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. 2023 Aug 28;16:100. doi: 10.1186/s13045-023-01497-3

Table 7.

The clinical trials of tumor vaccine and CAR-T in TNBC

Drug name Com Num Regiments Phase Status Object POM NCT number
Neoantigen vaccine Nab-paclitaxel plus Durvalumab 70

Vaccine and poly-ICLC SC: on days 1, 4, 8, 15, 22, 50, and 78

Nab-paclitaxel: iv on days 1, 8, and 15 of each cycle

Durvalumab: iv on day 1 of each cycle

II Recruiting Advanced or mTNBC PFS NCT03606967
anti-meso CAR-T cells 20 a standard 3 + 3 dose escalation approach I Unknown TNBC AEs NCT02580747
cMet RNA CAR T cells 6 3 × 10^7 or 3 × 10^8 cells I Completed mTNBC AEs NCT01837602
CART-TnMUC1 cells 112 Single iv administration I Active, not recruiting

HER2-

TNBC

DLTs NCT04025216
EGFR/B7H3 CAR-T cells 30 2 × 10^6/kg CAR-T cells I Recruiting TNBC AEs NCT05341492
NKG2DL-targeting CAR-grafted γδ-T Cells 10 "3 + 3" dose escalation study design ranging from 3 × 10^8—3 × 10^9 CAR-γδ-T cells. Each cycle of therapy will consist of 4 iv, given 7 days apart I Unknown TNBC DLTs NCT04107142
ROR1-targeted CAR T cells (LYL797) 54 NA I Recruiting TNBC DLTs, TEAEs NCT05274451
ROR1-CAR-T cell 21 ROR1 CAR-specific autologous T-lymphocytes IV over 20–30 min I Terminated TNBC AEs NCT02706392
PD-1+ TILs 20 5 to 10 mg/mL/min I/II Not yet recruiting PD1TNBC AEs, PFS NCT05451784
TC-510 115 NA I/II Recruiting TNBC DLTs, ORR NCT05451849
BT-001 Pembrolizumab 48

BT-001: administered at different dose

Pembrolizumab: 200 mg iv q3w

I/II Recruiting TNBC AEs NCT04725331

CAR-T: chimeric antigen receptor-T cell; mTNBC: metastatic triple negative breast cancer; HER2-: HER2 negative; mBC: metastatic breast cancer; gBRCA1/2 m: germline BRCA1/2 mutated; ORR: overall response rate; AEs: adverse events; PFS: progression-free survival; DLTs: dose-limiting toxicity; TEAEs: treatment emergent adverse events; ROR1: receptor tyrosine kinase like orphan receptor 1; PD-1: programmed cell death protein 1; EGFR: epidermal growth factor receptor; NKG2DL: natural killer group 2, member D