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Table 7 The clinical trials of tumor vaccine and CAR-T in TNBC

From: Recent advances in targeted strategies for triple-negative breast cancer

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

PD1+ TNBC

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

  1. 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