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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 : March 18, 2020
Sponsor:
Collaborator:
Hrain Biotechnology Co., Ltd.
Information provided by (Responsible Party):
Zhao Hui, Shanghai 6th People's Hospital

Tracking Information
First Submitted Date  ICMJE January 18, 2019
First Posted Date  ICMJE January 24, 2019
Last Update Posted Date March 18, 2020
Actual Study Start Date  ICMJE August 16, 2019
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
  • Cmax [ Time Frame: 30 days post infusion ]
    the highest concentration (Cmax) of anti-human MESO T cells in the peripheral blood after administration
  • 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
  • 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
  • Duration of Mesothelin-positive T cells in circulation [ Time Frame: 90 days post infusion ]
    Duration of Mesothelin-positive T cells in circulation
  • ORR [ Time Frame: 3 months post infusion ]
    Overall response rate after administration
  • PFS [ Time Frame: 1 year post infusion ]
    Progress Free Survival after administration
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Fourth Generation CART-cell Therapy for Refractory-Relapsed Ovarian Cancer
Official Title  ICMJE The Clinical Research of Fourth Generation CART-cell Therapy in Refractory-Relapsed Ovarian Cancer
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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).
Interventions:
  • Drug: anti- MESO CAR-T cells
  • Drug: Fludarabine
  • Drug: Cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 18, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hui Zhao, doctor 021-64369181 ivy25502@hotmail.com
Contact: Yincheng Teng, doctor 021-64369181 teng_yc@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03814447
Other Study ID Numbers  ICMJE MESO-CART
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zhao Hui, Shanghai 6th People's Hospital
Study Sponsor  ICMJE Shanghai 6th People's Hospital
Collaborators  ICMJE Hrain Biotechnology Co., Ltd.
Investigators  ICMJE
Principal Investigator: Hui Zhao, doctor Shanghai 6th People's Hospital
PRS Account Shanghai 6th People's Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP