NCT03351855

TerminatedPhase 1/2

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

Shenzhen Geno-Immune Medical Institute Source

Compare

Other study identifiers

Sponsor study identifier

GIMI-IRB-17020

Study Type

interventional

Actual enrollment (reported)

100

Locations

1 country

Sites

1

Timeline

Study Start

June 1, 2026

Actual (reported)

Primary Completion

July 1, 2026

Actual (reported)

Study Completion

July 31, 2026

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 100 participants
Study completion date: July 31, 2026
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 20, 2017
Actual (reported)
First Posted
November 24, 2017
Actual (reported)
Study Start
June 1, 2026
Actual (reported)
Primary Completion
July 1, 2026
Actual (reported)
Study Completion
July 31, 2026
Actual (reported)

Last Updated: August 24, 2026
Status Verified: August 2026
Last Update Submitted: August 21, 2026

Conditions

Human Papilloma Virus

Keywords

Human papilloma virusCytotoxic lymphocyteHPV-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-CTLsBiological

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

HPV-CTLs

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age6 Months - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (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.

Sponsors & Collaborators

Shenzhen Geno-Immune Medical Institute
Otherlead

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

Study Officials

Lung-Ji Chang, PhD
Shenzhen Geno-Immune Medical Institute
PRINCIPAL INVESTIGATOR

Enrollment

100 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
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

Actual (reported)

NCT06414057

HPV Equity Study: Exploring Cervical Cancer Control in Scotland for Women With Experience of Priority Risks

Recruiting

NCT06229353

Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department

Terminated

NCT07110909

Impact of HPV Education on Knowledge, Awareness, and Concern

Not ApplicableCompleted

NCT07418203

Knowledge of 18-19 Years Old About Papillomavirus and HPV Vaccination

Completed

NCT06909370

Peer Education on HPV: Impact on Health Sciences Students' Knowledge, Awareness, and Concern

Not ApplicableCompleted

NCT05365048

Provider Recommendation and HPV Vaccination

Not ApplicableRecruiting

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.

Contact the study team to confirm eligibility.

Primary Completion

July 1, 2026

Actual (reported)

Study Completion

July 31, 2026

Actual (reported)

Last Updated

August 24, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03351855
Data provider: ClinicalTrials.gov
Source updated: 2026-08-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:04 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

HPV-CTLs

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations