toxic event will be any grade 3 or higher toxicity related to 
administration of the cells. 
The following two stage rule will be used to test the null hypothesis 
that the true toxicity rate is greater than or equal to 30 per cent against 
the alternative that the true toxicity rate is less than or equal to 5 per 
cent. With this design, accrual to the study will stop early if it appears 
that the overall toxicity rate is high. 
In the first stage, 10 eligible patients will be entered. If 3 or more toxic 
events are observed, we will conclude that the data support the null 
hypothesis and the study should be closed to further accrual. If 2 or less 
toxic events are observed in the first 10 patients, an additional 10 
patients will be accrued to this study (for a total of 20). 
Overall, if 4 or more toxic events are observed, we will conclude that 
the data support the null hypothesis that the toxicity rate is greater than 
or equal to 30 per cent. If 3 or less toxic events are observed, we will 
reject the null hypothesis in favor of the alternative hypothesis that 
the toxicity rate is less than or equal to 5 per cent. 
This design has an approximate size alpha = 0.0647 and power 0.9096 to 
test the previously stated hypothesis. 
Frequency of toxicity occurrence will be tabulated by the most severe 
occurrence. Confidence intervals will be provided to aid in estimating 
toxicity and response rates. Response and survival will be estimated by 
the methods of Kaplan and Meier. 
13.0 ETHICAL AND REGULATORY CONSIDERATIONS 
13.1 Informed Consent 
The principles of informed consent described in FDA 
Regulations (21CFR Part 50) must be followed to comply with 
Food and Drug Administration regulations. A patient must give 
written consent to participate in the study which must be 
witnessed and dated, and retained by the investigator as part of 
the study records. A copy of the consent form must be given to 
the patient. A copy of the consent form must be sent to the 
sponsor. 
13.2 Institutional Review 
This study must be approved by an appropriate Institutional 
Review Board (IRB) as defined by the CRF. IRB approval of the 
protocol and the informed consent form for this study must be 
given in writing. 
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