MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03799913 |
Recruitment Status : Unknown
Verified April 2019 by Zhigang Zhang, Zhejiang University.
Recruitment status was: Recruiting
First Posted : January 10, 2019
Last Update Posted : April 10, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer | Biological: anti-MESO CAR-T cells Drug: Fludarabine Drug: Cyclophosphamide | Early Phase 1 |
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
- 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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
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 : | April 10, 2019 |
Estimated Primary Completion Date : | October 2021 |
Estimated Study Completion Date : | April 2022 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Zhigang Zhang, M.D. | 86+057189713631 | zzg2011@zju.edu.cn |
China, Zhejiang | |
The Second Affiliated hospital of Zhejiang University School of Medicine | Recruiting |
Hangzhou, Zhejiang, China, 310009 | |
Contact: Jianwei Zhou, M.D. 0571-89713634 jianwei-zhou@163.com |
Study Chair: | Jianwei Zhou, M.D. | Zhejiang University |
Responsible Party: | Zhigang Zhang, Dr, Zhejiang University |
ClinicalTrials.gov Identifier: | NCT03799913 |
Other Study ID Numbers: |
MESO |
First Posted: | January 10, 2019 Key Record Dates |
Last Update Posted: | April 10, 2019 |
Last Verified: | April 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 |
CAR-T MESO Ovarian Cancer Relapsed and Refractory |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial |
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 |