CAR-T Cell Immunotherapy for HCC Targeting GPC3.

在肝癌中靶向GPC3的CAR-T細胞免疫治療

ClinicalTrials.gov Identifier 

注冊編號

NCT02723942

Sponsor

發(fā)起人/單位

Fuda Cancer Hospital, Guangzhou

廣州復(fù)大腫瘤醫(yī)院

Study Chair

研究主導(dǎo)者

Lizhi Niu, PhD

牛立志

Brief Summary

簡要描述

The purpose of this study is to preliminarily evaluate the safety and efficacy of CAR-T cell immunotherapy for GPC3 positive hepatocellular carcinoma.

本次研究的目的是初步評價CAR-T細胞免疫治療在GPC3陽性的肝細胞癌中的安全性和有效性。

Recruiting objects

招募對象

18-70 years（GPC3 Positive Hepatocellular Carcinoma）

18-70歲的GPC3陽性的肝細胞癌患者

Study Phase

研究階段

Phase 1&Phase 2

臨床1期和2期

CAR-T Cell Immunotherapy for EphA2 Positive Malignant Glioma Patients.

在惡性神經(jīng)膠質(zhì)瘤患者中靶向EphA2陽性的CAR-T細胞免疫治療

ClinicalTrials.gov Identifier 

注冊編號

NCT02575261

Sponsor

發(fā)起人/單位

Fuda Cancer Hospital, Guangzhou

廣州復(fù)大腫瘤醫(yī)院

Study Chair

研究主導(dǎo)者

Lizhi Niu, PhD

牛立志

Brief Summary

簡要描述

The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in treating with EphA2 positive malignant glioma patients.

本次研究的目的是初步評價CAR-T細胞免疫治療在EphA2陽性的惡性神經(jīng)膠質(zhì)瘤患者中的安全性和有效性。

Recruiting objects

招募對象

18-80 years（EphA2 Positive Malignant Glioma）

18-80歲的EphA2陽性的惡性神經(jīng)膠質(zhì)瘤患者

Study Phase

研究階段

Phase 1&Phase 2

臨床1期和2期

EGFRvIII CAR T Cells for Newly-Diagnosed GBM.

在最新確診的膠質(zhì)母細胞瘤患者中靶向 EGFRvIII 陽性的CAR-T細胞免疫治療

ClinicalTrials.gov Identifier 

注冊編號

NCT02664363

Sponsor

發(fā)起人/單位

Duke University Medical Center （Gary Archer Ph.D.）

杜克大學(xué)醫(yī)學(xué)中心（Gary Archer博士）

Study Chair

研究主導(dǎo)者

Gordana Vlahovic,

M.D.

Brief Summary

簡要描述

Newly diagnosed glioblastoma subjects who are eligible will be enrolled following surgery to remove the brain tumor. They will then undergo a leukapheresis to harvest cells for the generation of the study drug, Epidermal Growth Factor variant III Chimeric Antigen Receptor (EGFRvIII CAR) T cells prior to beginning standard of care (SOC) radiation therapy (RT) with temozolomide (TMZ). Once SOC RT with TMZ is completed, subjects will return for the post-RT brain imaging assessment, and if stable will start post-RT TMZ cycles. During the 3rd cycle of post-RT TMZ, the EGFRvIII CAR T cells will be infused in dose escalation cohorts. Following a one month delay between cycles, the subject will resume post-RT cycles of TMZ and be monitored with blood work and brain imaging as per SOC. Once the maximally tolerated dose (MTD) is reached in the dose escalation cohorts, an expanded cohort of 12 subjects will be enrolled to obtain a more precise estimate of the probability of unacceptable toxicity and to track the EGFRvIII CAR T cells using 111 Indium (111In) labeling. Computed Tomography (CT) will be done on days 1, 5, and 10 post-infusion to determine intracerebral (IC) localization.

新診斷膠質(zhì)母細胞瘤患者手術(shù)切除腦內(nèi)腫瘤組織后，在3次RT+TMZ標(biāo)準(zhǔn)治療（SOC）后進行EGFRvIII-CAR T 注射。注射第1,5,10天后最后通過CT掃描觀察細胞在顱內(nèi)的定位。

Recruiting objects

招募對象

18-80 years（Glioblastoma）

18-80歲的膠質(zhì)母細胞瘤患者

Study Phase

研究階段

Phase 1

臨床1期

CAR-T Hepatic Artery Infusions and Sir-Spheres for Liver Metastases.

腫瘤肝轉(zhuǎn)移患者用CAR-T肝動脈注入和Sir-Spheres載藥系統(tǒng)

ClinicalTrials.gov Identifier 

注冊編號

NCT02416466

Sponsor

發(fā)起人/單位

Roger Williams Medical Center

羅杰·威廉斯醫(yī)療中心

Study Chair

研究主導(dǎo)者

Steven C Katz,

M.D.

Brief Summary

簡要描述

This is an open label fixed dose phase Ib of anti-CEA CAR-T cells hepatic artery infusions and yttrium-90 SIR-Spheres in patients with CEA-expressing liver metastases.

這是一個在CEA表達的肝轉(zhuǎn)移患者中進行的開放標(biāo)簽固定劑量臨床Ib期實驗，包括anti-CEA CAR-T細胞肝動脈注入和釔- 90 SIR-Spheres載藥系統(tǒng)的使用。

Recruiting objects

招募對象

18 Years and older（Liver Metastases）

18歲或者更大的肝轉(zhuǎn)移患者

Study Phase

研究階段

Phase 1

臨床1期

A Clinical Research of CAR T Cells Targeting CEA Positive Cancer.

靶向CEA陽性腫瘤的CAR T細胞臨床研究

ClinicalTrials.gov Identifier 

注冊編號

NCT02349724

Sponsor

發(fā)起人/單位

Southwest Hospital, China

西南醫(yī)院

Study Chair

研究主導(dǎo)者

Cheng Qian, MD, PhD

錢程博士

Brief Summary

簡要描述

The main purpose of this research is to verify the safety of CEA targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.

本次研究的主要目的是驗證靶向CEA的CAR-T細胞安全性和恰當(dāng)?shù)淖⑸鋭┝俊?/span>

Recruiting objects

招募對象

18-80 years（Lung Cancer 、Colorectal Cancer、Gastric Cancer、Breast Cancer、Pancreatic Cancer）

18-80歲的肺癌、腸癌、胃癌、乳腺癌、胰腺癌患者

Study Phase

研究階段

Phase 1

臨床1期

CAR-T Cell Immunotherapy in MUC1 Positive Solid Tumor.

靶向MUC 1陽性實體腫瘤的CAR T細胞免疫治療

ClinicalTrials.gov Identifier 

注冊編號

NCT02617134

Sponsor

發(fā)起人/單位

PersonGen Biomedicine (Suzhou) Co., Ltd.

博生吉生物醫(yī)藥科技（蘇州）有限公司

Principal Investigator

& Study Chair

首席研究員 & 研究主導(dǎo)者

Lin Yang, Ph.D.

楊林博士

Mingjin She, Ph.D.

佘明金博士

Brief Summary

簡要描述

The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor.

本次研究的主要目的是驗證靶向MUC 1的CAR-T細胞治療復(fù)發(fā)或難治性實體瘤的安全性和有效性。

Recruiting objects

招募對象

18-80 years（Malignant Glioma of Brain、Colorectal Carcinoma、Gastric Carcinoma）

18-80歲的惡性腦膠質(zhì)瘤、腸癌、胃癌患者

Study Phase

研究階段

Phase 1&Phase 2

臨床1期和2期

Phase I/II Study of Anti-Mucin1 (MUC1) CAR T Cells for Patients With MUC1+ Advanced Refractory Solid Tumor.

靶向MUC 1陽性的晚期難治性實體腫瘤的CAR T細胞免疫治療臨床I/II期研究

ClinicalTrials.gov Identifier 

注冊編號

NCT02587689

Sponsor

發(fā)起人/單位

PersonGen Biomedicine (Suzhou) Co., Ltd.

博生吉生物醫(yī)藥科技（蘇州）有限公司

Principal Investigator

& Study Chair

首席研究員 & 研究主導(dǎo)者

Lin Yang, Ph.D.

楊林博士

Brief Summary

簡要描述

The purpose of this study is to determine whether autologous T cells bearing chimeric antigen receptor that can specifically recognize (Mucin 1) MUC1 is safe and effective for patients with relapsed or refractory solid tumor.

本次研究的主要目的是驗證靶向MUC 1的CAR-T細胞治療復(fù)發(fā)或難治性實體瘤的安全性和有效性。

Recruiting objects

招募對象

18-70 years（Hepatocellular Carcinoma、Non-small Cell Lung Cancer、Pancreatic Carcinoma、Triple-Negative Invasive Breast Carcinoma）

18-70歲的肝細胞癌、非小細胞肺癌、胰腺癌癌,三陰乳腺浸潤性癌患者

Study Phase

研究階段

Phase 1&Phase 2

臨床1期和2期

CAR T Cells in Treating Patients With Malignant Gliomas Overexpressing EGFR.

靶向EGFR過表達的惡性神經(jīng)膠質(zhì)瘤CAR T細胞免疫治療

ClinicalTrials.gov Identifier 

注冊編號

NCT02331693

Sponsor

發(fā)起人/單位

RenJi Hospital

仁濟醫(yī)院

Principal Investigator

首席研究員 

Zonghai Li M.D.

李宗海博士

Brief Summary

簡要描述

The purpose of this study is to determine whether autologous T cells bearing chimeric antigen receptor that can specifically recognize EGFR overexpressed in tumor cells is safe and effective for patients with EGFR-overexpressing malignant glioma.

本次研究的主要目的是驗證靶向EGFR的CAR-T細胞治療惡性腦膠質(zhì)瘤的安全性和有效性。

Recruiting objects

招募對象

18-70 years（malignant glioma）

18-70歲的惡性腦膠質(zhì)瘤患者

Study Phase

研究階段

Phase 1

臨床1期

Study Evaluating the Efficacy and Safety With CAR-T for Liver Cancer (EECLC)

評估CAR-T細胞治療肝癌的安全性與有效性

ClinicalTrials.gov Identifier 

注冊編號

NCT02729493

Sponsor

發(fā)起人/單位

Sinobioway Cell Therapy Co., Ltd.

北大未名細胞治療中心

Principal Investigator

首席研究員 

Xianping Cheng

Brief Summary

簡要描述

This single-arm,multicenter Phase 2 trial will treat the patients who have relapsed or refractory liver cancer with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour cells that express the EPCAM protein on the cell surface.The study will determine if these modified T cells help the body's immune system eliminate tumour cells.The trial will also study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body and the impact of this treatment on survival.

這個單臂,多中心2期臨床試驗治療的病人是復(fù)發(fā)或難治性肝癌。注入病人自身的CAR-T細胞,靶點為腫瘤細胞表面表達的EPCAM蛋白。這項研究將確定這些修改的CAR-T細胞幫助人體免疫系統(tǒng)消滅腫瘤細胞。試驗還會研究CAR-T治療的安全性、CAR-T細胞在病人的身體存活時間和患者治療生存的影響。

Recruiting objects

招募對象

up to 75 Years（Liver Neoplasms）

大于75歲的肝臟腫瘤患者

Study Phase

研究階段

Phase 1&Phase 2

臨床1期和2期