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Intervention of Ovarian Cancer With Antigen-specific Engineered Immune Effectors

Primary Purpose

Ovarian Cancer

Status

Suspended

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

OC-EIEs

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian cancer, Cytotoxic lymphocyte, Cancer specific antigen

Eligibility Criteria

10 Years - 80 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Written, informed consent obtained prior to any study-specific procedures.
Age older than 10 years.
Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
Expected survival ≥ 12 weeks.
Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage II-IV.
Not pregnant, and on appropriate birth control of childbearing potential.
Initial hematopoietic reconstitution with
- neutrophils (ANC) ≥ 1,000/mm^3;
- platelet (PLT) ≥ 100,000/mm^3.
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.
Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) test negative.

Exclusion Criteria:

Patients with ovarian tumors with low malignant potential (i.e. borderline tumors);
Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).
Prior treatment of any adoptive T cell therapy.
Current or recent treatment (within the 14-day period prior to Day 0) with any immune suppressive drug
Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).
Pregnant or lactating females.
Inadequate bone marrow function with
- absolute neutrophil count < 1,000/mm^3;
- platelet count < 100,000/mm^3;
- Hb < 9 g/dL.
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.
Serious active infection requiring i.v. antibiotics
Subject infected with HCV (HCV antibody positive), or HIV (HIV antibody positive),Treponema pallidum antibody positive or TB culture positive.

Sites / Locations

Jinshazhou Hospital of Guangzhou University of Chinese Medicine
Shenzhen Geno-immune Medical Institute
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OC-EIEs

Arm Description

Autologous ovarian cancer antigen-specific cytotoxic lymphocytes

Outcomes

Primary Outcome Measures

Safety of OC-EIEs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events

percentage of patients with grade 3 or above adverse effect

Secondary Outcome Measures

Expansion of OC-EIEs

The increased fold of specificity of OC-EIEs, will be analyzed by enzyme-linked immunospot assay (ELISPOT)

percentage of complete response

Objective response will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

percentage of partial response

Objective response will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

percentage of stable disease

Objective response will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

percentage of progressive disease

Objective response will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Full Information

NCT ID

NCT03393962

First Posted

December 28, 2017

Last Updated

July 30, 2018

Sponsor

Shenzhen Geno-Immune Medical Institute

1. Study Identification

Unique Protocol Identification Number

NCT03393962

Brief Title

Intervention of Ovarian Cancer With Antigen-specific Engineered Immune Effectors

Official Title

Interventional Treatment of Ovarian Cancer With Cancer Antigen-specific Engineered Immune Effector T Lymphocytes (OC-EIEs)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Suspended

Why Stopped

combine with another trial

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

January 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shenzhen Geno-Immune Medical Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a single-arm, open-label, phase I/II trial to evaluate the safety and efficacy of ovarian cancer-specific, engineered immune effectors (OC-EIEs) in women.

Detailed Description

Ovarian cancer (OC) is a cancer that is derived from an ovary. The majority of OC arises from the epithelium (outer lining) of the ovary. In 2015, OC was found in 1.2 million women and resulted in 161,100 deaths worldwide. Among women, OC is the seventh-most common cancer and the eighth-most common cause of cancer death. Treatment for OC consists of surgery, chemotherapy, immunotherapy and radiotherapy. The kind of treatment depends on many factors, including the type of OC, its stage and grade, as well as the general health of the patient. Adoptive immunotherapy with cytotoxic T lymphocytes (CTLs) reactive with tumor antigens has proven to be effective against many types of cancer. OC has been shown to be highly immunogenic and therefore may respond well to innovative antigen-specific immunotherapy. Here, through cancer antigen screening and careful target antigen evaluation, the investigation aims to evaluate the safety and efficacy of multiple infusions of OC antigen-specific, engineered immune effectors (EIEs) in patients with OC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer

Keywords

Ovarian cancer, Cytotoxic lymphocyte, Cancer specific antigen

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

OC-EIEs

Arm Type

Experimental

Arm Description

Autologous ovarian cancer antigen-specific cytotoxic lymphocytes

Intervention Type

Biological

Intervention Name(s)

OC-EIEs

Intervention Description

2 to 4 infusions, once a week, 0.1~4x10^6 CTLs/kg; injection via IV, abdominal cavity or intrastumoral.

Primary Outcome Measure Information:

Title

Safety of OC-EIEs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events

Description

percentage of patients with grade 3 or above adverse effect

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Expansion of OC-EIEs

Description

The increased fold of specificity of OC-EIEs, will be analyzed by enzyme-linked immunospot assay (ELISPOT)

Time Frame

8 weeks.

Title

percentage of complete response

Description

Objective response will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Time Frame

1 year

Title

percentage of partial response

Description

Objective response will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Time Frame

1 year

Title

percentage of stable disease

Description

Objective response will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Time Frame

1 year

Title

percentage of progressive disease

Description

Objective response will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written, informed consent obtained prior to any study-specific procedures. Age older than 10 years. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. Expected survival ≥ 12 weeks. Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage II-IV. Not pregnant, and on appropriate birth control of childbearing potential. Initial hematopoietic reconstitution with neutrophils (ANC) ≥ 1,000/mm^3; platelet (PLT) ≥ 100,000/mm^3. 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. Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) test negative. Exclusion Criteria: Patients with ovarian tumors with low malignant potential (i.e. borderline tumors); Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment). Prior treatment of any adoptive T cell therapy. Current or recent treatment (within the 14-day period prior to Day 0) with any immune suppressive drug Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations). Pregnant or lactating females. Inadequate bone marrow function with absolute neutrophil count < 1,000/mm^3; platelet count < 100,000/mm^3; Hb < 9 g/dL. 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. Serious active infection requiring i.v. antibiotics Subject infected with HCV (HCV antibody positive), or HIV (HIV antibody positive),Treponema pallidum antibody positive or TB culture positive.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lung-Ji Chang, PhD

Organizational Affiliation

Shenzhen Geno-Immune Medical Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Qichun Cai, MD

Organizational Affiliation

Jinshazhou Hospital of Guangzhou University of Chinese Medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Xun Lai, MD

Organizational Affiliation

Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center

Official's Role

Study Director

Facility Information:

Facility Name

Jinshazhou Hospital of Guangzhou University of Chinese Medicine

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510415

Country

China

Facility Name

Shenzhen Geno-immune Medical Institute

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518000

Country

China

Facility Name

Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center

City

Kunming

State/Province

Yunnan

ZIP/Postal Code

650000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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Intervention of Ovarian Cancer With Antigen-specific Engineered Immune Effectors

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