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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04082910
• Other study ID #: CHN-PLAGH-BT-044
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 15, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2022
• Source: Chinese PLA General Hospital
• Contact: Weidong Han, M.D.
• Phone: +861066939711
• Email: hanwdrsw[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cytokine Release Syndrome
• Hematologic Neoplasms
• Hematological Malignancy
• Solid Tumor

Intervention

Drug:
• Metoprolol
Metoprolol was given in patients who received CAR T cell therapy for CRS control or CRS precaution.
• metoprolol, infliximab, etanercept, tocilizumab and/or other agents
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.

Locations

Country	Name	City	State
China	Biotherapeutic Department of Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of metoprolol in patients treated by CAR T infusions.	Reduction of heart rate in bpm (beats per minute)	2-4 weeks
Primary	Safety and tolerability of metoprolol in patients treated by CAR T infusions.	Reduction of blood pressure in mmHg	2-4 weeks
Secondary	Efficacy of metoprolol for CRS control	Reduction of Body temperature in degree centigrade	2-4 weeks
Secondary	Efficacy of metoprolol for CRS precaution	Reduction of serum IL-6 in pg/dl.	2-4 weeks