NCT03542669

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Ovarian Carcinoma
• Platinum-resistant Ovarian Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-08-03
• Primary completion: 2022-12-30
• Completion: 2023-12-30
• First posted: 2018-05-31
• Last updated: 2022-03-02

Locations

1 site across 1 country: China