NCT05936229

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

Study 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.

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Interventions

Interferon Beta-1ABIOLOGICAL
Given IV
X-Ray ImagingPROCEDURE
Undergo x-ray
EchocardiographyPROCEDURE
Undergo ECHO
Multigated Acquisition ScanPROCEDURE
Undergo MUGA
Computed TomographyPROCEDURE
Undergo CT
Positron Emission TomographyPROCEDURE
Undergo PET/CT
Lumbar PuncturePROCEDURE
Undergo LP
Bone Marrow AspirationPROCEDURE
Undergo bone marrow aspiration
Bone Marrow BiopsyPROCEDURE
Undergo bone marrow biopsy
Biospecimen CollectionPROCEDURE
Undergo blood and CSF sample collection
BiopsyPROCEDURE
Undergo tissue biopsy

Study Locations

FacilityCityStateCountry
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashingtonUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026