Engineered Immune Effectors Against Cervical Cancer
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| ClinicalTrials.gov Identifier: NCT03362619 |
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Recruitment Status : Unknown
Verified September 2019 by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute.
Recruitment status was: Recruiting
First Posted : December 5, 2017
Last Update Posted : September 19, 2019
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Sponsor:
Shenzhen Geno-Immune Medical Institute
Information provided by (Responsible Party):
Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | November 20, 2017 | |||||||||
| First Posted Date ICMJE | December 5, 2017 | |||||||||
| Last Update Posted Date | September 19, 2019 | |||||||||
| Actual Study Start Date ICMJE | November 15, 2017 | |||||||||
| Actual Primary Completion Date | January 31, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Safety of CC-EIEs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events [ Time Frame: 6 months ] Physiological parameter (measuring cytokine response, fever, symptoms)
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| Original Primary Outcome Measures ICMJE |
Safety of CC-CTLs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events [ Time Frame: 6 months ] Physiological parameter (measuring cytokine response, fever, symptoms)
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| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Engineered Immune Effectors Against Cervical Cancer | |||||||||
| Official Title ICMJE | Innovative Treatment of Cervical Cancer Using Engineered Antigen-specific Immune Effectors (EIEs) | |||||||||
| Brief Summary | The primary objective of this study is to evaluate the safety of cervical cancer specific engineered immune effectors (CC-EIEs). The secondary objectives are to evaluate the rate of successful CC-EIE generation in vitro and determine the anti-CC efficacy. | |||||||||
| Detailed Description | Cervical cancer (CC) is a cancer arising from the cervix. Human papillomavirus (HPV) infection causes more than 90% of the cases. Other risk factors include smoking, a weak immune system, birth control pills, starting sex at a young age, and having many sexual partners, but these are less important. Worldwide, CC is both the fourth-most common cause of cancer and the fourth-most common cause of death from cancer in women. The treatment of CC consists of surgical intervention, radiation, chemotherapy and immunotherapy. Adoptive immunotherapy with cytotoxic T lymphocytes reactive with specific viral antigens has proven to be effective. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of CC-specific engineered immune effectors including cytotoxic T lymphocytes in patients. |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Cervical Cancer | |||||||||
| Intervention ICMJE | Biological: CC-EIEs
2 to 4 infusions, once a week, for 1x10^5~1x10^7 CTLs/kg via IV, abdominal cavity or intratumoral injection each time
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| Study Arms ICMJE | Experimental: CC-EIEs
Autologous cervical cancer specific engineered immune effectors (EIEs)
Intervention: Biological: CC-EIEs
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Unknown status | |||||||||
| Estimated Enrollment ICMJE |
20 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | December 2020 | |||||||||
| Actual Primary Completion Date | January 31, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 10 Years to 80 Years (Child, Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | China | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT03362619 | |||||||||
| Other Study ID Numbers ICMJE | GIMI-IRB-17019 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Current Responsible Party | Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor ICMJE | Shenzhen Geno-Immune Medical Institute | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Shenzhen Geno-Immune Medical Institute | |||||||||
| Verification Date | September 2019 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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