Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma
NCT ID: NCT03448978
Last Updated: 2024-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
32 participants
INTERVENTIONAL
2018-03-08
2021-06-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Descartes-08 plus fludarabine/cyclophosphamide pretreat
Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
Descartes-08
autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
Fludarabine
intravenous fludarabine
Cyclophosphamide
intravenous cyclophosphamide
Interventions
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Descartes-08
autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
Fludarabine
intravenous fludarabine
Cyclophosphamide
intravenous cyclophosphamide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Cartesian Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Metin Kurtoglu, MD, PhD
Role: STUDY_DIRECTOR
Cartesian Therapeutics
Locations
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The Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Virgina Cancer Specialists
Fairfax, Virginia, United States
Countries
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Other Identifiers
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241-59-88
Identifier Type: -
Identifier Source: org_study_id
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