NCT03799913

Brief Summary

The goal of this clinical trial is to study the feasibility and efficacy of anti-MESO antigen receptors (CARs) T cell therapy for relapsed and refractory ovarian cancer.

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 early_phase_1 ovarian-cancer

Timeline
Completed

Started Apr 2019

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

First Submitted

Initial submission to the registry

January 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 10, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

January 8, 2019

Last Update Submit

April 9, 2019

Conditions

Ovarian Cancer

Keywords

CAR-TMESOOvarian CancerRelapsed and Refractory

Outcome Measures

Primary Outcomes (1)

  • Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0

    1 years post infusion

Secondary Outcomes (4)

  • Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm

    12 months post infusion

  • Progress Free Survival (PFS) after administration

    12 months post infusion

  • Duration of CAR-positive T cells in circulation

    12 months post infusion

  • Detection of PD1 antibody in serum

    12 months post infusion

Study Arms (1)

anti-MESO CAR-T cells

EXPERIMENTAL

Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients

Biological: anti-MESO CAR-T cellsDrug: FludarabineDrug: Cyclophosphamide

Interventions

anti-MESO CAR-T cellsBIOLOGICAL

Retroviral vector-transduced autologous T cells to express anti-MESO CARs

anti-MESO CAR-T cells
FludarabineDRUG

30mg/m2/d

anti-MESO CAR-T cells
CyclophosphamideDRUG

300mg/m2/d

anti-MESO CAR-T cells

Eligibility Criteria

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

You may qualify if:

  • to 70 Years Old, female;
  • Expected survival \> 12 weeks;
  • Clinical performance status of ECOG score 0-2;
  • Patients who have previously been treated with second- line or more lines of standard treatment are not effective (No remission or recurrence after remission);
  • At least one measurable tumor foci according to RECIST standard 1.1 ;
  • Positive Mesothelin expression in tumor tissues;
  • Creatinine ≤ 1.5×ULN;
  • ALT and AST ≤ 3×ULN;
  • Total bilirubin ≤ 2×ULN;
  • Hemoglobin≥90g/L;
  • Absolute counting of neutrophils≥1000uL ;
  • Absolute counting of lymphocytes\>0.7×10\^9/L;
  • Counting of Platelet≥75000/uL;
  • The venous access required for collection can be established without contraindications for leukocyte collection;
  • Able to understand and sign the Informed Consent Document.

You may not qualify if:

  • Accompanied by other uncontrolled malignant tumors;
  • Active hepatitis B, hepatitis C, syphilis, HIV infection;
  • Suffering severe cardiovascular or respiratory disease;
  • Any other diseases could affect the outcome of this trial;
  • Any affairs could affect the safety of the subjects or outcome of this trial;
  • Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment;
  • There are active or uncontrollable infections (except simple urinary tract infections or upper respiratory tract infections) that require systemic therapy 14 days or 14 days prior to assignment;
  • Patients who are accounted by researchers to be not appropriate for this test;
  • Received CAR-T treatment or other gene therapies before assignment;
  • Subject suffering disease affects the understanding of informed consent or comply with study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Ovarian NeoplasmsRecurrence

Interventions

fludarabineCyclophosphamide

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Jianwei Zhou, M.D.

    Zhejiang University

    STUDY CHAIR

Central Study Contacts

Zhigang Zhang, M.D.

CONTACT

86+057189713631zzg2011@zju.edu.cn

Study Design

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

Study Record Dates

First Submitted

January 8, 2019

First Posted

January 10, 2019

Study Start

April 10, 2019

Primary Completion

October 1, 2021

Study Completion

April 1, 2022

Last Updated

April 10, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)