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
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
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.
Subjects will be adminitered 4\~6 cycles of chemotherapy (Doxorubicin, 30 mg/m\^2 IV on Day 1 of every cycle)
Peking University People's hospital
Beijing, China
RECRUITINGMTD
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
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.
Time frame: 1 year
Changes of the antinuclear antibody (ANA)
Changes in the concentrations of the antinuclear antibody (ANA) in peripheral blood after 6B11-OCIK injection from baseline.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
Changes of the immunoglobulin
Changes in the concentrations of the immunoglobulin in peripheral blood after 6B11-OCIK injection from baseline.
Time frame: 1 year
Objective response rate (ORR)
Percentage of patients who achieved CR and PR after treatment.
Time frame: 3 years
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Disease control rate (DCR)
Percentage of evaluable patients who achieved CR, PR and SD after treatment.
Time frame: 3 years
Progression Free Survival (PFS)
The period from the first infusion of 6B11-OCIK to first PD or death from any cause.
Time frame: 3 years
Correlation between OC166-9 antigen expression and efficacy of 6B11-OCIK injection.
OC166-9 antigen expression and efficacy of 6B11-OCIK
Time frame: 1 year