Table 1 Patient characteristics Dose... | American Society of Hematology

Table 1

Patient characteristics

Dose level	Patient no.	Age, y	Diagnosis	Regimen	Donor	Day of CYT107 initiation after HSCT	Baseline T-cell counts, /mm³*
Dose level	Patient no.	Age, y	Diagnosis	Regimen	Donor	Day of CYT107 initiation after HSCT	CD3	CD4	CD8
10 μg/kg	14-101	67	AML	Bu/Mel/Flu	MRD	96	526	219	299
	14-102	55	AML	TBI/Thio/Flu	MUD	110	133	102	32
	14-103	59	AML	Bu/Mel/Flu	MUD	76	403	272	118
20 μg/kg	14-201	27	AML	Bu/Mel/Flu	MRD	244‡	233	124	101
	14-203†	67	AML	Bu/Mel/Flu	MMUD	222	35	30	17
	14-204	54	AML	TBI/Thio/Cy	MRD	73	69	20	55
	14-205	43	AML	TBI/Thio/Cy	MUD	208	89	69	24
	14-206	61	MDS	Bu/Mel/Flu	MRD	69	32	21	10
	14-207	63	MDS	Bu/Mel/Flu	MRD	61	13	5	9
30 μg/kg	14-301	39	CML	TBI/Thio/Cy	MUD	60	121	46	75
	14-302	62	AML	Bu/Mel/Flu	MRD	109	262	262	10
	14-303	65	AML	Bu/Mel/Flu	MRD	110	0	0	0

Dose level	Patient no.	Age, y	Diagnosis	Regimen	Donor	Day of CYT107 initiation after HSCT	Baseline T-cell counts, /mm³*
Dose level	Patient no.	Age, y	Diagnosis	Regimen	Donor	Day of CYT107 initiation after HSCT	CD3	CD4	CD8
10 μg/kg	14-101	67	AML	Bu/Mel/Flu	MRD	96	526	219	299
	14-102	55	AML	TBI/Thio/Flu	MUD	110	133	102	32
	14-103	59	AML	Bu/Mel/Flu	MUD	76	403	272	118
20 μg/kg	14-201	27	AML	Bu/Mel/Flu	MRD	244‡	233	124	101
	14-203†	67	AML	Bu/Mel/Flu	MMUD	222	35	30	17
	14-204	54	AML	TBI/Thio/Cy	MRD	73	69	20	55
	14-205	43	AML	TBI/Thio/Cy	MUD	208	89	69	24
	14-206	61	MDS	Bu/Mel/Flu	MRD	69	32	21	10
	14-207	63	MDS	Bu/Mel/Flu	MRD	61	13	5	9
30 μg/kg	14-301	39	CML	TBI/Thio/Cy	MUD	60	121	46	75
	14-302	62	AML	Bu/Mel/Flu	MRD	109	262	262	10
	14-303	65	AML	Bu/Mel/Flu	MRD	110	0	0	0

AML indicates acute myelogenous leukemia; MDS, myelodysplastic syndrome; CML, chronic myelogenous leukemia; Bu, busulfan; Mel, melphalan; Flu, fludarabine; TBI, total body irradiation; Thio, thiotepa; Cy, cyclophosphamide; MRD, matched related donor; MUD, matched unrelated donor; and MMUD, mismatched unrelated donor.

Baseline T-cell counts represent the mean of 2 consecutive tests before treatment, including 1 test performed immediately before the initial injection.

†

Patient 14-203 was removed from study after the first injection.

‡

Patient 14-201 was treated with an approved protocol deviation starting at day 244 after HSCT because of poor immune recovery determined at 6 months after HSCT.

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