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The Fourth Generation CART-cell Therapy for Refractory-Relapsed 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03814447
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : August 10, 2021
Sponsor:
Collaborator:
Hrain Biotechnology Co., Ltd.
Information provided by (Responsible Party):
Zhao Hui, Shanghai 6th People's Hospital

Study Description
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Brief Summary:
The goal of this clinical trial is to study the safety and feasibility of anti- Mesothelin Chimeric Antigen Receptor T-Cell (MESO CAR-T cells) therapy for Refractory-Relapsed Ovarian Cancer

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

Detailed Description:

Primary Objectives:

1. To determine the safety and feasibility of anti- MESO CAR-T cells therapy for Refractory-Relapsed 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
  3. To assess the quality of life in patients with ovarian cancer after treatment with anti- MESO CAR-T cells.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Research of Fourth Generation CART-cell Therapy in Refractory-Relapsed Ovarian Cancer
Actual Study Start Date : August 16, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: anti- MESO CAR-T cells
The subjects in this arm will receive Cyclophosphamide 300mg/m2/d and Fludarabine 30mg/m2/d d-4~-2. Then anti- MESO CAR-T cells will be injected by a dose of 5×106/kg once at d1(rang from d1-3).
 Drug: anti- MESO CAR-T cells
Autologous genetically modified anti- MESO CAR transduced T cells

Drug: Fludarabine
Dose: 30mg/m2/d
Other Name: FA

Drug: Cyclophosphamide
Dose: 300mg/m2/d
Other Name: CTX


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events (AEs) and Serious adverse event (SAEs) [ Time Frame: 1 year post infusion ]
    Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.03


Secondary Outcome Measures :
  1. Cmax [ Time Frame: 30 days post infusion ]
    the highest concentration (Cmax) of anti-human MESO T cells in the peripheral blood after administration

  2. Tmax [ Time Frame: 30 days post infusion ]
    the time to reach the highest concentration (Tmax) of anti-human MESO T cells in the peripheral blood after administration

  3. AUC(0-30d) [ Time Frame: 30 days post infusion ]
    the area under the curve of 30 days of anti-human MESO T cells in the peripheral blood after administration

  4. Duration of Mesothelin-positive T cells in circulation [ Time Frame: 90 days post infusion ]
    Duration of Mesothelin-positive T cells in circulation

  5. ORR [ Time Frame: 3 months post infusion ]
    Overall response rate after administration

  6. PFS [ Time Frame: 1 year post infusion ]
    Progress Free Survival after administration

  7. EORTC Quality-of-Life Questionnaire Core 15 Palliative Care (QLQ-C15-PAL) of patients after administration [ Time Frame: 1 year post infusion ]
    This QLQ-C15-PAL score consists of 15 questions; two multi-item functional scales (physical and emotional functioning), two multi-item symptom scales (fatigue and pain) together with five single-item symptom scales (nausea/vomiting, dyspnea, insomnia, appetite loss, constipation) and one final question referring to overall QOL. The physical functioning scale is based on three questions regarding walking, activities of daily living and time spent in bed or in a chair. The emotional functioning scale is based on two questions that ask about feeling tense or depressed. Patients rated each question on a Likert scale from 1 (not at all) to 4 (very much), with the exception of overall QOL, which was rated from 1 (very poor) to 7 (excellent)


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histopathologically confirmed ovarian cancer;
  2. 18-75 Years Old, female;
  3. Expected survival > 12 weeks;
  4. Eastern Cooperative Oncology Group (ECOG) score 0-2;
  5. Patients who have previously been treated with second- line or above standard treatment are failed (progress in treatment or recurrence within 6 months after discontinuation of treatment);
  6. According to the Immune-Modified Response Evaluation Criteria In Solid Tumors (imRECIST) , there should be at least one measurable tumor foci；
  7. Positive expression of Mesothelin in tumor tissue；
  8. Creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60ml / min;
  9. alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN , such as with liver metastasis, ≤ 5×ULN;
  10. Total bilirubin ≤ 2×ULN;
  11. Hemoglobin≥90g/L(No blood transfusion within 14 days);
  12. Absolute value of neutrophils ≥1.5×10^9/L;
  13. Absolute counting of lymphocytes >0.7×10^9/L;
  14. Counting of Platelet≥80×10^9/L；
  15. The venous access required for collection can be established without contraindications for leukocyte collection;
  16. 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. Insufficient function of important organs (heart, lung);
  4. Any other uncontrolled active disease that impedes participation in the trial;
  5. Any affairs could affect the safety of the subjects or purpose 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 within 14 days or 14 days prior to enrollment；
  8. The investigator believes that it is not appropriate to participate in the trial;
  9. Received CAR-T treatment or other gene therapies before enrollment; Subjects suffering disease affect the understanding of informed consent or unable to comply with study; Unwilling or unable to comply with study requirements.
Contacts and Locations
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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): NCT03814447


Contacts
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Contact: Hui Zhao, doctor 021-64369181 ivy25502@hotmail.com
Contact: Yincheng Teng, doctor 021-64369181 teng_yc@126.com

Locations
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China, Shanghai
Shanghai 6th People's Hospital Recruiting
Shanghai, Shanghai, China
Contact: Hui Zhao    021-64369181    ivy25502@hotmail.com   
Sponsors and Collaborators
Shanghai 6th People's Hospital
Hrain Biotechnology Co., Ltd.
Investigators
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Principal Investigator: Hui Zhao, doctor Shanghai 6th People's Hospital
More Information
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Responsible Party: Zhao Hui, professor, Shanghai 6th People's Hospital
ClinicalTrials.gov Identifier: NCT03814447    
Other Study ID Numbers: MESO-CART
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhao Hui, Shanghai 6th People's Hospital:
MESO
CAR-T
Ovarian cancer
Refractory-Relapsed
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
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