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

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04082910
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
51.5
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Metoprolol
  • Drug: metoprolol, infliximab, etanercept, tocilizumab and/or other agents
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Metoprolol for the Treatment of Cytokine Release Syndrome in Patients Treated With Chimeric Antigen Receptor T Cells
Actual Study Start Date :
Sep 15, 2019
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Conditional therapy mode group

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.

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

Drug: 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.
Experimental: Prophylactic therapy mode group

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.

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

Drug: 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.

Outcome Measures

Primary Outcome Measures

  1. Safety and tolerability of metoprolol in patients treated by CAR T infusions. [2-4 weeks]

    Reduction of heart rate in bpm (beats per minute)

  2. Safety and tolerability of metoprolol in patients treated by CAR T infusions. [2-4 weeks]

    Reduction of blood pressure in mmHg

Secondary Outcome Measures

  1. Efficacy of metoprolol for CRS control [2-4 weeks]

    Reduction of Body temperature in degree centigrade

  2. Efficacy of metoprolol for CRS precaution [2-4 weeks]

    Reduction of serum IL-6 in pg/dl.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Biotherapeutic Department of Chinese PLA General Hospital Beijing Beijing China 100853

Sponsors and Collaborators

  • Chinese PLA General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Han weidong, Principal Investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT04082910
Other Study ID Numbers:
  • CHN-PLAGH-BT-044
First Posted:
Sep 10, 2019
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Han weidong, Principal Investigator, Chinese PLA General Hospital
Metoprolol
cytokine release syndrome
chimeric antigen receptor T cells
Additional relevant MeSH terms:
Hematologic Neoplasms
Cytokine Release Syndrome
Etanercept
Infliximab
Metoprolol

Study Results

No Results Posted as of Apr 13, 2022