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Recurrent B Acute Lymphoblastic LeukemiaPhase 1/2NCT05936229

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

A Phase 1/2 study testing Interferon Beta-1A, X-Ray Imaging and Echocardiography in people with Recurrent B Acute Lymphoblastic Leukemia and Recurrent B-Cell Non-Hodgkin Lymphoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Interferon Beta-1A, X-Ray Imaging and Echocardiography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Apr 2025to 30 Oct 2027
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

OUTLINE: This is a dose-escalation study of FP-1201.

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.

Being tested
Interferon Beta-1A, X-Ray Imaging, Echocardiography, Multigated Acquisition Scan, Computed Tomography
Medical subject headings
Burkitt Lymphoma, Lymphoma, B-Cell, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interferon Beta-1ABiological

    Also called 145258-61-3, Avonex, BG9418, Rebif

    Given IV

  • X-Ray ImagingProcedure or surgery

    Also called Conventional X-Ray, Diagnostic Radiology, Medical Imaging, Plain film radiographs

    Undergo x-ray

  • EchocardiographyProcedure or surgery

    Also called EC

    Undergo ECHO

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan

    Undergo MUGA

  • Computed TomographyProcedure or surgery

    Also called CAT Scan, Computed Axial Tomography, Computerized axial tomography (procedure)

    Undergo CT

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Pet Scan, Positron emission tomography (procedure), Positron-Emission Tomography

    Undergo PET/CT

  • Lumbar PunctureProcedure or surgery

    Also called LP, spinal tap

    Undergo LP

  • Bone Marrow AspirationProcedure or surgery

    Undergo bone marrow aspiration

  • Bone Marrow BiopsyProcedure or surgery

    Undergo bone marrow biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection

    Undergo blood and CSF sample collection

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo tissue biopsy

Study groups in NCT05936229
Study groupRoleWhat they receive
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.
Receives: Biological: Interferon Beta-1A; Procedure: X-Ray Imaging; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Procedure: Lumbar Puncture; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Biospecimen Collection; Procedure: Biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%.

    Measured: Within 14 days after the last administration of interferon-beta-1a (FP-1201)

  2. 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.

    Measured: From the first dose of FP-1201 through day 28 after chimeric antigen receptor (CAR) T-cell infusion

Secondary outcomes (5)

  1. Cytokine release syndrome (CRS) rates

    Will be assessed by any grade and grade >= 3 by American Society for Transplantation and Cellular Therapy (ASTCT) criteria and will be summarized along the two-sided 95% Clopper-Pearson confidence interval (CI) based on the CRS and ICANS analysis set.

    Measured: From the time of CAR T-cell infusion through day 28 after CAR T-cell infusion or until resolution, whichever happens last

  2. Immune effector cell associated-neurotoxicity syndrome (ICANS) rates

    Will be assessed by any grade and grade >= 3 by ASTCT criteria and will be summarized along the two-sided 95% Clopper-Pearson CI based on the CRS and ICANS analysis set.

    Measured: From the time of CAR T-cell infusion through day 28 after CAR T-cell infusion or until resolution, whichever happens last

  3. Cumulative corticosteroids dose

    Will be summarized using descriptive statistics (median, quantiles) based on the CRS and ICANS analysis set.

    Measured: Within 28 days after CAR T-cell infusion

  4. Overall response rate

    Will be assessed by the Lugano criteria for B-non-Hodgkin lymphoma (NHL) participants and National Comprehensive Cancer Network (NCCN) criteria for B- acute lymphoblastic leukemia (ALL) participants Will be summarized along with the two-sided Clopper-Pearson CI based on the anti-tumor response evaluable analysis set.

    Measured: 28 days after CAR T-cell infusion

  5. Complete response rate

    Will be assessed by the Lugano criteria for B-NHL participants and NCCN criteria for B-ALL participants Will be summarized along with the two-sided Clopper-Pearson CI based on the anti-tumor response evaluable analysis set.

    Measured: 28 days after CAR T-cell infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2023
  2. Study start1 Apr 2025 (estimated)
  3. Primary completion30 Oct 2027 (estimated)
  4. Study completion30 Oct 2027 (estimated)

Why it stopped: Study closed before opening to accrual, no participants enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05936229
Sponsor's protocol ID
RG1123521
Other IDs
NCI-2023-04888, 20021
Status last verified
May 2024
First submitted
30 Jun 2023
Last updated
12 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Interferon Beta-1A, X-Ray Imaging and Echocardiography in people with Recurrent B Acute Lymphoblastic Leukemia and Recurrent B-Cell Non-Hodgkin Lymphoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) rates (time frame: Within 14 days after the last administration of interferon-beta-1a (FP-1201)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05936229.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.

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