Interferon-Beta-1a (FP-1201) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy
NCT ID: NCT05936229
Last Updated: 2024-07-12
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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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2025-04-01
2027-10-30
Brief Summary
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Detailed Description
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Patients undergo leukapheresis prior to treatment and receive FP-1201 intravenously (IV) for 3 days every 24 hours from day -3 through day -1 or for 5 days every 24 hours from day -5 through day -1 or on day -5, day -3, and day -1. Patients may receive lymphodepletion chemotherapy with either cyclophosphamide IV and fludarabine IV on days -5, -4, -3 followed by axi-cel IV or brexu-cel IV on day 0 or fludarabine IV over 30 minutes on days -4, -3, and -2 and cyclophosphamide IV over 60 minutes on day -2 followed by brexu-cel IV on day 0. Patients undergo x-ray imaging and echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients also undergo computed tomography (CT) or positron emission tomography (PET)/CT as well as lumbar puncture (LP) for cerebral spinal fluid (CSF) collection and/or bone marrow aspiration and biopsy as clinically indicated during screening and follow-up. Patients undergo blood sample collection on study and during follow-up as well as a tissue biopsy during screening and follow-up.
After completion of study treatment, patients are followed up to 28 days and 90 days, then long-term for up to 15 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Prevention (interferon beta-1A [FP-1201])
Patients undergo leukapheresis prior to treatment and receive FP-1201 IV for 3 days every 24 hours from day -3 through day -1 or for 5 days every 24 hours from day -5 through day -1 or on day -5, day -3, and day -1. Patients may receive lymphodepletion chemotherapy with either cyclophosphamide IV and fludarabine IV on days -5, -4, -3 followed by axi-cel IV or brexu-cel IV on day 0 or fludarabine IV over 30 minutes on days -4, -3, and -2 and cyclophosphamide IV over 60 minutes on day -2 followed by brexu-cel IV on day 0. Patients undergo x-ray imaging and ECHO or MUGA during screening. Patients also undergo CT or PET/CT as well as LP for CSF collection and/or bone marrow aspiration and biopsy as clinically indicated during screening and follow-up. Patients undergo blood sample collection on study and during follow-up as well as a tissue biopsy during screening and follow-up.
Interferon Beta-1A
Given IV
X-Ray Imaging
Undergo x-ray
Echocardiography
Undergo ECHO
Multigated Acquisition Scan
Undergo MUGA
Computed Tomography
Undergo CT
Positron Emission Tomography
Undergo PET/CT
Lumbar Puncture
Undergo LP
Bone Marrow Aspiration
Undergo bone marrow aspiration
Bone Marrow Biopsy
Undergo bone marrow biopsy
Biospecimen Collection
Undergo blood and CSF sample collection
Biopsy
Undergo tissue biopsy
Interventions
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Interferon Beta-1A
Given IV
X-Ray Imaging
Undergo x-ray
Echocardiography
Undergo ECHO
Multigated Acquisition Scan
Undergo MUGA
Computed Tomography
Undergo CT
Positron Emission Tomography
Undergo PET/CT
Lumbar Puncture
Undergo LP
Bone Marrow Aspiration
Undergo bone marrow aspiration
Bone Marrow Biopsy
Undergo bone marrow biopsy
Biospecimen Collection
Undergo blood and CSF sample collection
Biopsy
Undergo tissue biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Karnofsky performance status of \>= 60%
* Participants eligible for treatment with axi-cel or brexu-cel
* Negative serum pregnancy test within 2 weeks of enrollment for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year
* Fertile male and female participants must be willing to use an effective contraceptive method before, during, and for at least 4 months after the last dose of FP-1201
* Ability to understand and provide informed consent
Exclusion Criteria
* Estimated creatinine clearance (Cockcroft and Gault) =\< 60 mL/min
* Significant proteinuria defined as 2+ or 3+ proteinuria or urinary protein \>= 1g/24h
* Severe hepatic dysfunction defined as group C of the National Cancer Institute Organ Dysfunction Working Group hepatic impairment criteria (total bilirubin \> 3x upper limit of normal \[ULN\] with any aspartate aminotransferase \[AST\] or alanine transaminase \[AL\]T value), or AST or ALT \> 3x ULN, unless due to malignancy or Gilbert's syndrome in the opinion of the principal investigator (PI) or designee
* Participants with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing, as clinically indicated. Those with an forced expiratory volume in the first second (FEV1) of \< 50 % of predicted or diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected) \< 40% will be excluded
* Significant cardiovascular abnormalities as defined by any one of the following:
* New York Heart Association (NYHA) class III or IV congestive heart failure, clinically significant hypotension
* Uncontrolled symptomatic coronary artery disease, or a documented ejection fraction of \< 35%
* Uncontrolled serious and active infection
* Corticosteroid use (\> 20mg/day of prednisone, or equivalent) within 7 days prior to first FP-1201 administration
18 Years
ALL
No
Sponsors
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Faron Pharmaceuticals Ltd
INDUSTRY
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jordan Gauthier
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2023-04888
Identifier Type: REGISTRY
Identifier Source: secondary_id
20021
Identifier Type: OTHER
Identifier Source: secondary_id
RG1123521
Identifier Type: -
Identifier Source: org_study_id
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