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Table 3 List of published TCR-T cell clinical trials

From: The screening, identification, design and clinical application of tumor-specific neoantigens for TCR-T cells

Target antigen

Epitope

HLA type

Cancer type

Number of patients

Number of TCR-T cells

Phase

NCT number

ORR (%)

Clinical response

Toxicities

Author

HPV16-E6

TIHDIILECV

HLA-A*02:01

HPV16-positive epithelial cancer

12

0.1–13.4 × 1010

I/II

NCT02280811

2 (17%)

2 PR

None

Doran

HPV16-E7

YMLDLQPET

HLA-A*02:01

HPV16-positive epithelial cancer

12

0.1–12.1 × 1010

I

NCT02858310

6 (50%)

6 PR

None

Nagarsheth

MCPyV

KLLEIAPNC

HLA-A*02:01

Merkel cell carcinoma

2

1–9 × 108

I

NCT03747484

1 (20%)

0

None

Veatch

HBV

N.A

HLA-A*02/ HLA-Cw*0801

HBV-HCC

8

1 × 104/kg-5 × 106/kg

I

NCT03899415

1 (12.5%)

1 PR

Liver toxicity; 1 (12.5%)

Meng

NY-ESO-1

SLLMWITQC

HLA-A*02:01

Melanoma (11); Synovial sarcoma (6)

17 (11 + 6)

0.16–13 × 1010

I

NCT00670748

5 (45%); 4 (67%)

2 CR; 7 PR

None

Robbins

NY-ESO-1

SLLMWITQC

HLA-A*02:01

Melanoma (20); Synovial sarcoma (18)

38 (20 + 18)

0.9–13 × 1010

II

NCT00670748

11 (55%); 11 (61%)

5 CR; 17 PR

None

Robbins

NY-ESO-1

SLLMWITQC

HLA-A*02:01

Melanoma; Synovial sarcoma

10

1 × 109

I

NCT02070406

2 (20%)

2 PR

None

Nowicki

NY-ESO-1

SLLMWITQC

HLA-A*02:01/02:06

Synovial sarcoma

12

0.4–14.4 × 109

I/II

NCT01343043

6 (50%)

1 CR; 5PR

CRS: 5 (42%)

D’Angelo

NY-ESO-1

SLLMWITQC

HLA-A*02:01/02:06

Synovial sarcoma

30

2.67 × 109

I/II

NCT01343043

9 (30%)

9 PR

None

Ramachandran

NY-ESO-1

SLLMWITQC

HLA-A*02:01

Melanoma

3

0.6–7.1 × 109

I

NCT03399448

0

0

None

Stadtmauer

MART-1

EAAGIGILTV

HLA-A*02:01

Melanoma

12

0.05–4.56 × 109

I/IIa

NCT02654821

2 (16.7%)

2 PR

CRS/sepsis: 1 (8%); Dermatitis: 10 (83%); Uveitis: 2 (17%); Hearing loss: 4 (33%)

Rohaan

MART-1

EAAGIGILTV

HLA-A*02:01

Melanoma

13

0.6–4.8 × 109

II

NCT00910650

0

0

Skin rash: 3 (23%); CRS: 2 (15%

Chodon

MART-1

AAGIGILTV

HLA-A*02:01

Melanoma

20

0.15–10 × 1010

II

NCT00509288

6 (30%)

6 PR

Skin rash: 14 (70%); Uveitis: 11 (50%); Hearing loss: 10 (50%)

Johnson

MAGE-A3

KVAELVHFL

HLA-A*02:01

Melanoma (7); Synovial sarcoma (1); Esophageal cancer (1)

9 (7 + 1 + 1)

2.8–7.9 × 1010

I/II

NCT01273181

5 (56%)

1 CR; 4 PR

Severe neurologic toxicity: 3 (33%) including 2 deaths

Morgan

MAGE-A3

EVDPIGHLY

HLA-A*01

Melanoma (1); Myeloma (1)

2 (1 + 1)

2.4–5.3 × 109

I

NCT01350401; NCT01352286

0

0

Severe cardiac toxicity and death: 2 (100%)

Linette

MAGE-A3

 

HLA-DPB1*0401

Metastatic solid tumors

17

0.01–123 × 109

I

NCT02111850

4 (23.5%)

1 CR; 3 PR

Liver toxicity: 2 (12%)

Lu

MAGE-A4

NYKRCFPVI

HLA-A*24:02

Esophageal cancer

10

0.2–5 × 109

I

UMIN000002395

0

0

None

Kageyama

MAGE-A4

GVYDGREHTV

HLA-A*02

Advanced solid tumors

38

0.12–10 × 109

I

NCT03132922

9 (23.7%)

9 PR

CRS: 19 (50%)

Hong

MAGE-A10

GLYDGMEHL

HLA-A*02:01/02:06

NSCLC

11

0.1–6.77 × 109

I

NCT02592577

1 (9%)

1 PR

Neurotoxicity: 1 (9%); CRS: 3 (27%)

Blumenschein

gp100

KTWGQYWQV

HLA-A*02:01

Melanoma

16

0.18–11 × 1010

II

NCT00509496

3 (16%)

1 CR; 2 PR

Skin rash: 15 (94%); Uveitis: 4 (25%); Hearing loss: 5 (31%)

Johnson

CEA

IMIGVLVGV

HLA-A*02:01

Colorectal cancer

3

2–4 × 108

I

NCT00923806

1 (33%)

1 PR

Severe transient colitis: 3 (100%)

Parkhurst

TP53

HMTEVVRHC

HLA-A*02:01

Metastatic breast cancer

1

5.3 × 1010

I

NCT03412877

1 (100%)

1 PR

CRS

Kim

KRAS G12D

GADGVGKSA/GADGVGKSAL

HLA-C*08:02

Metastatic pancreatic cancer

1

1.6 × 1010

I

IND27501

1 (100%)

1 PR

None

Leidner

Mutation-associated neoantigens

CRISPR-Cas9 KO-KI

Multiple HLA class I

Metastatic solid tumors

16

0.13–4.0 × 1010

I

NCT03970382

0

0

CRS: 1 (6%); Neurotoxicity: 1 (6%)

Foy

WT1

CMTWNQMNL

HLA-A*24:02

AML; MDS

9

0.12–3.5 × 109

I

UMIN000011519

5 (55.6%)

5 PR

None

Isao Tawara