Human Papilloma VirusPhase 1/2NCT03351855
HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of HPV
A Phase 1/2 study testing HPV-CTLs in people with Human Papilloma Virus, run by Shenzhen Geno-Immune Medical Institute at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the safety and efficacy of IV-infused autologous or allogenic HPV-CTLs. Read more about this study
- Who is it for?
- Ages 6 months to 75 years
- Conditions the study is for
- Human Papilloma Virus
- What is being tested?
- HPV-CTLs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Jul 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written, informed consent obtained prior to any study-specific procedures.
- Evidence of HPV virus activation (viral DNA) or high risk of HPV infection.
- Not suitable for routine treatment or invalid to antiviral drugs.
- Patients with viral disease symptoms and confirmed by biopsy, regardless of the level of virus DNA.
- Age less than 75 years.
- Did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics.
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- Initial hematopoietic reconstitution: neutrophils (ANC) ≥ 1,000/mm^3, platelet (PLT) ≥ 1,000/mm^3.
- Proper renal and hepatic functions (ULN denotes "upper limit of normal range"): Creatinine ≤ 2*ULN, Bilirubin ≤ 2*ULN, SGOT/ SGPT ≤ 3*ULN.
- If HPV-CTL is not from the patient's own, then the provider of HPV-CTL needs to meet the following criteria:
- did not receive chemotherapy or radiotherapy within 4 weeks prior to blood collection, and did not take any steroids for the previous week, did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics.
- white blood cells ≥ 3,500 / μl, lymphocytes ≥ 750 / μl.
- Human immunodeficiency virus (HIV) test was negative.
Who cannot join
- Subject or the donor of BMT recipient infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.
- Subject is albumin-intolerant.
- Subject with life expectancy less than 8 weeks.
- Subject participated in other investigational somatic cell therapies within past 30 days.
- Subject with positive pregnancy test result.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II and Multicenter Trial of HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of Human Papilloma Virus (HPV) Infection
The purpose of this clinical trial is to evaluate the safety and efficacy of IV-infused autologous or allogenic HPV-CTLs.
Read the detailed description
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.
- Conditions
- Human Papilloma Virus
- Being tested
- HPV-CTLs
- Keywords
- Human papilloma virus, Cytotoxic lymphocyte, HPV-CTL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV-CTLsBiological
2 to 4 infusions, once a week, for 1x10^5~4x10^6 CTLs/kg by IV each time
| Study group | Role | What they receive |
|---|---|---|
| HPV-CTLs | Experimental | Autologous or allogenic HPV specific cytotoxic lymphocytes Receives: Biological: HPV-CTLs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of HPV-CTLs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
Physiological parameter (measuring cytokine response, fever, symptoms)
Measured: 6 months
Secondary outcomes (2)
Viral load response
The viral load response to the CTLs infusion will be assessed by HPV specific PCR of peripheral blood.
Measured: 6 months
Treatment Responses
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Jun 2026
- Primary completion1 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by Shenzhen Geno-Immune Medical InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Geno-Immune Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute
- Investigators
- Lung-Ji Chang, PhD, Principal investigator, Shenzhen Geno-Immune Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351855
- Sponsor's protocol ID
- GIMI-IRB-17020
- Status last verified
- Nov 2026
- First submitted
- 20 Nov 2017
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II and Multicenter Trial of HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of Human Papilloma Virus (HPV) Infection
- ClinicalTrials.gov ID
- NCT03351855
- Acronym / sponsor ID
- GIMI-IRB-17020
- Conditions
- Human Papilloma Virus
- Keywords
- Human papilloma virus, Cytotoxic lymphocyte, HPV-CTL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shenzhen Geno-Immune Medical InstituteUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to evaluate the safety and efficacy of IV-infused autologous or allogenic HPV-CTLs.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV-CTLs | Experimental | Biological: HPV-CTLsAutologous or allogenic HPV specific cytotoxic lymphocytes |
Who may qualify
- Ages
- 6 months to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Written, informed consent obtained prior to any study-specific procedures.
- Evidence of HPV virus activation (viral DNA) or high risk of HPV infection.
- Not suitable for routine treatment or invalid to antiviral drugs.
- Patients with viral disease symptoms and confirmed by biopsy, regardless of the level of virus DNA.
- Age less than 75 years.
Key exclusion criteria (5 listed)
- Subject or the donor of BMT recipient infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.
- Subject is albumin-intolerant.
- Subject with life expectancy less than 8 weeks.
- Subject participated in other investigational somatic cell therapies within past 30 days.
- Subject with positive pregnancy test result.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV-CTLs2 to 4 infusions, once a week, for 1x10^5~4x10^6 CTLs/kg by IV each time | Biological | HPV-CTLs |
Primary outcome
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)
2 secondary outcomes
Viral load response
Time frame: 6 months
Treatment Responses
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lung-Ji Chang, PhD principal investigator
Shenzhen Geno-Immune Medical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HPV-CTLs in people with Human Papilloma Virus, run by Shenzhen Geno-Immune Medical Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of HPV-CTLs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.