Solid TumorPhase 1/2NCT04082910
Metoprolol Treatment for Cytokine Release Syndrome in Patients Treated With Chimeric Antigen Receptor T Cells
A Phase 1/2 study testing Metoprolol and metoprolol, infliximab, etanercept, tocilizumab and/or other agents in people with Solid Tumor and Hematological Malignancy, run by Chinese PLA General Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Solid Tumor, Hematological Malignancy
- What is being tested?
- Metoprolol and metoprolol, infliximab, etanercept, tocilizumab and/or other agents
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2019to 30 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with lymphoma, leukemia or other malignant diseases who were enrolled for CAR T cell therapy.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Weidong Han, M.D, +861066939711, hanwdrsw@sina.com
Qingming Yang, M.D, +861066939460, yangqm@medmail.com.cn
About this study
Official title: Metoprolol for the Treatment of Cytokine Release Syndrome in Patients Treated With Chimeric Antigen Receptor T Cells
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.
- Conditions
- Solid Tumor, Hematological Malignancy
- Being tested
- Metoprolol, metoprolol, infliximab, etanercept, tocilizumab and/or other agents
- Keywords
- Metoprolol, cytokine release syndrome, chimeric antigen receptor T cells
- Medical subject headings
- Hematologic Neoplasms, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoprololDrug
Metoprolol was given in patients who received CAR T cell therapy for CRS control or CRS precaution.
metoprolol, infliximab, etanercept, tocilizumab and/or other agentsDrug
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 group | Role | What they receive |
|---|---|---|
| Conditional therapy mode group | Experimental | 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. Receives: Drug: Metoprolol; Drug: metoprolol, infliximab, etanercept, tocilizumab and/or other agents |
| Prophylactic therapy mode group | Experimental | 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. Receives: Drug: Metoprolol; Drug: metoprolol, infliximab, etanercept, tocilizumab and/or other agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of metoprolol in patients treated by CAR T infusions.
Reduction of heart rate in bpm (beats per minute)
Measured: 2-4 weeks
Safety and tolerability of metoprolol in patients treated by CAR T infusions.
Reduction of blood pressure in mmHg
Measured: 2-4 weeks
Secondary outcomes (2)
Efficacy of metoprolol for CRS control
Reduction of Body temperature in degree centigrade
Measured: 2-4 weeks
Efficacy of metoprolol for CRS precaution
Reduction of serum IL-6 in pg/dl.
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start15 Sep 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082910
- Sponsor's protocol ID
- CHN-PLAGH-BT-044
- Status last verified
- Apr 2022
- First submitted
- 4 Sep 2019
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metoprolol for the Treatment of Cytokine Release Syndrome in Patients Treated With Chimeric Antigen Receptor T Cells
- ClinicalTrials.gov ID
- NCT04082910
- Acronym / sponsor ID
- CHN-PLAGH-BT-044
- Conditions
- Solid Tumor, Hematological Malignancy
- Keywords
- Metoprolol, cytokine release syndrome, chimeric antigen receptor T cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conditional therapy mode group | Experimental | Drug: Metoprolol, Drug: metoprolol, infliximab, etanercept, tocilizumab and/or other agentsMetoprolol (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. |
| Prophylactic therapy mode group | Experimental | Drug: Metoprolol, Drug: metoprolol, infliximab, etanercept, tocilizumab and/or other agentsMetoprolol (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. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with lymphoma, leukemia or other malignant diseases who were enrolled for CAR T cell therapy.
Key exclusion criteria (8 listed)
- Significant bradycardia (heart rate < 45/min)
- Cardiogenic shock
- Severe or acute heart failure
- Poor peripheral circulation perfusion
- Grade II or III atrioventricular block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetoprololMetoprolol was given in patients who received CAR T cell therapy for CRS control or CRS precaution. | Drug | Conditional therapy mode group, Prophylactic therapy mode group |
| metoprolol, infliximab, etanercept, tocilizumab and/or other agentsDuring 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. | Drug | Conditional therapy mode group, Prophylactic therapy mode group |
Primary outcome
Safety and tolerability of metoprolol in patients treated by CAR T infusions.
Time frame: 2-4 weeks
Reduction of heart rate in bpm (beats per minute)
Safety and tolerability of metoprolol in patients treated by CAR T infusions.
Time frame: 2-4 weeks
Reduction of blood pressure in mmHg
2 secondary outcomes
Efficacy of metoprolol for CRS control
Time frame: 2-4 weeks
Efficacy of metoprolol for CRS precaution
Time frame: 2-4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Metoprolol and metoprolol, infliximab, etanercept, tocilizumab and/or other agents in people with Solid Tumor and Hematological Malignancy, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weidong Han, M.D. (+861066939711, hanwdrsw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of metoprolol in patients treated by CAR T infusions. (time frame: 2-4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.