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Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With 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: NCT03448978
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Cartesian Therapeutics

Tracking Information
First Submitted Date  ICMJE January 24, 2018
First Posted Date  ICMJE February 28, 2018
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE February 26, 2018
Estimated Primary Completion Date December 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 2 weeks ]
Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]. Descriptive statistics by incidence rate, body system classification, severity, and causality [per protocol definitions]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
Treatment response [ 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 Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma
Official Title  ICMJE 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
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.
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-08
    autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
    Other Name: CAR-T cells
  • Drug: Fludarabine
    intravenous fludarabine
  • Drug: Cyclophosphamide
    intravenous cyclophosphamide
Study Arms  ICMJE Experimental: Descartes-08 plus fludarabine/cyclophosphamide pretreat
Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
Interventions:
  • Biological: Descartes-08
  • 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 3, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: February 27, 2018)
15
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 for Clinical Trials 302-648-6497 trials@cartesiantx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03448978
Other Study ID Numbers  ICMJE 241-59-88
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
Study Director: Metin Kurtoglu, MD, PhD Cartesian Therapeutics
PRS Account Cartesian Therapeutics
Verification Date September 2020

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