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

NCT03351855 | Recruiting Phase 1

• 1 other identifier: GIMI-IRB-17020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Human Papilloma Virus

Keywords

Human papilloma virus; Cytotoxic lymphocyte; HPV-CTL

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Secondary Outcomes (2)

• Viral load response

  6 months

• Treatment Responses

  1 year

Study Arms (1)

HPV-CTLs

EXPERIMENTAL

Autologous or allogenic HPV specific cytotoxic lymphocytes

Biological: HPV-CTLs

Interventions

HPV-CTLs BIOLOGICAL

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

HPV-CTLs

Eligibility Criteria

• Age: 6 Months - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Shenzhen Geno-Immune Medical Institute: lead

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

Study Officials

• Lung-Ji Chang, PhD

  Shenzhen Geno-Immune Medical Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lung-Ji Chang, PhD

CONTACT

+86 0755-86573763; c@szgimi.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 24, 2017
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 23, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)