Table of Contents 
Revisions 1 
Abstract 2 
Non-Technical Abstract 3 
Schema 4 
1.0 Objectives 5 
2.0 Background 5 
3.0 Patient Eligibility 7 
4.0 Pretreatment Evaluation 8 
5.0 Treatment Plan 8 
6.0 Cell Harvesting, Processing, Transduction, and Reinfusion 12 
7.0 Dose Modifications 15 
8.0 On Study Evaluations 16 
9.0 Statistical Considerations 17 
10.0 Off-Study Criteria 18 
1 1 .0 Reporting of Adverse Drug Reactions 1 8 
12.0 Response Criteria 18 
13.0 References 19 
Points to Consider 
Appendix I Scientific Rationale 
Appendix II Analysis of Clinical Grade Viral Supernatant 
Appendix III Pharmaceutical Information 
Appendix IV Informed Consents 
Appendix V Toxicity Criteria 
Appendix VI Vector Nucleotide Sequence 
Appendix VII Condensed Curriculum Vitae of Investigators 
Appendix VIII Pertinent Publications 
Recombinant DNA Research, Volume 18 
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