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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Solid Tumor; Hematological Malignancy

Treatments: Drug: Metoprolol; Drug: metoprolol, infliximab, etanercept, tocilizumab and/or other agents

Study type: Interventional

Funder types: Other

Identifiers

NCT04082910

CHN-PLAGH-BT-044

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Conditional therapy mode group

Experimental group

Description:

Metoprolol (12.5-25 mg per dose, every 12 hours) was initially given from the day of CRS diagnosis confirmation post CAR T cell infusions till CRS remission in patients without bulky tumor burden. For all metoprolol-treated patients, the use of antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited under the consideration of clinical requirement for sufficient control of continuously progressed CRS.

Treatment:

Drug: Metoprolol

Drug: metoprolol, infliximab, etanercept, tocilizumab and/or other agents

Prophylactic therapy mode group

Experimental group

Description:

Metoprolol (12.5-25 mg per dose, every 12 hours) was given starting from the day before CAR T infusion till CRS remission in patients with bulky disease. For all metoprolol-treated patients, the use of antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited under the consideration of clinical requirement for sufficient control of continuously progressed CRS.

Treatment:

Drug: Metoprolol

Drug: metoprolol, infliximab, etanercept, tocilizumab and/or other agents