A3 adenosine receptor ligand for managing cytokine release syndrome
A technology of adenosine receptors and cells, applied in the field of immunotherapy
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[0224] Example 1: Clinical studies of A3AR agonists: IB-MECA (CF101) and Cl-IB-MECA (CF102)
[0225] The clinical study (the "Study") is a randomized, two-tier, placebo-controlled, parallel-group study of the safety and efficacy of CF101 (a pharmaceutical composition containing IB-MECA as an active ingredient) and CF102. CF101 and CF102 were administered orally to immunotherapy patients with moderate to severe CRS. Patients were randomized to receive oral pills of CF101 or CF102 or a matching placebo.
[0226] Patients participating in the study had to meet a number of eligibility criteria (i.e., must meet criteria for human subjects to participate in the study), including (1) recurrent blood cancer and any recurrence after immunotherapy and (2) normal organ function.
[0227] The clinical outcome of improving CRS symptoms was determined by various relevant parameters, such as the frequency of CRS, especially grade 4 CRS (grading according to the National Cancer Institute Com...
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