Health TrialsbyHealthPanel

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

ConditionHuman Papilloma Virus
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-75
SponsorShenzhen Geno-Immune Medical Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • HPV-CTLs

    Biological/Vaccine

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: HPV-CTLsExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
6 months

Secondary outcomes

1

Viral load response

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

Time frame
6 months
2

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).

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Geno-Immune Medical Institute

Lead sponsor

Source ClinicalTrials.gov
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