NCT05936229

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Recurrent B Acute Lymphoblastic Leukemia
• Recurrent B-Cell Non-Hodgkin Lymphoma
• Refractory B Acute Lymphoblastic Leukemia
• Refractory B-Cell Non-Hodgkin Lymphoma
• Recurrent Mantle Cell Lymphoma
• Refractory Mantle Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Interferon Beta-1A	Given IV
PROCEDURE	X-Ray Imaging	Undergo x-ray
PROCEDURE	Echocardiography	Undergo ECHO
PROCEDURE	Multigated Acquisition Scan	Undergo MUGA
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Positron Emission Tomography	Undergo PET/CT
PROCEDURE	Lumbar Puncture	Undergo LP
PROCEDURE	Bone Marrow Aspiration	Undergo bone marrow aspiration
PROCEDURE	Bone Marrow Biopsy	Undergo bone marrow biopsy
PROCEDURE	Biospecimen Collection	Undergo blood and CSF sample collection
PROCEDURE	Biopsy	Undergo tissue biopsy

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-10-30
• Completion: 2027-10-30
• First posted: 2023-07-07
• Last updated: 2024-07-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study