Table 1 Detection of a... | American Society of Hematology

Table 1

Detection of a transgene-specific immune response in the treated patients

Patient no., infusion	No. of GMCs infused, 10⁶/kg	Interval HSCT to infusion, wk	CD4⁺ T cells at infusion, cells/μL	Immune response	Interval between GMC infusion and immune response evaluation, wk	Vector	Target antigen	HLA restriction
Patient 2
1st	0.1	41	210	Negative	8	SFCMM2	HSV-TK/neo	Bw60, B7
2nd	0.5	49	93	ND	—	SFCMM2	HSV-TK/neo	Bw60, B7
3rd	0.4	53	234	Positive	8	SFCMM2	HSV-TK/neo	Bw60, B7
Patient 7
1st	0.1	38	229	ND	—	SFCMM2	HSV-TK	B7; Cw7
2nd	1	41	165	ND	—	SFCMM2	HSV-TK	B7; Cw7
3rd	10	73	107	Positive	47	SFCMM2	HSV-TK	B7; Cw7
Patient 8
1st	5	8	ND	IC	10	SFCMM2	HSV-TK	ND
2nd	10	16	47	IC	11	SFCMM2	HSV-TK	ND
3rd	5	24	60	Neg/pos*	43/102*	SFCMM2	HSV-TK	ND
Patient 16
1st	70	12	208	Negative	38	SFCMM3	HSV-TK	A1, B35, Cw4
2nd	70	67	270	Positive	7	SFCMM3	HSV-TK	A1, B35, Cw4
Patient 17
1st	47	52	442	Positive	14	SFCMM3	HSV-TK	B35, B51; Cw4
Patient 20
1st	100	278	656	Positive	23	SFCMM3	HSV-TK	ND
Patient 21
1st	50	120	200	Positive	8	SFCMM3	HSV-TK	ND

Patient no., infusion	No. of GMCs infused, 10⁶/kg	Interval HSCT to infusion, wk	CD4⁺ T cells at infusion, cells/μL	Immune response	Interval between GMC infusion and immune response evaluation, wk	Vector	Target antigen	HLA restriction
Patient 2
1st	0.1	41	210	Negative	8	SFCMM2	HSV-TK/neo	Bw60, B7
2nd	0.5	49	93	ND	—	SFCMM2	HSV-TK/neo	Bw60, B7
3rd	0.4	53	234	Positive	8	SFCMM2	HSV-TK/neo	Bw60, B7
Patient 7
1st	0.1	38	229	ND	—	SFCMM2	HSV-TK	B7; Cw7
2nd	1	41	165	ND	—	SFCMM2	HSV-TK	B7; Cw7
3rd	10	73	107	Positive	47	SFCMM2	HSV-TK	B7; Cw7
Patient 8
1st	5	8	ND	IC	10	SFCMM2	HSV-TK	ND
2nd	10	16	47	IC	11	SFCMM2	HSV-TK	ND
3rd	5	24	60	Neg/pos*	43/102*	SFCMM2	HSV-TK	ND
Patient 16
1st	70	12	208	Negative	38	SFCMM3	HSV-TK	A1, B35, Cw4
2nd	70	67	270	Positive	7	SFCMM3	HSV-TK	A1, B35, Cw4
Patient 17
1st	47	52	442	Positive	14	SFCMM3	HSV-TK	B35, B51; Cw4
Patient 20
1st	100	278	656	Positive	23	SFCMM3	HSV-TK	ND
Patient 21
1st	50	120	200	Positive	8	SFCMM3	HSV-TK	ND

The development of an immune response against the transgene products was monitored by ex vivo stimulation of PBMCs against autologous-transduced and allogeneic T cells. In the presence of an anti-allospecific immune response, the patient was considered not immunized (negative) or immunized (positive) depending on the anti-HSV-TK cytolytic activity detected. In the absence of an anti-allo immune response, the patient was considered immune compromised (IC).

ND indicates not done; —, not applicable.

Forty-three weeks after the 3rd infusion the immune-response was negative, but a positive response was detected after 102 weeks; in the meantime, ganciclovir was administered.

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