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Interferon Beta-1A for B-cell Cancers

Phase 1 & 2

Waitlist Available

Led By Jordan Gauthier

Research Sponsored by Fred Hutchinson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 14 days after the last administration of interferon-beta-1a (fp-1201)

Awards & highlights

Study Summary

This trial is testing a medication to stop side effects of CD19 CAR T-cell therapy for B-cell cancers. It works by protecting blood vessels and preventing brain inflammation.

Who is the study for?

Adults with recurrent or refractory B-cell cancers eligible for specific CAR T-cell therapies can join this trial. They must be in relatively good health, understand the study, and agree to use effective birth control. People with severe allergies to interferon beta, significant kidney/liver/heart/pulmonary dysfunction, or uncontrolled infections cannot participate.Check my eligibility

What is being tested?

The trial is testing if Interferon-Beta-1a (FP-1201) given intravenously can prevent serious side effects after CD19-directed CAR T-cell therapy in patients with certain B-cell malignancies. It's a phase I/II trial focusing on safety and effectiveness of FP-1201.See study design

What are the potential side effects?

Interferon-Beta-1a may cause flu-like symptoms such as fever, chills, fatigue, muscle aches; it might also affect blood counts leading to anemia or increase infection risk. Some people could experience irritation at the injection site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 14 days after the last administration of interferon-beta-1a (fp-1201)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 14 days after the last administration of interferon-beta-1a (fp-1201)

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 14 days after the last administration of interferon-beta-1a (fp-1201) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting toxicity (DLT) rates

Incidence of adverse events (AEs)

Secondary outcome measures

Complete response rate

Cumulative corticosteroids dose

Cytokine release syndrome (CRS) rates

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prevention (interferon beta-1A [FP-1201])Experimental Treatment11 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Interferon Beta-1A

2018

Completed Phase 3

~1780

Echocardiography

2013

Completed Phase 4

~11670

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Positron Emission Tomography

2008

Completed Phase 2

~2240

Lumbar Puncture

2016

Completed Phase 3

~510

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Biopsy

2014

Completed Phase 4

~850

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,244 Total Patients Enrolled

Faron Pharmaceuticals LtdIndustry Sponsor

8 Previous Clinical Trials

782 Total Patients Enrolled

Jordan GauthierPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

4 Previous Clinical Trials

314 Total Patients Enrolled

Media Library

Prevention (interferon beta-1A [FP-1201]) Clinical Trial Eligibility Overview. Trial Name: NCT05936229 — Phase 1 & 2

Acute Lymphoblastic Leukemia Research Study Groups: Prevention (interferon beta-1A [FP-1201])

Acute Lymphoblastic Leukemia Clinical Trial 2023: Prevention (interferon beta-1A [FP-1201]) Highlights & Side Effects. Trial Name: NCT05936229 — Phase 1 & 2

Prevention (interferon beta-1A [FP-1201]) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05936229 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives does this trial hope to achieve?

"The primary goal of this trial, evaluated 14 days after the last interferon-beta-1a (FP-1201) administration, is to assess adverse event incidence. Secondary objectives include estimating cytokine release syndrome rates with American Society for Transplantation and Cellular Therapy criteria, calculating cumulative corticosteroid dose through descriptive statistics, and determining overall response rate according to Lugano criteria for B-non Hodgkin lymphoma patients or National Comprehensive Cancer Network guidelines for acute lymphoblastic leukemia participants."

Answered by AI

Are there vacancies available for potential participants in this research?

"As the information from clinicaltrials.gov displays, this medical trial is not actively looking for participants anymore as it was last updated on June 30th 2023. The study had been posted initially on December 1st 2023 but is now inactive; however, there are 3726 other studies that are presently open to new candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Interferon-Beta-1a (FP-1201) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy

2024. "Interferon-Beta-1a (FP-1201) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05936229.