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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082910
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Brief Summary:
The aim of this single-center prospective study is to evaluate the efficacy and feasibility of Metoprolol, a beta-blocker, in the treatment of cytokine release syndrome (CRS) caused by Chimeric antigen receptor T (CART) cells, to verify its effects on decreasing the level of Interleukin-6 (IL-6), and to determine whether it can replace the intervention of other antibodies, such as tocilizumab.

Condition or disease Intervention/treatment Phase
Solid Tumor Hematologial Malignancy Drug: Metoprolol Drug: anti-TNFα antibody Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 15, 2019
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Therapeutic group
Patients with predicted experiencing ≤ grade 2 CRS after CAR T cells infusion, will be enrolled therapeutic group (metoprolol monotherapy, 12.5mg per time, bid; from the peak phase to extinction phase of CRS, up to 7 days).
Drug: Metoprolol
Metoprolol for patients undergoing CRS after CAR T cells infusion.

Experimental: Prophylactic group
Patients with predicted experiencing ≥ grade 3 CRS after CAR T cells infusion, will be enrolled prophylactic group (metoprolol plus anti-TNFα antibody. 1) metoprolol, 12.5mg per time, bid; from one day before cells infusion to extinction phase of CRS, up to 14 days. 2) anti-TNFα antibody will be used at the peak period of CRS).
Drug: Metoprolol
Metoprolol for patients undergoing CRS after CAR T cells infusion.

Drug: anti-TNFα antibody
Metoprolol plus anti-TNFα antibody for patients in prophylactic group.




Primary Outcome Measures :
  1. Efficacy of Metoprolol on CRS [ Time Frame: two weeks ]
    Control of CRS, based on the change of temperature


Secondary Outcome Measures :
  1. The change of IL-6 after Metoprolol [ Time Frame: two weeks ]
    Detection of the level of IL-6 in Peripheral blood



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female participant 18 Years to 70 Years Patients with malignant tumors who received the treatment of CART cells. Estimated life expectancy ≥ 12 weeks (according to investigator's judgement) Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Adequate organ function

Exclusion Criteria:

  • Significant bradycardia (heart rate < 45/min) cardiogenic shock severe or acute heart failure poor peripheral circulation perfusion degree II or III atrioventricular block sick sinus syndrome severe peripheral vascular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082910


Contacts
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Contact: Weidong Han, M.D. +861055499341 hanwdrsw@sina.com

Locations
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China, Beijing
Biotherapeutic Department of Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Weidong Han, M.D    +861055499341    hanwdrsw@sina.com   
Contact: Qingming Yang, M.D    +861055499341    yangqm@medmail.com.cn   
Sponsors and Collaborators
Chinese PLA General Hospital
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Responsible Party: Han weidong, Principal Investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT04082910    
Other Study ID Numbers: CHN-PLAGH-BT-044
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Han weidong, Chinese PLA General Hospital:
Metoprolol
cytokine release syndrome
chimeric antigen receptor T cells
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes
Metoprolol
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action