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Engineered Immune Effectors Against Cervical 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: NCT03362619
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute

Brief Summary:
The primary objective of this study is to evaluate the safety of cervical cancer specific engineered immune effectors (CC-EIEs). The secondary objectives are to evaluate the rate of successful CC-EIE generation in vitro and determine the anti-CC efficacy.

Condition or disease Intervention/treatment Phase
Cervical Cancer Biological: CC-EIEs Phase 1 Phase 2

Detailed Description:

Cervical cancer (CC) is a cancer arising from the cervix. Human papillomavirus (HPV) infection causes more than 90% of the 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, CC is both the fourth-most common cause of cancer and the fourth-most common cause of death from cancer in women. The treatment of CC consists of surgical intervention, radiation, chemotherapy and immunotherapy.

Adoptive immunotherapy with cytotoxic T lymphocytes reactive with specific viral antigens has proven to be effective. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of CC-specific engineered immune effectors including cytotoxic T lymphocytes in patients.

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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: Innovative Treatment of Cervical Cancer Using Engineered Antigen-specific Immune Effectors (EIEs)
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: CC-EIEs
Autologous cervical cancer specific engineered immune effectors (EIEs)
Biological: CC-EIEs
2 to 4 infusions, once a week, for 1x10^5~1x10^7 CTLs/kg via IV, abdominal cavity or intratumoral injection each time




Primary Outcome Measures :
  1. Safety of CC-EIEs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events [ Time Frame: 6 months ]
    Physiological parameter (measuring cytokine response, fever, symptoms)


Secondary Outcome Measures :
  1. Functional analyses of CC-EIEs in vitro [ Time Frame: 4 weeks ]
    The specificity of CC-EIEs in vitro will be analysed by enzyme-linked immunospot assay (ELISPOT).

  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written, informed consent obtained prior to any study-specific procedures.
  2. Age older than 10 years.
  3. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
  4. Expected survival ≥ 12 weeks.
  5. Not pregnant, and on appropriate birth control if of childbearing potential.
  6. Evidence of high-risk HPV infection.
  7. Stage III-IV or recurrent cervical cancer.
  8. Initial hematopoietic reconstitution with

    • neutrophils (ANC) ≥ 1,000/mm^3;
    • platelet (PLT) ≥ 100,000/mm^3.
  9. Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with

    • serum creatinine ≤ 2×ULN;
    • serum bilirubin ≤ 2×ULN;
    • AST/ALT ≤ 2×ULN;
    • ALKP ≤ 5×ULN;
    • serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.
  10. Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test negative.

Exclusion Criteria:

  1. Patients with

    • cervical benign lesions: cervical columnar epithelium ectopic, cervical polyps, cervical endometriosis and cervical tuberculous ulcers;
    • cervical benign tumors: cervical submucous myoma, cervical cancer, cervical papilloma.
  2. Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).
  3. Previous exposure to mouse SCC antibody.
  4. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
  5. Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).
  6. Pregnant or lactating females.
  7. Inadequate bone marrow function with

    • absolute neutrophil count < 1,000/mm^3;
    • platelet count < 100,000/mm^3;
    • Hb < 9 g/dL.
  8. Inadequate liver and renal function with

    • serum (total) bilirubin > 1.5 x ULN;
    • AST & ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases);
    • alkaline phosphatase > 2.5 x ULN;
    • serum creatinine >2.0 mg/dl (> 177 μmol/L);
    • urine dipstick for protein uria should be < 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate < 1 g of protein/24 hr.
  9. Serious active infection requiring i.v. antibiotics at during screening.
  10. Subject actively infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.

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): NCT03362619


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

Locations
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China, Guangdong
Jinshazhou Hospital of Guangzhou University of Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510415
Contact: Qichun Cai, MD    86-13802830754      
Shenzhen Geno-immune Medical Institute Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, PhD    86-075586725195    c@szgimi.org   
China, Yunnan
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center Recruiting
Kunming, Yunnan, China, 650000
Contact: Xun Lai, MD    13577096609    1729112214@qq.com   
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
Investigators
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Principal Investigator: Lung-Ji Chang, PhD Shenzhen Geno-Immune Medical Institute
Study Director: Qichun Cai, MD Jinshazhou Hospital of Guangzhou University of Chinese Medicine
Study Director: Xun Lai, MD Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center
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Responsible Party: Lung-Ji Chang, President, Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT03362619    
Other Study ID Numbers: GIMI-IRB-17019
First Posted: December 5, 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
Cytotoxic lymphocyte
CC-CTL
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