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

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

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.

Study Overview

• Status: Unknown
• Conditions: Ovarian Cancer
• Intervention / Treatment: Biological: anti-MESO CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Jianwei Zhou, M.D.; Phone Number: 0571-89713634; Email: jianwei-zhou@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: anti-MESO CAR-T cells; Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients	Biological: anti-MESO CAR-T cells; Retroviral vector-transduced autologous T cells to express anti-MESO CARs; Drug: Fludarabine; 30mg/m2/d; Drug: Cyclophosphamide; 300mg/m2/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0	1 years post infusion

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Zhejiang University
• Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University; Hrain Biotechnology Co., Ltd.
• Investigators: Study Chair: Jianwei Zhou, M.D., Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 10, 2019
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: CAR-T; Ovarian Cancer; MESO; Relapsed and Refractory
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Cyclophosphamide; Fludarabine
• Other Study ID Numbers: MESO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No