Engineered Immune Effectors Against Ovarian Cancer

NCT ID: NCT03362606

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-15
• Study Completion Date: 2020-12-31

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.

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OC-CTLs

Autologous ovarian cancer specific cytotoxic lymphocytes

Group Type: EXPERIMENTAL

OC-CTLs

Intervention Type: BIOLOGICAL

2 to 4 infusions, once a week, for 1x10\^5\~4x10\^6 CTLs/kg via IV, abdominal cavity or tumor injection each time

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Geno-Immune Medical Institute

OTHER

Sponsor Role: lead

Responsible Party

Lung-Ji Chang

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lung-Ji Chang, PhD

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Geno-Immune Medical Institute

Qichun Cai, MD

Role: STUDY_DIRECTOR

Jinshazhou Hospital of Guangzhou University of Chinese Medicine

Xun Lai, MD

Role: STUDY_DIRECTOR

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

Locations

Jinshazhou Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Site Status: RECRUITING

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

Site Status: RECRUITING

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

Kunming, Yunnan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lung-Ji Chang, PhD

Role: CONTACT

c@szgimi.org

86-075586725195

Facility Contacts

Qichun Cai, MD

Role: primary

86-13802830754

Lung-Ji Chang, PhD

Role: primary

c@szgimi.org

86-075586725195

Xun Lai, MD

Role: primary

1729112214@qq.com

13577096609

Other Identifiers

GIMI-IRB-17018

Identifier Type: -

Identifier Source: org_study_id