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

NCT05936229 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2024-07-12

No results posted yet for this 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.

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

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

Sponsors & Collaborators

Principal Investigators

  • Jordan Gauthier · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2027-10-30
Completion
2027-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05936229 on ClinicalTrials.gov