NCT03130712

Brief Summary

In this study, CART cells are targeted to GPC3 by intratumor injected that we hope by this means could improve the local CAR-T cell numbers, meanwhile reduce the potential side effects.

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
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2017

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

April 1, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

12 months

First QC Date

April 22, 2017

Last Update Submit

April 22, 2017

Conditions

Carcinoma, Hepatocellular

Keywords

immunotherapyGPC3-CARTHCC

Outcome Measures

Primary Outcomes (1)

  • Safety of CAR-T cell infusion mediated by intratumoral injection as measured by number of participants with adverse Events

    To determine the safety and regimen limiting toxicity (RLT) of anti-GPC3 CAR-T intratumoral injection for GPC3-expressing HCC.

    6 weeks

Secondary Outcomes (2)

  • Number of participants with tumor response as measured by RECIST

    8 weeks]

  • Serum cytokine levels

    8 weeks

Study Arms (1)

GPC3-CART cells

EXPERIMENTAL
Drug: GPC3-CART cells

Interventions

GPC3-CART cellsDRUG

Intratumol injection as a local drug delivery pathway, so that more T cells gathered at the tumor site, less T cells to migrated to the normal tissue, thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects. And GPC3-CART is a 2nd CAR, with GPC3 as the target protein, 4-1BB as a co- stimulator

GPC3-CART cells

Eligibility Criteria

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

You may qualify if:

  • Advanced HCC patients with age between 18 and 69 years old;
  • Persistent cancer after at least one prior standard of chemotherapy or surgery, and without high level evidence of second-line treatment;
  • The intended intratumoral injection sites of tumor can be showed clear by CT or ultrasound scan, and safe access to without important neuromuscular pass;
  • The ECOG score less than 1 points, and the expected survival more than 4 months;
  • Recovery from previous treatment: all side effects (except hair loss) were reduced to level 1 or below, according to NCI-CTC AE version 4;
  • Pregnancy test (urine beta -HCG) negative (for women of childbearing age);
  • Meet one of the following conditions:
  • GPC3 was expressed in more than 15% of tumor cells (immunohistochemical method)
  • GPC3 expression in more than 30% of tumor cells (flow cytometry);
  • Satisfactory organ and bone marrow function as defined by the following: (1) creatinine \<1.5mg/dl; (2) albumin \>2; (3) cardiac ejection fraction of \>55%; (4) hemoglobin\>9g/dl, bilirubin 2.0×the institution normal upper limit;
  • Adequate venous access for apheresis;
  • Voluntary informed consent.

You may not qualify if:

  • Pregnant or lactating women, urine pregnancy test was positive before transplantation of CAR-T cells 48 hours;
  • 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;
  • Forced position, can not be adjusted according to requirements;
  • Severe heart, lung, liver, kidney function, blood coagulation dysfunction;
  • 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)

302 Military Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lu Yinying, Doctor

    Beijing 302 Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Yinying, Doctor

CONTACT

13301256799luyinying1973@163.com

Yu Xuejun, Master

CONTACT

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

April 22, 2017

First Posted

April 26, 2017

Study Start

April 1, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

CN(1)