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Status unknownNCT03542669Updated Mar 2, 2022

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

A Phase 1 interventional study of 6B11-OCIK Injection and Doxorubicin in Recurrent Ovarian Carcinoma and Platinum-resistant Ovarian Cancer, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by Peking University People's Hospital · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Female
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Study 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

Read the 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.

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Conditions studied

  • Recurrent Ovarian Carcinoma
  • Platinum-resistant Ovarian Cancer
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 9 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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;
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (estimated)

Study arms

  • Experimental
    6B11-OCIK injection

    Drug: 6B11-OCIK Injection · Drug: Doxorubicin

Interventions

  • Drug6B11-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.

  • DrugDoxorubicin

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Changes of the immunoglobulin

    Changes in the concentrations of the immunoglobulin in peripheral blood after 6B11-OCIK injection from baseline.

    Time frame: 1 year

  6. Objective response rate (ORR)

    Percentage of patients who achieved CR and PR after treatment.

    Time frame: 3 years

  7. Disease control rate (DCR)

    Percentage of evaluable patients who achieved CR, PR and SD after treatment.

    Time frame: 3 years

  8. 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

  9. 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

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Study locations

1 of 1 sites recruiting
  • Peking University People's hospital
    Beijing, 100044, China
    • · Contact · 8610-88324472
    Recruiting
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References and documents

Publications

  • 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. PubMed 34408750 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03542669
Lead sponsor
Peking University People's Hospital
Collaborators
Beijing Weixiao Biotechnology Development Limited
Responsible party
Changxiaohong (Director of Gynaecologic Oncology Center, Peking University People's Hospital) — Principal investigator
First posted
May 31, 2018
Start date
Aug 3, 2018
Primary completion
Dec 30, 2022 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Mar 2, 2022

Study contacts

Xiaohong Chang
Contact
changxiaohong@pkuph.edu.cn
8610-88324472
hongyan Cheng
Contact
chyan7581@sina.com
8610-88324472
Xiaohong Chang
principal investigator · Peking University People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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