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Intervention of CAR-T Against Cervical Cancer

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ClinicalTrials.gov Identifier: NCT03356795
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute

Brief Summary:
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells immunotherapy in patients who have GD2, PSMA, Muc1, Mesothelin or other markers positive cervical cancer. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.

Condition or disease Intervention/treatment Phase
Cervical Cancer Biological: Cervical cancer-specific CAR-T cells Phase 1 Phase 2

Detailed Description:

Cervical cancer is a cancer arising from the cervix. Human papillomavirus (HPV) infection causes more than 90% of cases. Other risk factors include smoking, a weak immune system, birth control pills, starting sex at a young age, and having many sexual partners, but these are less important. Worldwide, cervical cancer is both the fourth-most common cause of cancer and the fourth-most common cause of death from cancer in women. The treatment of cervical cancer consists of surgical intervention, radiation, chemotherapy and immunotherapy.

In this study, the participant's T-cells will be collected and modified. Then the modified T cells, called chimeric antigen receptor modified-T cells (CAR T) which can recognize specific molecules that are expressed on the surface of cervical cancer cells, are given back to the participant by intravenous infusion.

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells immunotherapy in patients who have GD2, PSMA, Muc1, Mesothelin or other markers positive cervical cancer. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Trial of Chimeric Antigen Receptor-Modified T Cells (CAR-T Cells) in the Treatment of Cervical Cancer
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : January 31, 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Cervical cancer-specific CAR-T cells
Peripheral blood mononuclear cells (PBMCs) of patients who have GD2, PSMA, Muc1 or Mesothelin positive cervical cancer will be obtained through apheresis, and T cells will be activated and modified to cervical cancer-specific CAR-T cells.
Biological: Cervical cancer-specific CAR-T cells
1 infusion, for 1x10^6~1x10^7 cells/kg via IV




Primary Outcome Measures :
  1. Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events [ Time Frame: 3 months ]
    Physiological parameter (measuring cytokine response)


Secondary Outcome Measures :
  1. Persistence and proliferation of CART cells in patients [ Time Frame: 3 months ]
    The expansion and functional persistence of CART cells in the peripheral blood of patients will be measured by qPCR on Day 7, 14, 21, 28, 60 and 90 after infusion.

  2. Anti-tumor effects [ Time Frame: 1 year ]
    Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.



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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. Patients with stage III, IV or relapsed cervical cancer confirmed by histology and biopsy.
  2. Age: ≥ 18 years and ≤ 70 years.
  3. 4 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.
  4. Side Effects of Chemotherapy have subsided.
  5. GD2, PSMA, Muc1, Mesothelin or other markers is expressed high (above 2+) in malignancy tissues by immuno-histochemical or flow cytometry.
  6. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
  7. Expected survival ≥ 12 weeks.
  8. Initial hematopoietic reconstitution with

    • neutrophils (ANC) ≥ 1×10^6/L;
    • platelet (PLT) ≥ 1×10^8/L.
  9. Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with

    • serum creatinine ≤ 2×ULN;
    • serum bilirubin ≤ 3×ULN;
    • AST/ALT ≤ 2.5×ULN.
  10. Oxygen saturation ≥ 90%.
  11. Written, informed consent obtained prior to any study-specific procedures.

Exclusion Criteria:

  1. Airway obstruction caused by tumor.
  2. History of epilepsy or other central nervous system diseases.
  3. Patients who require systemic corticosteroid or other immunosuppressive therapy.
  4. History of prolonged or serious heart disease during QT.
  5. history of serious cyclophosphamide toxicity.
  6. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
  7. Inadequate liver and renal function with

    • serum creatinine > 1.5 mg/dl;
    • serum (total) bilirubin > 2.0 mg/dl;
    • AST & ALT > 3 x ULN.
  8. Pregnant or lactating females.
  9. Serious active infection during screening.
  10. Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.
  11. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

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): NCT03356795


Contacts
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Contact: Lung-Ji Chang, PhD 86-075586725195 c@szgimi.org

Locations
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China, Guangdong
Shenzhen Geno-immune Medical Institute Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, PhD    86-075586725195    c@szgimi.org   
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
Investigators
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Principal Investigator: Lung-Ji Chang, PhD Shenzhen Geno-Immune Medical Institute

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Responsible Party: Lung-Ji Chang, President, Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT03356795     History of Changes
Other Study ID Numbers: GIMI-IRB-17017
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
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 Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute:
Cervical cancer
CAR-T
GD2
PSMA
Muc1
Mesothelin
HPV
solid tumor
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female