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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03393962
Other study ID # GIMI-IRB-17024
Secondary ID
Status Suspended
Phase Phase 1/Phase 2
First received
Last updated
Start date December 1, 2017
Est. completion date December 2020

Study information

Verified date July 2018
Source Shenzhen Geno-Immune Medical Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Suspended
Enrollment 20
Est. completion date December 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender Female
Age group 10 Years to 80 Years
Eligibility 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 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 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. Prior treatment of any adoptive T cell therapy.

4. Current or recent treatment (within the 14-day period prior to Day 0) with any immune suppressive 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

10. Subject infected with HCV (HCV antibody positive), or HIV (HIV antibody positive),Treponema pallidum antibody positive or TB culture positive.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Jinshazhou Hospital of Guangzhou University of Chinese Medicine Guangzhou Guangdong
China Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center Kunming Yunnan
China Shenzhen Geno-immune Medical Institute Shenzhen Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Shenzhen Geno-Immune Medical Institute

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months
Secondary Expansion of OC-EIEs The increased fold of specificity of OC-EIEs, will be analyzed by enzyme-linked immunospot assay (ELISPOT) 8 weeks.
Secondary percentage of complete response Objective response will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. 1 year
Secondary percentage of partial response Objective response will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. 1 year
Secondary percentage of stable disease Objective response will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. 1 year
Secondary percentage of progressive disease Objective response will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. 1 year
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