cardiac arrhythmias, and inadvertent infusion of contaminated 
cultures or mislabeled cells. 
Potential risks with the gene insertion portion of the proposal include 
the inadvertent contamination of the retrovirus preparation with 
replication competent murine retrovirus generated by a recombination 
event occurring in the vector virus packaging cell line. During 
retroviral-mediated gene transfer, the cultured T cells could also 
undergo an insertional event causing the malignant transformation of 
the cell. The cultured T cell population could theoretically contain cell 
subpopulations with potential undesirable consequences for the 
patient such as autoreactive ceils. No such effects have been 
encountered to date in any of the clinical studies utilizing gene- 
modified cells. 
Toxicities and adverse drug events (ADRs) related to the 
administration of genetically marked lymphocytes will be reported 
promptly to the NIAID-Clinical Research Subpanel, (301) 402-2126. 
Notification of the NIAID-CRS is required even if there is only a 
suspicion of a drug effect. Previously unknown grade 1, 2, and 3 
reactions will be reported to the NIAID-CRS in writing within 10 
working days. Grade 4 (life-threatening) reactions and patient deaths 
while on treatment will be reported to the NIAID-CRS by phone within 
24 hours. A written report will follow within 10 working days. 
Written reports will be sent to: 
NIAID-Clinical Research Subpanel 
Solar Bldg, Room 3A01 
6101 Executive Blvd. 
Rockville, Maryland 20852 
and to : 
Center for Biologies Evaluation and Research 
Food and Drug Administration 
Building 29A 
8800 Rockville Pike 
Bethesda, Maryland 20892 
Recombinant DNA Research, Volume 16 
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