HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of HPV
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|ClinicalTrials.gov Identifier: NCT03351855|
Recruitment Status : Unknown
Verified September 2019 by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute.
Recruitment status was: Recruiting
First Posted : November 24, 2017
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Human Papilloma Virus||Biological: HPV-CTLs||Phase 1 Phase 2|
Human papilloma viruses (HPV) have been consistently implicated in causing cervical cancer especially those high-risk types (HPV 16, 18, 31, 45). Around 50-80% of women are infected by HPV within their whole lives. The current treatment of HPV-positive mainly includes drug, cryotherapy, laser, microwave, surgery and so on. Some treatments are convenient, but easy to cause pain or infection and there is still a greater risk of recurrence after treatment.
Adoptive immunotherapy with cytotoxic T lymphocytes (CTLs) reactive with specific viral antigens has proven to be effective. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of HPV specific cytotoxic T lymphocytes cells in patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II and Multicenter Trial of HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of Human Papilloma Virus (HPV) Infection|
|Actual Study Start Date :||November 15, 2017|
|Actual Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||December 31, 2021|
Autologous or allogenic HPV specific cytotoxic lymphocytes
2 to 4 infusions, once a week, for 1x10^5~4x10^6 CTLs/kg by IV each time
- Safety of HPV-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)
- Viral load response [ Time Frame: 6 months ]The viral load response to the CTLs infusion will be assessed by HPV specific PCR of peripheral blood.
- Treatment Responses [ Time Frame: 1 year ]Disease status is defined by the biochemical markers (measuring HPV concentration and so on) to get the outcomes such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351855
|Contact: Lung-Ji Chang, PhDemail@example.com|
|Shenzhen Geno-immune Medical Institute||Recruiting|
|Shenzhen, Guangdong, China, 518000|
|Contact: Lung-Ji Chang, PhD 86-075586725195 firstname.lastname@example.org|
|Principal Investigator:||Lung-Ji Chang, PhD||Shenzhen Geno-Immune Medical Institute|