection fraction (>45%) Exclusion Criteria (condensed): NOTE: Prior anti-BCMA or CAR-T therapy is NOT exclusionary Active plasma cell leukemia Pregnant or lactating Active, uncontrolled infection Active and severe auto-immune disease Active arrhythmia, or obstructive or restrictive pulmonary disease Central nervous system disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Metin Kurtoglu, MD, PhD
Organizational Affiliation
Cartesian Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
The Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Virgina Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma

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