HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of HPV

Recruiting now · Phase 1/Phase 2

Conditions studied: Human Papilloma Virus

In brief

The purpose of this clinical trial is to evaluate the safety and efficacy of IV-infused autologous or allogenic HPV-CTLs.

Key facts

Study ID

NCT03351855

Run by

Shenzhen Geno-Immune Medical Institute

People needed

100

Starts

2026-06-01

Expected to finish

2030-12-31

Last updated by the study team

2026-06-23

Who can join

Age: 1 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.

Where it is running

• Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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