Study of 6b11-OCIK Injection Treatment in Patients With Recurrent Drug-resistant Ovarian Cancer

February 11, 2022 updated by: Changxiaohong, Peking University People's Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Phone Number: 8610-88324472

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria:

  1. 18-70 years old patients.
  2. 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.
  3. Administered with Doxorubicin.

Exclusion criteria:

  1. 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;
  2. Corticosteroid drugs (or analogues) or drugs effecting the immune system were administered before infusion in 4 weeks.
  3. Patients with interstitial lung disease or interstitial pneumonia, including clinically significant radiation pneumonia;
  4. Women with positive serum pregnancy test or lactation;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 6B11-OCIK injection
Drug: 6B11-OCIK Injection
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.
Drug: Doxorubicin
Subjects will be adminitered 4~6 cycles of chemotherapy (Doxorubicin, 30 mg/m^2 IV on Day 1 of every cycle)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MTD
Time Frame: 1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of the cell immunophenotype
Time Frame: 1 year
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.
1 year
Changes of the antinuclear antibody (ANA)
Time Frame: 1 year
Changes in the concentrations of the antinuclear antibody (ANA) in peripheral blood after 6B11-OCIK injection from baseline.
1 year
Changes of the C-reactive protein (CRP)
Time Frame: 1 year
Changes in the concentrations of the C-reactive protein (CRP) in peripheral blood after 6B11-OCIK injection from baseline.
1 year
Changes of the interleukin-6 (IL-6)
Time Frame: 1 year
Changes in the concentrations of the interleukin-6 (IL-6) in peripheral blood after 6B11-OCIK injection from baseline.
1 year
Changes of the immunoglobulin
Time Frame: 1 year
Changes in the concentrations of the immunoglobulin in peripheral blood after 6B11-OCIK injection from baseline.
1 year
Objective response rate (ORR)
Time Frame: 3 years
Percentage of patients who achieved CR and PR after treatment.
3 years
Disease control rate (DCR)
Time Frame: 3 years
Percentage of evaluable patients who achieved CR, PR and SD after treatment.
3 years
Progression Free Survival (PFS)
Time Frame: 3 years
The period from the first infusion of 6B11-OCIK to first PD or death from any cause.
3 years
Correlation between OC166-9 antigen expression and efficacy of 6B11-OCIK injection.
Time Frame: 1 year
OC166-9 antigen expression and efficacy of 6B11-OCIK
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

Beijing Weixiao Biotechnology Development Limited

Investigators

  • Principal Investigator: Xiaohong Chang, Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 3, 2018

Primary Completion (ANTICIPATED)

December 30, 2022

Study Completion (ANTICIPATED)

December 30, 2023

Study Registration Dates

First Submitted

May 20, 2018

First Submitted That Met QC Criteria

May 20, 2018

First Posted (ACTUAL)

May 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 11, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6B11-OCIK-I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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