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Immune cell therapy takes on HPV

NCT ID NCT03351855

Disease control Sponsor: Shenzhen Geno-Immune Medical Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This trial tests whether infusing HPV-specific immune cells (HPV-CTLs) can safely reduce or clear HPV infection in people who haven't responded to standard treatments. Up to 100 participants will receive 2 to 4 infusions of these cells. The study measures safety and viral load changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HPV-specific immune cells (HPV-CTLs)
What this could lead to
If successful, this could offer a new treatment option for persistent HPV infections that don't respond to standard therapies.
What could go wrong
This is an early phase 1/2 trial with only 100 participants, so results may not apply broadly. Risks include immune reactions or lack of viral clearance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

100 people

The number who actually took part.

Started

Jun 2026

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Written, informed consent obtained prior to any study-specific procedures. 2. Evidence of HPV virus activation (viral DNA) or high risk of HPV infection. 3. Not suitable for routine treatment or invalid to antiviral drugs. 4. Patients with viral disease symptoms and confirmed by biopsy, regardless of the level of virus DNA. 5. Age less than 75 years. 6. Did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics. 7. Initial hematopoietic reconstitution: neutrophils (ANC) ≥ 1,000/mm\^3, platelet (PLT) ≥ 1,000/mm\^3. 8. Proper renal and hepatic functions (ULN denotes "upper limit of normal range"): Creatinine ≤ 2\*ULN, Bilirubin ≤ 2\*ULN, SGOT/ SGPT ≤ 3\*ULN. 9. 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. 10. Human immunodeficiency virus (HIV) test was negative. Exclusion Criteria: 1. 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. 2. Subject is albumin-intolerant. 3. Subject with life expectancy less than 8 weeks. 4. Subject participated in other investigational somatic cell therapies within past 30 days. 5. Subject with positive pregnancy test result.

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Conditions

The condition(s) this trial relates to.

human papilloma virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Human papilloma virus

Contacts and locations

Locations

  • Shenzhen Geno-immune Medical Institute

    Shenzhen, Guangdong, 518000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.