NCT02959151

Brief Summary

The purpose of this study is to collect the date on the safety and potential effectiveness of CART cells combined with interventional therapy in patients with advanced liver malignancy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

November 6, 2016

Last Update Submit

November 7, 2016

Conditions

Carcinoma, HepatocellularPancreatic Cancer MetastaticColorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse event

    adverse event is evaluated with CTCAE, version 4.0

    6 weeks

Secondary Outcomes (2)

  • Number of patients with tumor response

    8 weeks

  • Detection of transferred T cells in the circulation using quantitative -PCR

    8 weeks

Study Arms (1)

CAR-T for liver cancer

EXPERIMENTAL

A single dose of CART cells will be administered by vascular interventional therapy or by intra-tumor injection with a dose of （1.25\~4）×107 CAR positive T cells/cm3 tumor bulk. The volume of cell products and the time of cell perfusion process lasted would depend on the ways of cell perfused. And an interventional radiologist would operate the cell infusion.

Drug: CAR-T cell

Interventions

CAR-T cellDRUG

CAR-T cells are generated by T cells from the patients or a suitable donor transfected by CAR-lentivirus vectors. There are three options for CAR-targets: GPC3 for hepatocellular carcinoma;mesothelin for pancreatic cancer metastatic; CEA for colorectal cancer metastatic.

Also known as: chimeric antigen receptor T cells
CAR-T for liver cancer

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • tumor histological examination confirmed as GPC3/ mesothelin/CEA positive expression;
  • persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients
  • life expectancy greater than 6 months
  • satisfactory organ and bone marrow function as defined by the following: (1) creatinine \<1.5mg/dl; (2) cardiac ejection fraction of \>55%; (3) hemoglobin\>9g/dl, bilirubin 2.0×the institution normal upper limit
  • without bleeding disorder or coagulation disorders
  • Don't allergy to Radiocontrast agent
  • birth control
  • Adequate venous access for apheresis, and no other contraindications for leukapheresis
  • Voluntary informed consent is given

You may not qualify if:

  • Pregnant or lactating women
  • patients in the situation of: (1) 30 days before apheresis is still in the period of other antitumor drug observation; (2) patient dont recuperate from earlier acute adverse influence brought by any treatments accepted before
  • Four weeks before recruit accepted radiation therapy
  • Previously treatment with any gene therapy products
  • Feasibility assessment during screening demonstrates\<30% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to CD3/CD28 costimulation
  • Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, CNS diseases)
  • Patient with severe acute hypersensitive reaction
  • Taking part in other clinical trials
  • Study leader considers not suitable for this tiral

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tumor Hospital

Shanghai, Shanghai Municipality, 201206, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Wentao Li, doctor

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wentao Li, doctor

CONTACT

+86 18017312650liwentao98@126.com

Xuejun Yu, master

CONTACT

+86 18616108610yuxuejun@genechem.com.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2016

First Posted

November 8, 2016

Study Start

July 1, 2016

Primary Completion

January 1, 2018

Study Completion

July 1, 2018

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

CN(1)