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Engineered Immune Effectors Against Cervical Cancer

Primary Purpose

Cervical Cancer

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

CC-EIEs

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Cervical cancer, Cytotoxic lymphocyte, CC-CTL

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.
Not pregnant, and on appropriate birth control if of childbearing potential.
Evidence of high-risk HPV infection.
Stage III-IV or recurrent cervical cancer.
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
- cervical benign lesions: cervical columnar epithelium ectopic, cervical polyps, cervical endometriosis and cervical tuberculous ulcers;
- cervical benign tumors: cervical submucous myoma, cervical cancer, cervical papilloma.
Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).
Previous exposure to mouse SCC antibody.
Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
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 at during screening.
Subject actively 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.

Sites / Locations

Jinshazhou Hospital of Guangzhou University of Chinese MedicineRecruiting
Shenzhen Geno-immune Medical InstituteRecruiting
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CC-EIEs

Arm Description

Autologous cervical cancer specific engineered immune effectors (EIEs)

Outcomes

Primary Outcome Measures

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

Physiological parameter (measuring cytokine response, fever, symptoms)

Secondary Outcome Measures

Functional analyses of CC-EIEs in vitro

The specificity of CC-EIEs in vitro will be analysed by enzyme-linked immunospot assay (ELISPOT).

Anti-tumor effects

Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Full Information

NCT ID

NCT03362619

First Posted

November 20, 2017

Last Updated

September 18, 2019

Sponsor

Shenzhen Geno-Immune Medical Institute

1. Study Identification

Unique Protocol Identification Number

NCT03362619

Brief Title

Engineered Immune Effectors Against Cervical Cancer

Official Title

Innovative Treatment of Cervical Cancer Using Engineered Antigen-specific Immune Effectors (EIEs)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 15, 2017 (Actual)

Primary Completion Date

January 31, 2019 (Actual)

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

The primary objective of this study is to evaluate the safety of cervical cancer specific engineered immune effectors (CC-EIEs). The secondary objectives are to evaluate the rate of successful CC-EIE generation in vitro and determine the anti-CC efficacy.

Detailed Description

Cervical cancer (CC) is a cancer arising from the cervix. Human papillomavirus (HPV) infection causes more than 90% of the cases. Other risk factors include smoking, a weak immune system, birth control pills, starting sex at a young age, and having many sexual partners, but these are less important. Worldwide, CC is both the fourth-most common cause of cancer and the fourth-most common cause of death from cancer in women. The treatment of CC consists of surgical intervention, radiation, chemotherapy and immunotherapy. Adoptive immunotherapy with cytotoxic T lymphocytes reactive with specific viral antigens has proven to be effective. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of CC-specific engineered immune effectors including cytotoxic T lymphocytes in patients.

6. Conditions and Keywords

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

Cervical Cancer

Keywords

Cervical cancer, Cytotoxic lymphocyte, CC-CTL

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

CC-EIEs

Arm Type

Experimental

Arm Description

Autologous cervical cancer specific engineered immune effectors (EIEs)

Intervention Type

Biological

Intervention Name(s)

CC-EIEs

Intervention Description

2 to 4 infusions, once a week, for 1x10^5~1x10^7 CTLs/kg via IV, abdominal cavity or intratumoral injection each time

Primary Outcome Measure Information:

Title

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

Description

Physiological parameter (measuring cytokine response, fever, symptoms)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Functional analyses of CC-EIEs in vitro

Description

The specificity of CC-EIEs in vitro will be analysed by enzyme-linked immunospot assay (ELISPOT).

Time Frame

4 weeks

Title

Anti-tumor effects

Description

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. Not pregnant, and on appropriate birth control if of childbearing potential. Evidence of high-risk HPV infection. Stage III-IV or recurrent cervical cancer. 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 cervical benign lesions: cervical columnar epithelium ectopic, cervical polyps, cervical endometriosis and cervical tuberculous ulcers; cervical benign tumors: cervical submucous myoma, cervical cancer, cervical papilloma. Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment). Previous exposure to mouse SCC antibody. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study. 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 at during screening. Subject actively 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.

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

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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qichun Cai, MD

Phone

86-13802830754

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

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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xun Lai, MD

Phone

13577096609

1729112214@qq.com

12. IPD Sharing Statement

Plan to Share IPD

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Engineered Immune Effectors Against Cervical Cancer

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