Table 1

Baseline characteristics and DLs

Patient no.	Sex	Age (years)	Cancer diagnosis	Prior lines of systemic therapies	ECOG performance status at baseline	LDH level at baseline (xULN)	Number of infused CD3⁺CD8⁺Dex⁺ T cells (×10⁹)	DL
1	Female	63	SCC of Anus	5	1	1.5	0.086	DL1
2	Male	33	SCC of oropharynx	5	1	1.0	0.105	DL1
3	Female	64	Melanoma (mucosal)	4	1	1.1	0.187	EC1
4	Female	53	NSCLC adenocarcinoma	6	1	0.6	0.415	EC1
5	Female	69	SCC of anus	3	1	0.9	0.513	DL2
6	Male	49	Melanoma (unknown primary)	7	1	2.1	0.648	DL2
7	Male	60	Melanoma (unknown primary)	6	0	2.6	1.278	EC2
8	Male	59	Melanoma (cutaneous)	5	1	1.2	1.40	EC2
9	Male	64	Melanoma (cutaneous)	3	1	1.2	1.43	EC2
10	Female	45	Melanoma (cutaneous)	4	1	1.5	1.601	DL3
11	Male	53	Osteosarcoma	2	1	0.6	1.87	DL3
12	Male	55	Melanoma (cutaneous)	5	0	0.9	1.902	DL3
13	Male	72	NSCLC adenocarcinoma	6	1	2.1	2.065	DL3
14	Female	38	Hepatocellular carcinoma	4	0	0.7	2.086	DL3
15	Male	20	Rhabdomyosarcoma	7	1	1.9	2.277	DL3
16	Male	72	Hepatocellular carcinoma	1	0	1.1	2.570	DL3
Median (min, max) or Percentage	62.5% (male) 37.5% (female)	57 (20, 72)		5 (1, 7)	25.0% (0) 75.0% (1)	1.15 (0.6, 2.6)	1.415 (0.086, 2.570)

The table depicts baseline characteristics of all 16 treated patients including median, range (min, max) or percentage where applicable. 14 patients were of Caucasian ethnicity, 1 patient was Hispanic or Latino and 1 patient was black or African American. DL1 is defined as 50×10⁶ transduced cells/m² BSA±20%, DL2 as 300×10⁶ transduced cells/m² BSA±20%, and DL3 as 1000×10⁶ transduced cells/m² BSA±20%. Enrichment cohorts resemble intermediate DLs between DL1 and DL2 as well as DL2 and DL3, respectively.
BSA, body surface area; Dex, dextramer; DL, dose level; EC, enrichment cohort; ECOG, Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase; NSCLC, non-small cell lung cancer; SCC, squamous cell carcinoma; ULN, upper limit of normal.