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

Phase 1

• Conditions: Recurrent Ovarian Carcinoma; Platinum-resistant Ovarian Cancer
• Interventions: Drug: 6B11-OCIK Injection; Drug: Doxorubicin

• Registration Number: NCT03542669
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study First Submitted: 2018-05-20
• Study First Submitted QC: 2018-05-20
• Study First Posted: 2018-05-31
• Study Start: 2018-08-03
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-03-02
• Primary Completion: 2022-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
6B11-OCIK injection	Doxorubicin	-
6B11-OCIK injection	6B11-OCIK Injection	-

Primary Outcome Measures

Name	Time	Method
MTD	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.

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	3 years	Percentage of patients who achieved CR and PR after treatment.
Changes of the cell immunophenotype	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.
Changes of the C-reactive protein (CRP)	1 year	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)	1 year	Changes in the concentrations of the interleukin-6 (IL-6) in peripheral blood after 6B11-OCIK injection from baseline.
Changes of the immunoglobulin	1 year	Changes in the concentrations of the immunoglobulin in peripheral blood after 6B11-OCIK injection from baseline.
Changes of the antinuclear antibody (ANA)	1 year	Changes in the concentrations of the antinuclear antibody (ANA) in peripheral blood after 6B11-OCIK injection from baseline.
Disease control rate (DCR)	3 years	Percentage of evaluable patients who achieved CR, PR and SD after treatment.
Progression Free Survival (PFS)	3 years	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.	1 year	OC166-9 antigen expression and efficacy of 6B11-OCIK

Trial Locations

Locations (1)

Peking University People's hospital; 🇨🇳 Beijing, China