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Genetically Modified T Cells Against Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

OC-IgT cells

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Autologous, IgT, Ovarian Cancer, CART

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Written, informed consent obtained prior to any study-specific procedures.
Female patients ≥ 20 years.
Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or 2.
Life expectancy ≥ 3 months.
Able to comply with the protocol.
Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage III-IV.
- Complete remission after salvage treatment for first recurrence.
Not pregnant, and on appropriate birth control if of childbearing potential.
Adequate bone marrow reserve with ·absolute neutrophil count (ANC) ≥ 1000/mm3.
·Platelets ≥100,000/mm3.
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).

Previous experience of gene-engineered T cell therapy 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 HIV (HIV antibody positive), Treponema pallidum antibody positive or TB culture positive.

Sites / Locations

Shenzhen Geno-immune Medical InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

OC-IgT cells to treat ovarian cancer.

Outcomes

Primary Outcome Measures

percentage of adverse effects after OC-IgT cells injection

To assess the safety of autologous OC-IgT cells in vivo. The percentage of patients who have adverse effects will be evaluated by using the NCI CTCAE V4.0 criteria.

Secondary Outcome Measures

Rate of successful OC-IgT generation

The percentage of successful OC-IgT generation, which are derived from subjects and pass the safety test after standard culture procedures, viable for at least one prepatation, will be evaluated.

Ability of OC-IgT cells to induce anti-ovarian cancer reaction

measurement of CA125 concentration in blood sample

Ability of OC-IgT cells for anti-ovarian cancer reaction

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.

Full Information

NCT ID

NCT03184753

First Posted

June 4, 2017

Last Updated

March 17, 2020

Sponsor

Shenzhen Geno-Immune Medical Institute

1. Study Identification

Unique Protocol Identification Number

NCT03184753

Brief Title

Genetically Modified T Cells Against Ovarian Cancer

Official Title

Innovative Treatment of Ovarian Cancer Based on Immunogene-modified T Cells (IgT)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 15, 2017 (Actual)

Primary Completion Date

March 31, 2020 (Anticipated)

Study Completion Date

December 31, 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

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

Ovarian cancer (OC) is a cancer that forms in or on 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 it is the seventh-most common cancer and the eighth-most common cause of death from cancer. Treatment for OC consists of surgery, chemotherapy, radiotherapy and sometimes, novel immunotherapies. The best treatment options depend 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 reactive with specific antigens has proven to be effective. Novel chimeric antigen receptor gene modified T cell (CART) based immunotherapy has demonstrated great successes in B cell malignancies. Here, the study aim is to evaluate the safety and efficacy of genetically engineered OC-specific and immune modulatory T cells in patients. The primary study objectives are to evaluate the safety of the investigational product, autologous OC-IgT cells, to subjects by IV and intratumoral injection. The secondary study objectives are (1) to evaluate the success rate of generating autologous OC-IgT cells in vitro, and (2) to determine the anti-OC efficacy of the OC-IgT cells.

6. Conditions and Keywords

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

Ovarian Cancer

Keywords

Autologous, IgT, Ovarian Cancer, CART

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

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single arm

Arm Type

Experimental

Arm Description

OC-IgT cells to treat ovarian cancer.

Intervention Type

Biological

Intervention Name(s)

OC-IgT cells

Intervention Description

Autologous human OC-IgT cells.

Primary Outcome Measure Information:

Title

percentage of adverse effects after OC-IgT cells injection

Description

To assess the safety of autologous OC-IgT cells in vivo. The percentage of patients who have adverse effects will be evaluated by using the NCI CTCAE V4.0 criteria.

Time Frame

up to one month

Secondary Outcome Measure Information:

Title

Rate of successful OC-IgT generation

Description

The percentage of successful OC-IgT generation, which are derived from subjects and pass the safety test after standard culture procedures, viable for at least one prepatation, will be evaluated.

Time Frame

up to one month

Title

Ability of OC-IgT cells to induce anti-ovarian cancer reaction

Description

measurement of CA125 concentration in blood sample

Time Frame

after 1 month from OC-IgT cells infusion until 12 months after infusion

Title

Ability of OC-IgT cells for anti-ovarian cancer reaction

Description

Time Frame

after 1 month from OC-IgT cell infusion until 24 months after infusion

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written, informed consent obtained prior to any study-specific procedures. Female patients ≥ 20 years. Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or 2. Life expectancy ≥ 3 months. Able to comply with the protocol. Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage III-IV. Complete remission after salvage treatment for first recurrence. Not pregnant, and on appropriate birth control if of childbearing potential. Adequate bone marrow reserve with ·absolute neutrophil count (ANC) ≥ 1000/mm3. ·Platelets ≥100,000/mm3. 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). Previous experience of gene-engineered T cell therapy 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 HIV (HIV antibody positive), Treponema pallidum antibody positive or TB culture positive.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lung-Ji Chang, PhD

Phone

86-075586725195

c@szgimi.org

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

Facility Information:

Facility Name

Shenzhen Geno-immune Medical Institute

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lung-Ji Chang, PhD

Phone

86-075586725195

c@szgimi.org

12. IPD Sharing Statement

Plan to Share IPD

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Genetically Modified T Cells Against Ovarian Cancer

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