Clinical trial NCT03542669: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Recurrent Ovarian Carcinoma
Platinum-resistant Ovarian Cancer
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Weixiao Biotechnology Development Limited
First posted: 2018-05-31
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: MTD
timeFrame: 1 year
Secondary outcomes:
measure: Changes of the cell immunophenotype
timeFrame: 1 year
measure: Changes of the antinuclear antibody (ANA)
timeFrame: 1 year
measure: Changes of the C-reactive protein (CRP)
timeFrame: 1 year
measure: Changes of the interleukin-6 (IL-6)
timeFrame: 1 year
measure: Changes of the immunoglobulin
timeFrame: 1 year
measure: Objective response rate (ORR)
timeFrame: 3 years
measure: Disease control rate (DCR)
timeFrame: 3 years
measure: Progression Free Survival (PFS)
timeFrame: 3 years
measure: Correlation between OC166-9 antigen expression and efficacy of 6B11-OCIK injection.
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's hospital
Study officials:
affiliation: Peking University People's Hospital
name: Xiaohong Chang
role: PRINCIPAL_INVESTIGATOR
References:
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.