Metoprolol Treatment for Cytokine Release Syndrome in Patients Treated With Chimeric Antigen Receptor T Cells

Chinese PLA General Hospital30 enrolled

Overview

The aim of this prospective study is to evaluate the feasibility and efficacy of metoprolol, a beta-1 adrenergic receptor blocker, in the treatment of cytokine release syndrome (CRS) caused by chimeric antigen receptor T (CAR T) cell infusions, its effects on the serum levels of Interleukin-6 (IL-6) and other cytokines.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumor Hematological Malignancy

Interventions

MetoprololDRUG

Metoprolol was given in patients who received CAR T cell therapy for CRS control or CRS precaution.

metoprolol, infliximab, etanercept, tocilizumab and/or other agentsDRUG

During the term of metoprolol use, antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited to be used under the consideration of clinical requirement for sufficient control of continuously progressed CRS.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with lymphoma, leukemia or other malignant diseases who were enrolled for CAR T cell therapy. Exclusion Criteria: Patients with contraindications indicated in metoprolol instruction, including: * Significant bradycardia (heart rate \< 45/min) * Cardiogenic shock * Severe or acute heart failure * Poor peripheral circulation perfusion * Grade II or III atrioventricular block * Sick sinus syndrome * Severe peripheral vascular disease

Locations (1)

Biotherapeutic Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Safety and tolerability of metoprolol in patients treated by CAR T infusions.

Reduction of heart rate in bpm (beats per minute)

Time frame: 2-4 weeks

Safety and tolerability of metoprolol in patients treated by CAR T infusions.

Reduction of blood pressure in mmHg

Time frame: 2-4 weeks

Secondary Outcomes

Efficacy of metoprolol for CRS control

Reduction of Body temperature in degree centigrade

Time frame: 2-4 weeks

Efficacy of metoprolol for CRS precaution

Reduction of serum IL-6 in pg/dl.

Time frame: 2-4 weeks

Central Contacts

Weidong Han, M.D.

CONTACT

+861066939711 hanwdrsw@sina.com

Data from ClinicalTrials.gov

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