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

Ovarian Cancer Clinical Trial

Official title:

A Clinical Trial of MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03799913
• Other study ID #: MESO
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 10, 2019
• Est. completion date: April 2022

Study information

• Verified date: April 2019
• Source: Zhejiang University
• Contact: Zhigang Zhang, M.D.
• Phone: 86+057189713631
• Email: zzg2011[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Primary Objectives

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

Secondary Objectives

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 18 to 70 Years Old, female;

2. Expected survival > 12 weeks;

3. Clinical performance status of ECOG score 0-2;

4. Patients who have previously been treated with second- line or more lines of standard treatment are not effective (No remission or recurrence after remission);

5. At least one measurable tumor foci according to RECIST standard 1.1 ;

6. Positive Mesothelin expression in tumor tissues;

7. Creatinine = 1.5×ULN;

8. ALT and AST = 3×ULN;

9. Total bilirubin = 2×ULN;

10. Hemoglobin=90g/L;

11. Absolute counting of neutrophils=1000uL ;

12. Absolute counting of lymphocytes>0.7×10^9/L;

13. Counting of Platelet=75000/uL;

14. The venous access required for collection can be established without contraindications for leukocyte collection;

15. Able to understand and sign the Informed Consent Document.

Exclusion Criteria:

1. Accompanied by other uncontrolled malignant tumors;

2. Active hepatitis B, hepatitis C, syphilis, HIV infection;

3. Suffering severe cardiovascular or respiratory disease;

4. Any other diseases could affect the outcome of this trial;

5. Any affairs could affect the safety of the subjects or outcome of this trial;

6. Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment;

7. 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;

8. Patients who are accounted by researchers to be not appropriate for this test;

9. Received CAR-T treatment or other gene therapies before assignment;

10. Subject suffering disease affects the understanding of informed consent or comply with study protocol.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Biological:
• anti-MESO CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-MESO CARs

Drug:
• Fludarabine
30mg/m2/d
• Cyclophosphamide
300mg/m2/d

Locations

Country	Name	City	State
China	The Second Affiliated hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Zhejiang University	Hrain Biotechnology Co., Ltd., Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0		1 years post infusion
Secondary	Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm		12 months post infusion
Secondary	Progress Free Survival (PFS) after administration		12 months post infusion
Secondary	Duration of CAR-positive T cells in circulation		12 months post infusion
Secondary	Detection of PD1 antibody in serum		12 months post infusion