The Fourth Generation CART-cell Therapy for Refractory-Relapsed Ovarian Cancer

August 9, 2021 updated by: Zhao Hui, Shanghai 6th People's Hospital

The Clinical Research of Fourth Generation CART-cell Therapy in Refractory-Relapsed Ovarian Cancer

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yincheng Teng, doctor
  • Phone Number: 021-64369181
  • Email: teng_yc@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai 6th People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • FA
Drug: Cyclophosphamide
Dose: 300mg/m2/d
Other Names:
  • CTX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year post infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 30 days post infusion
the highest concentration (Cmax) of anti-human MESO T cells in the peripheral blood after administration
30 days post infusion
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
30 days post infusion
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
30 days post infusion
Duration of Mesothelin-positive T cells in circulation
Time Frame: 90 days post infusion
Duration of Mesothelin-positive T cells in circulation
90 days post infusion
ORR
Time Frame: 3 months post infusion
Overall response rate after administration
3 months post infusion
PFS
Time Frame: 1 year post infusion
Progress Free Survival after administration
1 year post infusion
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)
1 year post infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 6th People's Hospital

Collaborators

Hrain Biotechnology Co., Ltd.

Investigators

  • Principal Investigator: Hui Zhao, doctor, Shanghai 6th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2019

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

January 18, 2019

First Submitted That Met QC Criteria

January 18, 2019

First Posted (Actual)

January 24, 2019

Study Record Updates

Last Update Posted (Actual)

August 10, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MESO-CART

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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