Back to resultsStudy of 6b11-OCIK Injection Treatment in Patients With Recurrent Drug-resistant Ovarian Cancer
Primary Purpose
Recurrent Ovarian Carcinoma, Platinum-resistant Ovarian Cancer
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
6B11-OCIK Injection
Doxorubicin
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Ovarian Carcinoma
Eligibility Criteria
Inclusion criteria:
- 18-70 years old patients.
- Diagnosed as Ovarian Cancer, who had relapsed after initial treatment; Relapse after drug resistance: clinical remission after early chemotherapy, but progression or relapse within 6 months after chemotherapy,or achieve no response after early chemotherapy.
- Administered with Doxorubicin.
Exclusion criteria:
- Symptomatic and uncontrolled Brain metastasis or pia meningeal metastasis; Patients with spinal cord compression; Symptoms related to central nervous system lesions or symptoms indicating disease progression;
- Corticosteroid drugs (or analogues) or drugs effecting the immune system were administered before infusion in 4 weeks.
- Patients with interstitial lung disease or interstitial pneumonia, including clinically significant radiation pneumonia;
- Women with positive serum pregnancy test or lactation;
Sites / Locations
- Peking University People's hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
6B11-OCIK injection
Arm Description
Outcomes
Primary Outcome Measures
MTD
Determine the maximum tolerable dose (MTD) of 6B11-OCIK injection in the treatment of patients with ovarian cancer base on the AE, SAE and laboratory examination.
Secondary Outcome Measures
Changes of the cell immunophenotype
Changes in the concentrations of the cell immunophenotype (CD3+, CD3+CD4+, CD3+CD8+, CD3-CD56+, CD3-CD19+) in peripheral blood after 6B11-OCIK injection from baseline.
Changes of the antinuclear antibody (ANA)
Changes in the concentrations of the antinuclear antibody (ANA) in peripheral blood after 6B11-OCIK injection from baseline.
Changes of the C-reactive protein (CRP)
Changes in the concentrations of the C-reactive protein (CRP) in peripheral blood after 6B11-OCIK injection from baseline.
Changes of the interleukin-6 (IL-6)
Changes in the concentrations of the interleukin-6 (IL-6) in peripheral blood after 6B11-OCIK injection from baseline.
Changes of the immunoglobulin
Changes in the concentrations of the immunoglobulin in peripheral blood after 6B11-OCIK injection from baseline.
Objective response rate (ORR)
Percentage of patients who achieved CR and PR after treatment.
Disease control rate (DCR)
Percentage of evaluable patients who achieved CR, PR and SD after treatment.
Progression Free Survival (PFS)
The period from the first infusion of 6B11-OCIK to first PD or death from any cause.
Correlation between OC166-9 antigen expression and efficacy of 6B11-OCIK injection.
OC166-9 antigen expression and efficacy of 6B11-OCIK
Full Information
NCT ID
NCT03542669
First Posted
May 20, 2018
Last Updated
February 11, 2022
Sponsor
Peking University People's Hospital
Collaborators
Beijing Weixiao Biotechnology Development Limited
1. Study Identification
Unique Protocol Identification Number
NCT03542669
Brief Title
Study of 6b11-OCIK Injection Treatment in Patients With Recurrent Drug-resistant Ovarian Cancer
Official Title
A Phase I Study of Autologous Killer Cell Injection Induced by Dendritic Dells Loaded With 6B11 Anti-idiotype Minibody (6b11 - OCIK Injection) Treatment in Patients With Recurrent Drug-resistant Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2018 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
Collaborators
Beijing Weixiao Biotechnology Development Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an open, single-arm, phase I clinical trial to evaluate safety and efficacy and of 6b11-OCIK injection in the treatment of recurrent drug-resistant ovarian cancer
Detailed Description
This is a phase I clinical trial of cytotoxic T cell injection induced by dendritic cells loaded with 6B11 anti-idiotype minibody (6b11-OCIK injection) for recurrent drug-resistant ovarian cancer. Main purpose of this research is to determine the maximum tolerable dose (MTD) of 6B11-OCIK injection in the treatment of patients with ovarian cancer. Moreover, secondary purpose is to evaluate the effect of 6B11-OCIK injection on the immune system of patients, the efficacy of autologous 6B11-OCIK injection in the treatment of patients with ovarian cancer obtain and the correlation between OC166-9 antigen expression and efficacy of 6B11-OCIK injection. Thirdly, exploratory purpose is to evaluate the effect of 6B11-OCIK injection on laboratory examination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Ovarian Carcinoma, Platinum-resistant Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
6B11-OCIK injection
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
6B11-OCIK Injection
Intervention Description
Two infusions of 6B11-OCIK will be performed at each chemotherapy cycle (Day 3 an Day 7) during the first three cycles, while PBMC will be collected before each cycle (Day -12) during the first three cycles.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Subjects will be adminitered 4~6 cycles of chemotherapy (Doxorubicin, 30 mg/m^2 IV on Day 1 of every cycle)
Primary Outcome Measure Information:
Title
MTD
Description
Determine the maximum tolerable dose (MTD) of 6B11-OCIK injection in the treatment of patients with ovarian cancer base on the AE, SAE and laboratory examination.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Changes of the cell immunophenotype
Description
Changes in the concentrations of the cell immunophenotype (CD3+, CD3+CD4+, CD3+CD8+, CD3-CD56+, CD3-CD19+) in peripheral blood after 6B11-OCIK injection from baseline.
Time Frame
1 year
Title
Changes of the antinuclear antibody (ANA)
Description
Changes in the concentrations of the antinuclear antibody (ANA) in peripheral blood after 6B11-OCIK injection from baseline.
Time Frame
1 year
Title
Changes of the C-reactive protein (CRP)
Description
Changes in the concentrations of the C-reactive protein (CRP) in peripheral blood after 6B11-OCIK injection from baseline.
Time Frame
1 year
Title
Changes of the interleukin-6 (IL-6)
Description
Changes in the concentrations of the interleukin-6 (IL-6) in peripheral blood after 6B11-OCIK injection from baseline.
Time Frame
1 year
Title
Changes of the immunoglobulin
Description
Changes in the concentrations of the immunoglobulin in peripheral blood after 6B11-OCIK injection from baseline.
Time Frame
1 year
Title
Objective response rate (ORR)
Description
Percentage of patients who achieved CR and PR after treatment.
Time Frame
3 years
Title
Disease control rate (DCR)
Description
Percentage of evaluable patients who achieved CR, PR and SD after treatment.
Time Frame
3 years
Title
Progression Free Survival (PFS)
Description
The period from the first infusion of 6B11-OCIK to first PD or death from any cause.
Time Frame
3 years
Title
Correlation between OC166-9 antigen expression and efficacy of 6B11-OCIK injection.
Description
OC166-9 antigen expression and efficacy of 6B11-OCIK
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
18-70 years old patients.
Diagnosed as Ovarian Cancer, who had relapsed after initial treatment; Relapse after drug resistance: clinical remission after early chemotherapy, but progression or relapse within 6 months after chemotherapy,or achieve no response after early chemotherapy.
Administered with Doxorubicin.
Exclusion criteria:
Symptomatic and uncontrolled Brain metastasis or pia meningeal metastasis; Patients with spinal cord compression; Symptoms related to central nervous system lesions or symptoms indicating disease progression;
Corticosteroid drugs (or analogues) or drugs effecting the immune system were administered before infusion in 4 weeks.
Patients with interstitial lung disease or interstitial pneumonia, including clinically significant radiation pneumonia;
Women with positive serum pregnancy test or lactation;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohong Chang
Phone
8610-88324472
Email
changxiaohong@pkuph.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
hongyan Cheng
Phone
8610-88324472
Email
chyan7581@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaohong Chang
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University People's hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
8610-88324472
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34408750
Citation
Cheng H, Ma R, Wang S, Wang Y, Li Y, Tang Z, Dou S, Wang Y, Zhu H, Ye X, Zhang T, Zhang Y, Li S, Zhao Y, Li Y, Cui H, Chang X. Preliminary Safety and Potential Effect of 6B11-OCIK Adoptive Cell Therapy Against Platinum-Resistant Recurrent or Refractory Ovarian Cancer. Front Immunol. 2021 Aug 2;12:707468. doi: 10.3389/fimmu.2021.707468. eCollection 2021.
Results Reference
derived
Links:
URL
http://doi.org/10.3389/fimmu.2021.707468
Description
Preliminary Safety and Potential Effect of 6B11-OCIK Adoptive Cell Therapy Against PlatinumResistant Recurrent or Refractory Ovarian Cancer,Frontiers in immunology,2021,12:707468
Learn more about this trial
Study of 6b11-OCIK Injection Treatment in Patients With Recurrent Drug-resistant Ovarian Cancer
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