Table 3.

Follow-Up Testing for RCLs in Subjects Infused with Gene-Modified T Cell Products

Study No.	Principal Investigator	No. of Products Infused	No. of Subjects Infused	No. of Subjects with RCL Follow-Upa	Method of RCL Detection	Level of Sensitivity per DNA
11-2	C.H.J.	2	2	1	VSV-G DNA PCR	25 copies per 1 μg
11-3	C.H.J.	19	17	16	VSV-G DNA PCR	25 copies per 1 μg
11-4	C.H.J.	2	2	2	VSV-G DNA PCR	25 copies per 1 μg
11-11	C.H.J.	24	24	21	VSV-G DNA PCR	25 copies per 1 μg
11-12	C.H.J.	14	13	13	VSV-G DNA PCR	25 copies per 1 μg
11-13	C.H.J.	1	1	0	VSV-G DNA PCR	25 copies per 1 μg
12-4	C.H.J.	36	36	34	VSV-G DNA PCR	25 copies per 1 μg
12-16	M.J.	3	3	2	VSV-G DNA PCR	10 copies per 50 ng
13-4	C.H.J.	32	32	23	VSV-G DNA PCR	25 copies per 1 μg
13-12	G.B.-S.	31	31	24	VSV-G DNA PCR	5 copies per 100 ng
13-15	S.F.	5	5	5	VSV-G DNA PCR	2.5 copies per 50 ng
14-9	C.H.J.	25	25	14	VSV-G DNA PCR	25 copies per 1 μg
14-10	C.H.J.	34	34	30	VSV-G DNA PCR	25 copies per 1 μg
14-12	C.J.T.	76	76	49	VSV-G DNA PCR	10 copies per 1 μg
14-18	T.F.	14	14	11	VSV-G DNA PCR	10 copies per 200 ng
14-27	S.F.	7	7	6	VSV-G DNA PCR	2.5 copies per 50 ng
15-9	S.F.	6	4	3b	VSV-G DNA PCR	2.5 copies per 50 ng
15-10	S.F.	6	6	5	VSV-G DNA PCR	2.5 copies per 50 ng
15-11	S.F.	11	11	11	VSV-G DNA PCR	2.5 copies per 50 ng
15-26	M.J.	45	23	19	VSV-G DNA PCR	10 copies per 50 ng
15-36	S.F.	2	2	2	VSV-G DNA PCR	2.5 copies per 50 ng
16-1	M.J.	14	7	5	VSV-G DNA PCR	10 copies per 50 ng
Total		409	375	296

VSV-G, vesicular stomatitis virus G protein.

^a≥30 Days post-infusion.

^b2 subjects were tested by PCR, and 1 subject was tested by serology.