Table 6. Immune profiling . . P1 . P2 .... | American Society of Hematology

Table 6.

Immune profiling

		P1	P2	P3	P4	P5	P6
Naïve B cells, %∗ Normal range, 58%-86.7%	DFT baseline	30.70	26.80	38.50	11.00	30.30	53.60
Naïve B cells, %∗ Normal range, 58%-86.7%	Latest time point	↑, 90.20	↑, 81.70	↑, 50.80	↑, 75.00	↑, 84.50	↑, 81.40
Switched memory B cells, %∗ Normal range, 3.3%-18.9%	DFT baseline	45.60	46.60	45.10	31.60	60.50	32.00
Switched memory B cells, %∗ Normal range, 3.3%-18.9%	Latest time point	↓, 4.20	↓, 3.80	↓, 34.90	↓, 5.80	↓, 18.10	↓, 28.40
Nonswitched memory B cells, %∗ Normal range, 4.6%-21.4%	DFT baseline	4.90	38.60	1.10	58.70	17.80	0.40
Nonswitched memory B cells, %∗ Normal range, 4.6%-21.4%	Latest time point	↑, 7.30	↑ 47.80	↑, 3.00	↓, 44.80	↑, 18.20	↑, 0.60
Transitional B cells, % Normal range, 1.5%-19.1%	DFT baseline	60.50	19.20	46.60	27.00	44.10	31.60
Transitional B cells, % Normal range, 1.5%-19.1%	Latest time point	↓, 0.98	↓, 6.45	↓, 2.53	↓, 0.00	↓, 3.30	↓, 11.25
Senescent CD4⁺ T cells, % Normal range, 0.18%-5.99%	DFT baseline	21.10	13.80	15.50	34.00	7.30	0.90
Senescent CD4⁺ T cells, % Normal range, 0.18%-5.99%	Latest time point	↓, 5.08	↓, 5.10	↓, 15.09	↓, 5.39	↓, 0.60	↓, 0.10
Senescent CD8⁺ T cells, % Normal range, 1.83%-33.4%	DFT baseline	33.20	21.60	24.60	43.00	19.70	14.60
Senescent CD8⁺ T cells, % Normal range, 1.83%-33.4%	Latest time point	↓, 24.44	↑, 24.10	↑, 35.77	↓, 31.46	↓, 4.80	↓, 3.10
CD4⁺ T cells, % Normal range, 29.3%-52.9%	DFT baseline	34.00	49.40	33.10	43.30	42.10	28.60
CD4⁺ T cells, % Normal range, 29.3%-52.9%	Latest time point	↑, 39.90	↓, 47.38	↑, 47.85	↑, 59.27	↓, 39.0	↑, 46.40
CD8⁺ T cells, % Normal range, 13.5%-23.5%	DFT baseline	65.30	49.50	66.40	55.60	56.30	70.80
CD8⁺ T cells, % Normal range, 13.5%-23.5%	Latest time point	↓, 51.56	↑, 50.50	↓, 48.54	↓, 34.03	↓, 31.00	↓, 54.7
Naïve CD4⁺ T cells, % Normal range, 49.3%-72%	DFT Baseline	11.70	19.20	6.90	6.40	4.90	12.90
Naïve CD4⁺ T cells, % Normal range, 49.3%-72%	Latest time point	↑, 28.49	↑, 28.02	↑, 22.64	↑, 18.06	↑, 8.60	↑, 15.20
Naïve CD8⁺ T cells, % Normal range, 48.6%-87.5%	DFT baseline	18.90	37.10	15.40	23.60	23.00	17.00
Naïve CD8⁺ T cells, % Normal range, 48.6%-87.5%	Latest time point	↑, 29.90	↓, 26.30	↑, 32.90	↑, 25.82	↓, 21.40	↑, 41.30
CD4⁺ T_EM cells, % Normal range, 2.1%-7.4%	DFT baseline	24.50	21.50	31.30	27.40	27.00	25.40
CD4⁺ T_EM cells, % Normal range, 2.1%-7.4%	Latest time point	↓, 18.69	↑, 24.19	↓, 28.16	↓, 25.34	↑, 28.60	↓, 8.90
CD8⁺ T_EM cells, % Normal range, 0.2%-6.9%	DFT baseline	41.30	22.40	27.50	36.60	25.90	29.40
CD8⁺ T_EM cells, % Normal range, 0.2%-6.9%	Latest time point	↓, 29.49	↑, 31.47	↓, 25.32	↑, 39.91	↑, 33.30	↓, 14.90
CD4⁺ T_EMRA cells, % Normal range, 0.1%-8.5%	DFT baseline	0.10	0.10	0.10	0.00	27.00	0.10
CD4⁺ T_EMRA cells, % Normal range, 0.1%-8.5%	Latest time point	↓, 0.00	↑, 1.27	↑, 0.58	↑, 0.27	↓, 0.10	↓, 0.00
CD8⁺ T_EMRA cells, % Normal rang, 0.8%-14%	DFT Baseline	8.00	13.20	3.10	7.80	25.90	22.90
CD8⁺ T_EMRA cells, % Normal rang, 0.8%-14%	Latest time point	↓, 5.06	↑, 33.47	↑, 7.44	↑, 13.62	↓, 13.70	↓, 11.50
CD4⁺ T_CM cells, % Normal range, 24.3%-44.4%	DFT baseline	64.30	59.30	61.80	66.20	68.10	61.70
CD4⁺ T_CM cells, % Normal range, 24.3%-44.4%	Latest time point	↓, 52.63	↓, 36.52	↓, 48.77	↓, 56.06	↓, 62.80	↑, 75.90
CD8⁺ T_CM cells, % Normal range, 9.8%-37.6%	DFT baseline	31.90	27.40	54.10	32.10	39.80	30.80
CD8⁺ T_CM cells, % Normal range, 9.8%-37.6%	Latest time point	↑, 35.53	↓, 8.56	↓, 34.33	↓, 13.62	↓, 31.80	↑, 43.80
IgM, mg/dL Normal range, 20-230 mg/dL	DFT baseline	220	335	282	752	686	190
IgM, mg/dL Normal range, 20-230 mg/dL	Latest time point	↓, 18	↓, 66	↓,68	↓, 264	↓, 166	↓, 91
IgA, mg/dL Normal range, 87-386 mg/dL	DFT baseline	125	81	137	50	253	149
IgA, mg/dL Normal range, 87-386 mg/dL	Latest time point	↑, 157	81	↑, 188	↑, 102	↑, 346	↑, 153
IgE, μg/L Normal range, 6-495 μg/L	DFT baseline	7	8	7	7	194	6063
IgE, μg/L Normal range, 6-495 μg/L	Latest time point	↑, 25	↑, 25	↑, 25	↓, 1	↑, 221	↓, 630
IgG, mg/dL Normal range, 586-1613 mg/dL	DFT baseline	1444 (IRT)	2036 (IRT)	1644 (IRT)	711	773 (IRT)	1670 (IRT)
IgG, mg/dL Normal range, 586-1613 mg/dL	Latest time point	↓, 599	↓, 1631 (IRT)	↓, 1412 (IRT)	↓, 603	↑, 782 (IRT)	↓, 890
IgG1, mg/dL Normal range, 248-846 mg/dL	DFT baseline	910	1150	1130	510	620	1250
IgG1, mg/dL Normal range, 248-846 mg/dL	Latest time point	↓, 770	↓, 1030	↑, 1210	↑, 540	↑, 631‡	↓, 574‡
IgG2, mg/dL Normal range, 130-555 mg/dL	DFT baseline	336	710	280	60	340	480
IgG2, mg/dL Normal range, 130-555 mg/dL	Latest time point	↓, 300	↓, 640	↓, 170	↓, 20	↓, 293†	↓, 118†
IgG3, mg/dL‡ Normal range, 15-109 mg/dL	DFT baseline	44	60	100	80	10	90
IgG3, mg/dL‡ Normal range, 15-109 mg/dL	Latest time point	↓, 20	↓, 30	↓, 60	↓, 60	10†	↓, 68†
IgG4, mg/dL‡ Normal range, 2-104 mg/dL	DFT baseline	67	50	10	10	10	30
IgG4, mg/dL‡ Normal range, 2-104 mg/dL	Latest time point	↓, 10	↓, 40	↓, 0	↓, 0	↑, 24†	↓, 13†

		P1	P2	P3	P4	P5	P6
Naïve B cells, %∗ Normal range, 58%-86.7%	DFT baseline	30.70	26.80	38.50	11.00	30.30	53.60
Naïve B cells, %∗ Normal range, 58%-86.7%	Latest time point	↑, 90.20	↑, 81.70	↑, 50.80	↑, 75.00	↑, 84.50	↑, 81.40
Switched memory B cells, %∗ Normal range, 3.3%-18.9%	DFT baseline	45.60	46.60	45.10	31.60	60.50	32.00
Switched memory B cells, %∗ Normal range, 3.3%-18.9%	Latest time point	↓, 4.20	↓, 3.80	↓, 34.90	↓, 5.80	↓, 18.10	↓, 28.40
Nonswitched memory B cells, %∗ Normal range, 4.6%-21.4%	DFT baseline	4.90	38.60	1.10	58.70	17.80	0.40
Nonswitched memory B cells, %∗ Normal range, 4.6%-21.4%	Latest time point	↑, 7.30	↑ 47.80	↑, 3.00	↓, 44.80	↑, 18.20	↑, 0.60
Transitional B cells, % Normal range, 1.5%-19.1%	DFT baseline	60.50	19.20	46.60	27.00	44.10	31.60
Transitional B cells, % Normal range, 1.5%-19.1%	Latest time point	↓, 0.98	↓, 6.45	↓, 2.53	↓, 0.00	↓, 3.30	↓, 11.25
Senescent CD4⁺ T cells, % Normal range, 0.18%-5.99%	DFT baseline	21.10	13.80	15.50	34.00	7.30	0.90
Senescent CD4⁺ T cells, % Normal range, 0.18%-5.99%	Latest time point	↓, 5.08	↓, 5.10	↓, 15.09	↓, 5.39	↓, 0.60	↓, 0.10
Senescent CD8⁺ T cells, % Normal range, 1.83%-33.4%	DFT baseline	33.20	21.60	24.60	43.00	19.70	14.60
Senescent CD8⁺ T cells, % Normal range, 1.83%-33.4%	Latest time point	↓, 24.44	↑, 24.10	↑, 35.77	↓, 31.46	↓, 4.80	↓, 3.10
CD4⁺ T cells, % Normal range, 29.3%-52.9%	DFT baseline	34.00	49.40	33.10	43.30	42.10	28.60
CD4⁺ T cells, % Normal range, 29.3%-52.9%	Latest time point	↑, 39.90	↓, 47.38	↑, 47.85	↑, 59.27	↓, 39.0	↑, 46.40
CD8⁺ T cells, % Normal range, 13.5%-23.5%	DFT baseline	65.30	49.50	66.40	55.60	56.30	70.80
CD8⁺ T cells, % Normal range, 13.5%-23.5%	Latest time point	↓, 51.56	↑, 50.50	↓, 48.54	↓, 34.03	↓, 31.00	↓, 54.7
Naïve CD4⁺ T cells, % Normal range, 49.3%-72%	DFT Baseline	11.70	19.20	6.90	6.40	4.90	12.90
Naïve CD4⁺ T cells, % Normal range, 49.3%-72%	Latest time point	↑, 28.49	↑, 28.02	↑, 22.64	↑, 18.06	↑, 8.60	↑, 15.20
Naïve CD8⁺ T cells, % Normal range, 48.6%-87.5%	DFT baseline	18.90	37.10	15.40	23.60	23.00	17.00
Naïve CD8⁺ T cells, % Normal range, 48.6%-87.5%	Latest time point	↑, 29.90	↓, 26.30	↑, 32.90	↑, 25.82	↓, 21.40	↑, 41.30
CD4⁺ T_EM cells, % Normal range, 2.1%-7.4%	DFT baseline	24.50	21.50	31.30	27.40	27.00	25.40
CD4⁺ T_EM cells, % Normal range, 2.1%-7.4%	Latest time point	↓, 18.69	↑, 24.19	↓, 28.16	↓, 25.34	↑, 28.60	↓, 8.90
CD8⁺ T_EM cells, % Normal range, 0.2%-6.9%	DFT baseline	41.30	22.40	27.50	36.60	25.90	29.40
CD8⁺ T_EM cells, % Normal range, 0.2%-6.9%	Latest time point	↓, 29.49	↑, 31.47	↓, 25.32	↑, 39.91	↑, 33.30	↓, 14.90
CD4⁺ T_EMRA cells, % Normal range, 0.1%-8.5%	DFT baseline	0.10	0.10	0.10	0.00	27.00	0.10
CD4⁺ T_EMRA cells, % Normal range, 0.1%-8.5%	Latest time point	↓, 0.00	↑, 1.27	↑, 0.58	↑, 0.27	↓, 0.10	↓, 0.00
CD8⁺ T_EMRA cells, % Normal rang, 0.8%-14%	DFT Baseline	8.00	13.20	3.10	7.80	25.90	22.90
CD8⁺ T_EMRA cells, % Normal rang, 0.8%-14%	Latest time point	↓, 5.06	↑, 33.47	↑, 7.44	↑, 13.62	↓, 13.70	↓, 11.50
CD4⁺ T_CM cells, % Normal range, 24.3%-44.4%	DFT baseline	64.30	59.30	61.80	66.20	68.10	61.70
CD4⁺ T_CM cells, % Normal range, 24.3%-44.4%	Latest time point	↓, 52.63	↓, 36.52	↓, 48.77	↓, 56.06	↓, 62.80	↑, 75.90
CD8⁺ T_CM cells, % Normal range, 9.8%-37.6%	DFT baseline	31.90	27.40	54.10	32.10	39.80	30.80
CD8⁺ T_CM cells, % Normal range, 9.8%-37.6%	Latest time point	↑, 35.53	↓, 8.56	↓, 34.33	↓, 13.62	↓, 31.80	↑, 43.80
IgM, mg/dL Normal range, 20-230 mg/dL	DFT baseline	220	335	282	752	686	190
IgM, mg/dL Normal range, 20-230 mg/dL	Latest time point	↓, 18	↓, 66	↓,68	↓, 264	↓, 166	↓, 91
IgA, mg/dL Normal range, 87-386 mg/dL	DFT baseline	125	81	137	50	253	149
IgA, mg/dL Normal range, 87-386 mg/dL	Latest time point	↑, 157	81	↑, 188	↑, 102	↑, 346	↑, 153
IgE, μg/L Normal range, 6-495 μg/L	DFT baseline	7	8	7	7	194	6063
IgE, μg/L Normal range, 6-495 μg/L	Latest time point	↑, 25	↑, 25	↑, 25	↓, 1	↑, 221	↓, 630
IgG, mg/dL Normal range, 586-1613 mg/dL	DFT baseline	1444 (IRT)	2036 (IRT)	1644 (IRT)	711	773 (IRT)	1670 (IRT)
IgG, mg/dL Normal range, 586-1613 mg/dL	Latest time point	↓, 599	↓, 1631 (IRT)	↓, 1412 (IRT)	↓, 603	↑, 782 (IRT)	↓, 890
IgG1, mg/dL Normal range, 248-846 mg/dL	DFT baseline	910	1150	1130	510	620	1250
IgG1, mg/dL Normal range, 248-846 mg/dL	Latest time point	↓, 770	↓, 1030	↑, 1210	↑, 540	↑, 631‡	↓, 574‡
IgG2, mg/dL Normal range, 130-555 mg/dL	DFT baseline	336	710	280	60	340	480
IgG2, mg/dL Normal range, 130-555 mg/dL	Latest time point	↓, 300	↓, 640	↓, 170	↓, 20	↓, 293†	↓, 118†
IgG3, mg/dL‡ Normal range, 15-109 mg/dL	DFT baseline	44	60	100	80	10	90
IgG3, mg/dL‡ Normal range, 15-109 mg/dL	Latest time point	↓, 20	↓, 30	↓, 60	↓, 60	10†	↓, 68†
IgG4, mg/dL‡ Normal range, 2-104 mg/dL	DFT baseline	67	50	10	10	10	30
IgG4, mg/dL‡ Normal range, 2-104 mg/dL	Latest time point	↓, 10	↓, 40	↓, 0	↓, 0	↑, 24†	↓, 13†

Values for DFT baseline were collected from the DFT B- and T-cell immunophenotyping files. Values for latest time point were captured from both the OLE B- and T-cell immunophenotyping files and by trial investigators. Values outside the normal range are italicized. Normal laboratory values are from the literature.^29-34^,^37-40

↓, below normal limits; ↑, above normal limits; T_CM, central memory T cells; T_EMRA, terminally differentiated effector memory CD4⁺ and CD8⁺ T cells.

∗

Denotes immune subsets that were only collected up to year 1 of the extension study.

†

Data were collected past year 1.

‡

For values that were reported <[value], the actual value was entered.

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