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

Sponsor
Chinese PLA General Hospital
Study ID
NCT04082910
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Hematological Malignancy
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
16 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Metoprolol — DRUG
    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 — DRUG
    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 Details

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.

Key Dates

Start date
Sep 15, 2019
Status verified
Apr 2022
Primary completion
Dec 30, 2022
Completion
Dec 30, 2023

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

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

Central Contacts

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