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

Recurrent Mantle Cell Lymphoma Clinical Trial

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

Status Not yet recruiting

Clinical 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 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Recurrence
• Recurrent B Acute Lymphoblastic Leukemia
• Recurrent B-Cell Non-Hodgkin Lymphoma
• Recurrent Mantle Cell Lymphoma
• Refractory B Acute Lymphoblastic Leukemia
• Refractory B-Cell Non-Hodgkin Lymphoma
• Refractory Mantle Cell Lymphoma

• NCT number: NCT05936229
• Study type: Interventional
• Source: Fred Hutchinson Cancer Center
• Contact: Fred Hutch Immunotherapy Intake
• Phone: 206-606-4668
• Email: immunotherapy@fredhutch.org
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 1, 2025
• Completion date: October 30, 2027