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History of Changes for Study: NCT03184753
Intervention of IgT Against Ovarian Cancer
Latest version (submitted March 17, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 10, 2017 None (earliest Version on record)
2 November 14, 2017 Study Status
3 January 22, 2018 Outcome Measures, Eligibility, Study Status, Study Identification, Conditions and Study Description
4 February 14, 2018 Study Status
5 September 18, 2019 Study Status
6 March 17, 2020 Recruitment Status and Study Status
Comparison Format:
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Study NCT03184753
Submitted Date:  June 10, 2017 (v1)
Open or close this module Study Identification
Unique Protocol ID: GIMI-IRB-17002
Brief Title: Intervention of IgT Against Ovarian Cancer
Official Title: Interventional Treatment of Ovarian Cancer (OC) With OC Immunogene-modified T Cells (OC-IgT)
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2017
Overall Status: Recruiting
Study Start: May 15, 2017
Primary Completion: December 31, 2018 [Anticipated]
Study Completion: June 30, 2019 [Anticipated]
First Submitted: June 4, 2017
First Submitted that
Met QC Criteria:		 June 10, 2017
First Posted: June 14, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:		 June 10, 2017
Last Update Posted: June 14, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Shenzhen Geno-Immune Medical Institute
Responsible Party: Principal Investigator
Investigator: Lung-Ji Chang
Official Title: Principal Investigator
Affiliation: Shenzhen Geno-Immune Medical Institute
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The primary objectives are to evaluate the safety and efficacy of infusion of autologous ovarian cancer immunogene-modified T cells (OC-IgT cells).
Detailed Description:

Objectives:

Primary study objectives: Administer autologous OC- IgT cells to subjects by IV infusion, to evaluate the safety of the investigational product.

Secondary study objectives: (1) To evaluate the rate of successful autologous OC-IgT cells generation in vitro. (2) To determine the anti-ovarian cancer efficacy of IV-infused autologous OC-IgT cells.
Open or close this module Conditions
Conditions: Ovarian Cancer
Keywords: Autologous
IgT
Ovarian Cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Single arm
OC-IgT cells to treat ovarian cancer.
 Biological: OC-IgT cells
Autologous human OC-IgT cells.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. percentage of adverse effects after OC-IgT cells infusion
[ Time Frame: up to one month ]

To assess the safety of autologous OC-IgT cells infusion. The percentage of patients who have adverse effects will be evaluated by using the NCI CTCAE V4.0 criteria.
Secondary Outcome Measures:
1. Rate of successful OC-IgT generation
[ Time Frame: up to one month ]

The percentage of successful OC-IgT generation, which are derived from subjects or donors and pass the safety test after standard culture procedures, viable for at least one infusion, will be evaluated.
2. Ability of OC-IgT cells for anti-ovarian cancer reactivation prophylaxis-CA125
[ Time Frame: after 1 month from OC-IgT cells infusion until 12 months after infusion ]

measurement of CA125 concentration in blood sample
3. Ability of OC-IgT cells for anti-ovarian cancer reactivation prophylaxis
[ Time Frame: after 1 month from OC-IgT cells infusion until 24 months after infusion ]

Objective response (complete response (CR) + partial response (PR)) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Open or close this module Eligibility
Minimum Age: 20 Years
Maximum Age: 65 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Written, informed consent obtained prior to any study-specific procedures.
  2. Female patients ≥ 20 years.
  3. Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or 2.
  4. Life expectancy ≥ 3 months.
  5. Able to comply with the protocol.
  6. Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage III-IV.

    ·Complete remission after salvage treatment for first recurrence.

  7. Not pregnant, and on appropriate birth control if of childbearing potential.
  8. Adequate bone marrow reserve with
    • absolute neutrophil count (ANC) ≥ 1000/mm3.
    • Platelets ≥100,000/mm3.
  9. Adequate renal and hepatic function with
    • Serum creatinine ≤ 2 x upper limit of normal (ULN).
    • Serum bilirubin ≤ 2 x ULN.
    • aspartate aminotransferase (AST)/ALT ≤ 2 x ULN.
    • Alkaline phosphatase ≤ 5 x ULN.
    • Serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.

Exclusion Criteria:

  1. Patients with:
    • Non-epithelial ovarian cancer.
    • Ovarian tumors with low malignant potential (i.e. borderline tumors).
    • Synchronous primary endometrial carcinoma and ovarian cancer.
  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 CA-125 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:
    • Absolute neutrophil count < 1.0 x 109/L.
    • Platelet count < 100 x 109/L.
    • Hb < 9 g/dL.
  8. Inadequate liver and renal function:
    • 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 (or > 5 x ULN in case of liver metastases or > 10 x ULN in case of bone metastases).
    • 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), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.
Open or close this module Contacts/Locations
Central Contact Person: Lung-Ji Chang, PhD
Telephone: 86-075586725195
Email: c@szgimi.org
Study Officials: Lung-Ji Chang, PhD
Principal Investigator
Shenzhen Geno-Immune Medical Institute
Locations: China, Guangdong
Shenzhen Geno-immune Medical Institute
[Recruiting]
Shenzhen, Guangdong, China, 518000
Contact:Contact: Lung-Ji Chang, PhD 86-075586725195 c@szgimi.org
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services