search
Back to results

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

Primary Purpose

Human Papilloma Virus

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HPV-CTLs
Sponsored by
Shenzhen Geno-Immune Medical Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Papilloma Virus focused on measuring Human papilloma virus, Cytotoxic lymphocyte, HPV-CTL

Eligibility Criteria

6 Months - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shenzhen Geno-immune Medical InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HPV-CTLs

Arm Description

Autologous or allogenic HPV specific cytotoxic lymphocytes

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Viral load response
The viral load response to the CTLs infusion will be assessed by HPV specific PCR of peripheral blood.
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).

Full Information

First Posted
November 20, 2017
Last Updated
September 18, 2019
Sponsor
Shenzhen Geno-Immune Medical Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03351855
Brief Title
HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of HPV
Official Title
Phase I/II and Multicenter Trial of HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of Human Papilloma Virus (HPV) Infection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenzhen Geno-Immune Medical Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus
Keywords
Human papilloma virus, Cytotoxic lymphocyte, HPV-CTL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HPV-CTLs
Arm Type
Experimental
Arm Description
Autologous or allogenic HPV specific cytotoxic lymphocytes
Intervention Type
Biological
Intervention Name(s)
HPV-CTLs
Intervention Description
2 to 4 infusions, once a week, for 1x10^5~4x10^6 CTLs/kg by IV each time
Primary Outcome Measure Information:
Title
Safety of HPV-CTLs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
Description
Physiological parameter (measuring cytokine response, fever, symptoms)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Viral load response
Description
The viral load response to the CTLs infusion will be assessed by HPV specific PCR of peripheral blood.
Time Frame
6 months
Title
Treatment Responses
Description
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).
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lung-Ji Chang, PhD
Phone
86-075586725195
Email
c@szgimi.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lung-Ji Chang, PhD
Organizational Affiliation
Shenzhen Geno-Immune Medical Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenzhen Geno-immune Medical Institute
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lung-Ji Chang, PhD
Phone
86-075586725195
Email
c@szgimi.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs