NCT03356795

Brief Summary

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells immunotherapy in patients who have GD2, PSMA, Muc1, Mesothelin or other markers positive cervical cancer. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.

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 Nov 2017

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

November 15, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

1.2 years

First QC Date

November 24, 2017

Last Update Submit

September 18, 2019

Conditions

Cervical Cancer

Keywords

Cervical cancerCAR-TGD2PSMAMuc1MesothelinHPVsolid tumor

Outcome Measures

Primary Outcomes (1)

  • Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events

    Physiological parameter (measuring cytokine response)

    3 months

Secondary Outcomes (2)

  • Persistence and proliferation of CART cells in patients

    3 months

  • Anti-tumor effects

    1 year

Study Arms (1)

Cervical cancer-specific CAR-T cells

EXPERIMENTAL

Peripheral blood mononuclear cells (PBMCs) of patients who have GD2, PSMA, Muc1 or Mesothelin positive cervical cancer will be obtained through apheresis, and T cells will be activated and modified to cervical cancer-specific CAR-T cells.

Biological: Cervical cancer-specific CAR-T cells

Interventions

Cervical cancer-specific CAR-T cellsBIOLOGICAL

1 infusion, for 1x10\^6\~1x10\^7 cells/kg via IV

Cervical cancer-specific CAR-T cells

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with stage III, IV or relapsed cervical cancer confirmed by histology and biopsy.
  • Age: ≥ 18 years and ≤ 70 years.
  • weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.
  • Side Effects of Chemotherapy have subsided.
  • GD2, PSMA, Muc1, Mesothelin or other markers is expressed high (above 2+) in malignancy tissues by immuno-histochemical or flow cytometry.
  • Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
  • Expected survival ≥ 12 weeks.
  • Initial hematopoietic reconstitution with
  • neutrophils (ANC) ≥ 1×10\^6/L;
  • platelet (PLT) ≥ 1×10\^8/L.
  • Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
  • serum creatinine ≤ 2×ULN;
  • serum bilirubin ≤ 3×ULN;
  • AST/ALT ≤ 2.5×ULN.
  • Oxygen saturation ≥ 90%.
  • +1 more criteria

You may not qualify if:

  • Airway obstruction caused by tumor.
  • History of epilepsy or other central nervous system diseases.
  • Patients who require systemic corticosteroid or other immunosuppressive therapy.
  • History of prolonged or serious heart disease during QT.
  • history of serious cyclophosphamide toxicity.
  • Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
  • Inadequate liver and renal function with
  • serum creatinine \> 1.5 mg/dl;
  • serum (total) bilirubin \> 2.0 mg/dl;
  • AST \& ALT \> 3 x ULN.
  • Pregnant or lactating females.
  • Serious active infection during screening.
  • Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.
  • Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical NeoplasmsMedullary cystic kidney disease 1

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Lung-Ji Chang, PhD

    Shenzhen Geno-Immune Medical Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lung-Ji Chang, PhD

CONTACT

86-075586725195c@szgimi.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

November 24, 2017

First Posted

November 29, 2017

Study Start

November 15, 2017

Primary Completion

January 31, 2019

Study Completion

December 1, 2020

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)