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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03448978
Recruitment Status : Completed
First Posted : February 28, 2018
Last Update Posted : March 11, 2022
Sponsor:
Information provided by (Responsible Party):
Cartesian Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: Descartes-08 Drug: Fludarabine Drug: Cyclophosphamide Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 26, 2018
Actual Primary Completion Date : December 26, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Descartes-08 plus fludarabine/cyclophosphamide pretreat
Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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]


Secondary Outcome Measures :
  1. Treatment response [ Time Frame: 1, 3, 6, 9 and 12 months ]
    IMWG treatment response criteria


Eligibility Criteria
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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 (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
Contacts and Locations
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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): NCT03448978


Locations
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United States, Maryland
The Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Virginia
Virgina Cancer Specialists
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Cartesian Therapeutics
Investigators
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Study Director: Metin Kurtoglu, MD, PhD Cartesian Therapeutics
More Information
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Responsible Party: Cartesian Therapeutics
ClinicalTrials.gov Identifier: NCT03448978    
Other Study ID Numbers: 241-59-88
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: March 2022
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:
Descartes-08
CAR T Cell
CART
CAR-T
CAR T-Cell
 Multiple Myeloma
BCMA
B-cell maturation antigen
B cell maturation antigen
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