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

Recurrent Ovarian Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03542669
• Other study ID #: 6B11-OCIK-I
• Status: Recruiting
• Phase: Phase 1
• Start date: August 3, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2022
• Source: Peking University People's Hospital
• Contact: Xiaohong Chang
• Phone: 8610-88324472
• Email: changxiaohong[@]pkuph.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Platinum-resistant Ovarian Cancer
• Recurrent Ovarian Carcinoma

Intervention

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.
• Doxorubicin
Subjects will be adminitered 4~6 cycles of chemotherapy (Doxorubicin, 30 mg/m^2 IV on Day 1 of every cycle)

Locations

Country	Name	City	State
China	Peking University People's hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	Beijing Weixiao Biotechnology Development Limited

Country where clinical trial is conducted

China, 

Outcome

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

External Links

•   Preliminary Safety and Potential Effect of 6B11-OCIK Adoptive Cell Therapy Against PlatinumResistant Recurrent or Refractory Ovarian Cancer,Frontiers in immunology,2021,12:707468