ClinicalTrials.gov
ClinicalTrials.gov Menu

Engineered Immune Effectors Against 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: NCT03362606
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute

Brief Summary:
This is a single-arm, open-label, phase I/II trial to evaluate the safety and efficacy of ovarian cancer specific cytotoxic lymphocytes (OC-CTLs) in women.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Biological: OC-CTLs Phase 1 Phase 2

Detailed Description:

Ovarian cancer is a cancer that forms in or on an ovary. The majority of ovarian cancers arise from the epithelium (outer lining) of the ovary. In 2015 it was reported found in 1.2 million women and resulted in 161,100 deaths worldwide. Among women it is the seventh-most common cancer and the eighth-most common cause of death from cancer. Treatment for ovarian cancer consists of surgery, chemotherapy, immunotherapy and sometimes, radiotherapy. The kind of treatment depends on many factors, including the type of ovarian cancer, its stage and grade, as well as the general health of the patient.

Adoptive immunotherapy with cytotoxic T lymphocytes (CTLs) reactive with specific viral antigens has proven to be effective. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of ovarian cancer specific cytotoxic T lymphocytes in patients.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intervention of Ovarian Cancer Based on Engineered Immune Effectors (EIEs)
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: OC-CTLs
Autologous ovarian cancer specific cytotoxic lymphocytes
Biological: OC-CTLs
2 to 4 infusions, once a week, for 1x10^5~4x10^6 CTLs/kg via IV, abdominal cavity or tumor injection each time




Primary Outcome Measures :
  1. Safety of OC-CTLs 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 OC-CTLs in vitro [ Time Frame: 4 weeks ]
    The specificity of OC-CTLs 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

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.


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. Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage II-IV.
  6. Not pregnant, and on appropriate birth control if of childbearing potential.
  7. Initial hematopoietic reconstitution with

    • neutrophils (ANC) ≥ 1,000/mm^3;
    • platelet (PLT) ≥ 100,000/mm^3.
  8. 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.
  9. Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test were negative.

Exclusion Criteria:

  1. Patients with ovarian tumors with low malignant potential (i.e. borderline tumors);
  2. Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).
  3. Previous treatment of adoptive T cell therapy.
  4. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug
  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 infected with HCV (HCV antibody positive), HBV (HBsAg positive), and HIV (HIV 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): NCT03362606


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

Locations
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
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

Responsible Party: Lung-Ji Chang, President, Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT03362606     History of Changes
Other Study ID Numbers: GIMI-IRB-17018
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Ovarian cancer
Cytotoxic lymphocyte
OC-CTL

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type