HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatme... | NCT03351855

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

NCT03351855

Sponsor

Shenzhen Geno-Immune Medical Institute

Status

Recruiting

Last Update Posted

Jun 23, 2026Actual

Enrollment

100Estimated

Phase

Phase 1Phase 2

Conditions

Human Papilloma Virus

Interventions

HPV-CTLs

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2026Actual

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Nov 20, 2017

First Submission Date that Met QC Criteria

Nov 20, 2017

First Posted Date

Nov 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2026

Last Update Posted Date

Jun 23, 2026Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
HPV-CTLs	Experimental	Autologous or allogenic HPV specific cytotoxic lymphocytes	Biological: HPV-CTLs

Name	Type	Description	Arm Group Labels	Other Names
HPV-CTLs	Biological	2 to 4 infusions, once a week, for 1x10^5~4x10^6 CTLs/kg by IV each time	HPV-CTLs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Viral load response	The viral load response to the CTLs infusion will be assessed by HPV specific PCR of peripheral blood.	6 months
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).

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided