MESO-CAR T Cells Therapy for Relapsed and Refractory Epithelial Ovarian Cancer

NCT ID: NCT03916679

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-20
• Study Completion Date: 2023-04-20

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 epithelial ovarian cancer.

Detailed Description

Primary Objectives

To determine the feasibility ad safety of anti-MESO CAR-T cells in treating patients with MESO-positive ovarian cancer.

Secondary Objectives

To access the efficacy of anti-MESO CAR-T cells in patients with ovarian cancer.

To determine in vivo dynamics and persistency of anti- MESO CAR-T cells.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

anti-MESO CAR-T cells

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

Group Type: EXPERIMENTAL

anti-MESO CAR-T cells

Intervention Type: BIOLOGICAL

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

Interventions

anti-MESO CAR-T cells

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Fludarabine 30mg/m2/d; Cyclophosphamide 300mg/m2/d

Eligibility Criteria

Inclusion Criteria

• 18 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianwei Zhou, M.D.

Role: STUDY_CHAIR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhigang Zhang, M.D.

Role: CONTACT

zzg2011@zju.edu.cn

15088621550

Jianwei Zhou, M.D.

Role: CONTACT

jianwei-zhou@163.com

0571-89713634

Facility Contacts

Zhigang Zhang, M.D.

Role: primary

zzg2011@zju.edu.cn

15088621550

Other Identifiers

MESO-OS

Identifier Type: -

Identifier Source: org_study_id