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

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ClinicalTrials.gov Identifier: NCT03799913
Recruitment Status : Not yet recruiting
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Sponsor:
Collaborators:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hrain Biotechnology Co.,Ltd.
Information provided by (Responsible Party):
Zhigang Zhang, Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Biological: anti-MESO CAR-T cells Drug: Fludarabine Drug: Cyclophosphamide Early Phase 1

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
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial of MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

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




Primary Outcome Measures :
  1. Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 [ Time Frame: 1 years post infusion ]

Secondary Outcome Measures :
  1. Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm [ Time Frame: 12 months post infusion ]
  2. Progress Free Survival (PFS) after administration [ Time Frame: 12 months post infusion ]
  3. Duration of CAR-positive T cells in circulation [ Time Frame: 12 months post infusion ]
  4. Detection of PD1 antibody in serum [ Time Frame: 12 months post infusion ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799913


Contacts
Contact: Jianwei Zhou, M.D. 057-89713634 jianwei-zhou@163.com

Locations
China, Zhejiang
The Second Affiliated hospital of Zhejiang University School of Medicine Not yet recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Jianwei Zhou, M.D.    0571-89713634    jianwei-zhou@163.com   
Sponsors and Collaborators
Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hrain Biotechnology Co.,Ltd.

Responsible Party: Zhigang Zhang, Dr, Zhejiang University
ClinicalTrials.gov Identifier: NCT03799913     History of Changes
Other Study ID Numbers: MESO
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhigang Zhang, Zhejiang University:
CAR-T
MESO
Ovarian Cancer
Relapsed and Refractory

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists