5.
Example Trial: TGF- β resistant CTLs in HD and NHL Dose levels and target toxicity Target toxicity rate: 0.20 Dose Group Dose Increase of Dosage (Modified Fibonacci) Prior Probability of Toxicity 1 Day 0 2 x 10 7 cells/m 2 D (2) 0.05 Day 14 2 x 10 7 cells/m 2 2 Day 0 6 x 10 7 cells/m 2 3xD (3.3) 0.08 Day 14 6 x 10 7 cells/m 2 3 Day 0 1.5 x 10 8 cells/m 2 7.5xD (5.0) 0.25 Day 14 1.5 x 10 8 cells/m 2
6.
Example CRM Simulations for Trial Average Number of Toxicity 1 1.5 2 2.5 3 Scenario 1 (0.05,0.08,0.25) Scenario 2 (0.05,0.08,0.21) Scenario 3 (0.05,0.15,0.30) Numbers 3+3 Exponential Logistic
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