Study on Using Siltuximab to Treat Side Effects of CAR-T Cell Therapy

Sponsor: University of Alabama at Birmingham

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04975555

Provider View

This clinical trial is testing whether the drug siltuximab can help reduce the severity of certain side effects, like cytokine release syndrome (CRS) and neurological issues, in patients receiving CAR-T cell therapy for blood cancers.

Patient Parameters

Program Overview

The study aims to find out if siltuximab can lessen the severity of cytokine release syndrome (CRS) and immune-related neurological problems in patients undergoing CAR-T cell therapy for blood cancers. Participants will be monitored for these side effects, and if they occur, siltuximab will be given to help manage the symptoms.

Description

Patients who are eligible for CAR T-cell therapy for certain blood cancers will be enrolled in this study on the day they receive their CAR T-cell infusion. They will be monitored for any development of side effects like CRS or neurological issues. If these side effects occur, siltuximab will be administered, and patients will be closely monitored to see if symptoms improve. If symptoms do not improve, an additional dose of siltuximab may be given, and if necessary, another medication called tocilizumab will be used. The main goal of the study is to see how well siltuximab works in resolving CRS within 14 days. The study will also look at how well siltuximab works for neurological issues, its safety, and the overall effectiveness of CAR T-cell therapy.

Eligibility Criteria

Inclusion Criteria

  • Patients planning to receive CAR T-cell therapy for certain blood cancers like Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, and others.
  • Patients with treated hepatitis C or controlled hepatitis B with no detectable virus.
  • Good organ function, including liver, kidney, and blood cell counts, within 7 to 30 days before CAR T-cell infusion.
  • Able to stop certain treatments before CAR T-cell infusion: 2 weeks for systemic therapy, 1 week for radiation, and 5 days for corticosteroids.
  • Negative pregnancy test for women of childbearing potential within 1 week before joining the study.
  • Use of effective birth control for women and men during the study and for a specified time after treatment.
  • Willingness to participate in all study procedures, including receiving the study drug and staying in the hospital if needed.

Exclusion Criteria

  • Need for daily corticosteroid treatment above a certain dose.
  • Active autoimmune disease requiring immunosuppressive treatment, unless approved by the study lead.
  • Pregnant women cannot participate.
  • Ongoing serious infections, except minor skin or nail infections.
  • Current or past HIV infection.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.