RecruitingPhase 1Phase 2NCT03351855

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

Phase I/II and Multicenter Trial of HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of Human Papilloma Virus (HPV) Infection


Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

100 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 6 MonthsMax Age: 75 Years

Inclusion Criteria12

  • 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.

Exclusion Criteria5

  • 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.

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Interventions

BIOLOGICALHPV-CTLs

2 to 4 infusions, once a week, for 1x10\^5\~4x10\^6 CTLs/kg by IV each time


Locations(1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

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NCT03351855


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