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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04082910

Enrollment

Registered

2019-09-10

Start date

2019-09-15

Completion date

2023-12-30

Last updated

2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological Malignancy, Solid Tumor

Keywords

Metoprolol, cytokine release syndrome, chimeric antigen receptor T cells

Brief 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.

Interventions

DRUGMetoprolol

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

DRUGmetoprolol, 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability of metoprolol in patients treated by CAR T infusions.	2-4 weeks	Reduction of heart rate in bpm (beats per minute)

Secondary

Measure	Time frame	Description
Efficacy of metoprolol for CRS control	2-4 weeks	Reduction of Body temperature in degree centigrade
Efficacy of metoprolol for CRS precaution	2-4 weeks	Reduction of serum IL-6 in pg/dl.

Countries

China

Contacts

Primary ContactWeidong Han, M.D.

hanwdrsw@sina.com+861066939711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026