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| Name | Class |
|---|---|
| Beijing Weixiao Biotechnology Development Limited | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6B11-OCIK injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6B11-OCIK Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes of the antinuclear antibody (ANA) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohong Chang | Contact | 8610-88324472 | changxiaohong@pkuph.edu.cn | |
| hongyan Cheng | Contact | 8610-88324472 | chyan7581@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaohong Chang | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's hospital | Recruiting | Beijing | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34408750 | Derived | 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. |
| Label | URL |
|---|---|
| Preliminary Safety and Potential Effect of 6B11-OCIK Adoptive Cell Therapy Against PlatinumResistant Recurrent or Refractory Ovarian Cancer,Frontiers in immunology,2021,12:707468 | View source |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Doxorubicin | Drug | Subjects will be adminitered 4~6 cycles of chemotherapy (Doxorubicin, 30 mg/m^2 IV on Day 1 of every cycle) |
|
Changes in the concentrations of the antinuclear antibody (ANA) in peripheral blood after 6B11-OCIK injection from baseline. |
| 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. | 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. | 1 year |
| Changes of the immunoglobulin | Changes in the concentrations of the immunoglobulin in peripheral blood after 6B11-OCIK injection from baseline. | 1 year |
| Objective response rate (ORR) | Percentage of patients who achieved CR and PR after treatment. | 3 years |
| Disease control rate (DCR) | Percentage of evaluable patients who achieved CR, PR and SD after treatment. | 3 years |
| Progression Free Survival (PFS) | The period from the first infusion of 6B11-OCIK to first PD or death from any cause. | 3 years |
| Correlation between OC166-9 antigen expression and efficacy of 6B11-OCIK injection. | OC166-9 antigen expression and efficacy of 6B11-OCIK | 1 year |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |