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

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ClinicalTrials.gov Identifier: NCT03351855
Recruitment Status : Unknown
Verified September 2019 by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute.
Recruitment status was:  Recruiting
First Posted : November 24, 2017
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute

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

Condition or disease Intervention/treatment Phase
Human Papilloma Virus Biological: HPV-CTLs Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II and Multicenter Trial of HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of Human Papilloma Virus (HPV) Infection
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: HPV-CTLs
Autologous or allogenic HPV specific cytotoxic lymphocytes
 Biological: HPV-CTLs
2 to 4 infusions, once a week, for 1x10^5~4x10^6 CTLs/kg by IV each time


Outcome Measures
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Primary Outcome Measures :
  1. Safety of HPV-CTLs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events [ Time Frame: 6 months ]
    Physiological parameter (measuring cytokine response, fever, symptoms)


Secondary Outcome Measures :
  1. Viral load response [ Time Frame: 6 months ]
    The viral load response to the CTLs infusion will be assessed by HPV specific PCR of peripheral blood.

  2. Treatment Responses [ Time Frame: 1 year ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351855


Contacts
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Contact: Lung-Ji Chang, PhD 86-075586725195 c@szgimi.org

Locations
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China, Guangdong
Shenzhen Geno-immune Medical Institute Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, PhD    86-075586725195    c@szgimi.org   
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
Investigators
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Principal Investigator: Lung-Ji Chang, PhD Shenzhen Geno-Immune Medical Institute
More Information
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Responsible Party: Lung-Ji Chang, President, Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT03351855    
Other Study ID Numbers: GIMI-IRB-17020
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute:
Human papilloma virus
Cytotoxic lymphocyte
HPV-CTL
Additional relevant MeSH terms:
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Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms