Study Stopped
Study closed before opening to accrual, no participants enrolled
Interferon-Beta-1a (FP-1201) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy
Phase 1/2 Study to Evaluate the Safety, Feasibility, and Efficacy of FP-1201 (Intravenous Interferon-Beta-1a) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy
3 other identifiers
interventional
N/A
1 country
1
Brief Summary
This phase I/II trial tests the safety and how well intravenous interferon-beta-1a (FP-1201) works in preventing toxicities after CD19-directed chimeric antigen receptor (CAR) T-cell therapy in patients with B-cell cancers that has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory). Interferon beta-1a is in a class of medications called immunomodulators. It works by protecting the lining of blood vessels, and preventing brain inflammation. Giving FP-1201 may prevent cytokine release syndrome (CRS) and immune effector cell associated-neurotoxicity syndrome (ICANS) toxicities in patients receiving CD19 CAR T-cell therapy with recurrent or refractory B-cell malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2025
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2023
CompletedFirst Posted
Study publicly available on registry
July 7, 2023
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2027
July 12, 2024
May 1, 2024
2.6 years
June 30, 2023
July 10, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Dose-limiting toxicity (DLT) rates
Will be summarized in the DLT evaluable population. Final DLT rates at each dose level will be estimated by isotonic regression by applying the pooled adjacent violators algorithm. The target toxicity rate is 30%.
Within 14 days after the last administration of interferon-beta-1a (FP-1201)
Incidence of adverse events (AEs)
Type, frequency, and severity of AEs according to the National Cancer Institutes Common Terminology Criteria for Adverse Events version 5.0.
From the first dose of FP-1201 through day 28 after chimeric antigen receptor (CAR) T-cell infusion
Secondary Outcomes (5)
Cytokine release syndrome (CRS) rates
From the time of CAR T-cell infusion through day 28 after CAR T-cell infusion or until resolution, whichever happens last
Immune effector cell associated-neurotoxicity syndrome (ICANS) rates
From the time of CAR T-cell infusion through day 28 after CAR T-cell infusion or until resolution, whichever happens last
Cumulative corticosteroids dose
Within 28 days after CAR T-cell infusion
Overall response rate
28 days after CAR T-cell infusion
Complete response rate
28 days after CAR T-cell infusion
Study Arms (1)
Prevention (interferon beta-1A [FP-1201])
EXPERIMENTALPatients 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.
Interventions
Given IV
Undergo x-ray
Undergo MUGA
Undergo CT
Undergo PET/CT
Undergo LP
Undergo bone marrow aspiration
Undergo blood and CSF sample collection
Undergo tissue biopsy
Eligibility Criteria
You may qualify if:
- Participants must be 18 years of age or older
- 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
You may not qualify if:
- Known hypersensitivity to natural or recombinant interferon beta, albumin or any other component of the formulation
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fred Hutchinson Cancer Centerlead
- Faron Pharmaceuticals Ltdcollaborator
Study Sites (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jordan Gauthier
Fred Hutch/University of Washington Cancer Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2023
First Posted
July 7, 2023
Study Start
April 1, 2025
Primary Completion (Estimated)
October 30, 2027
Study Completion (Estimated)
October 30, 2027
Last Updated
July 12, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share