RECOMBINANT DNA ADVISORY COMMITTEE 
HUMAN GENE THERAPY SUBCOMMITTEE 
Summary of Activities Following 
Meeting July 29, 1988 
and 
Telephone Conference September 29, 1988 
The sense of the subcommittee and outside consultants is supportive of the 
general concept of the use of recombinant vectors in gene transfer 
procedures for marking somatic cells in humans as an aid to the development 
of important new advances in clinical research. Because such procedures 
are not done primarily to benefit the subjects, and may in fact, be of no 
benefit to the individuals involved, proposals to carry out these 
experiments must be supported by a clear database demonstrating that the 
specific procedures planned are safe and likely to yield knowledge of 
value; in the present case, knowledge likely to enhance further development 
of cancer immunotherapy with autologous human tumor infiltrating 
lymphocytes (TIL) . Because the present proposal would be the first to 
involve human subjects, and clearly sets precedents for proposals to 
follow, the subcommittee views the evaluation of the supporting database as 
especially important. 
At its meeting on July 29, 1988, the subcommittee agreed that the 
supporting database for the proposal submitted by Drs . Anderson, Blaese, 
and Rosenberg was insufficient and recommended deferral of consideration of 
the proposal until this information was available. As an aid to the 
applicants, the subcommittee listed three points this database should 
address with respect to animal testing and two additional issues to be 
addressed with respect to human TIL into which a vector has been 
introduced. The subcommittee felt that provision of the requested data was 
well within the range of present technology and could be provided without 
unreasonably delaying the proposed clinical research. 
A telephone conference was held on September 29, 1988 by the subcommittee 
to review additional data submitted by the applicants to determine whether 
or not there was now a database sufficient to act on the proposal. Our 
unanimous conclusion was that, although some progress had been made, we 
were not yet in possession of the requested information. Our 
recommendation of July 29, therefore, stands unchanged. 
As an aid to the applicants and members of the Recombinant DNA Advisory 
Committee, the minutes of the telephone conference are appended to this 
summary statement which include evaluation of the specific data submitted 
by the applicants with respect to the points at issue raised by the 
subcommittee . 
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Recombinant DNA Research, Volume 13 
