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RecruitingNCT05895370GI-HPVT-01Updated Jun 8, 2023

HPV-T in HPV-16 Positive Recurrent or Metastatic Solid Tumors

A Phase 1 interventional study of HPV-T and Interleukin-2 in Solid Tumor, sponsored by BGI, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-08.

Sponsored by BGI, China · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 5 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this protocol is to evaluate the feasibility and safety of HPV-T in HPV 16 positive recurrent or metastatic solid tumor patients.

Read the detailed description

In this study, HPV-T cells will be cultured from mononuclear cells collected from participant's peripheral blood in the laboratory and they will be given back to the participant intravenously. The use of HPV-T cells involves a combination of IL-2, which is a drug used to help the body's response to treatment on the immune system. A medium dose regimen of IL-2 will be given after the participant receives the infusion of the T-cells.

Each HPV-T cell reinfusion is a treatment cycle, and each participant will receive a maximum of four cycles of HPV-T treatment. Whether the participant receives the next cycle of treatment depends on the efficacy of the previous HPV-T treatment, which is assessed by imaging.

02

Conditions studied

  • Solid Tumor

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Keywords

  • HPV-16 Positive
  • Adoptive T Cell Therapy
  • Recurrent or Metastatic Cervical Cancer
  • HPV-T
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 12 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

BGI, China is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Greater than or equal to 18 years of age and less than or equal to 75 years of age; all genders.
  2. Confirmed diagnosis of recurrent of metastatic solid tumor and at least one measurable lesion.
  3. HLA type is HLA-A0201.
  4. HPV 16 positive.
  5. Patients who failed or were intolerant to standard first-line treatment.
  6. Possess venous access for mononuclear cell collection or intravenous blood collection.
  7. Clinical performance status of ECOG is 0 or 1.
  8. Possess venous access for mononuclear cell collection or intravenous blood collection.
  9. Patients who are able to cooperate to observe adverse reactions and the effect of the treatment,expected lifetime is greater than six month.
  10. Patients of both genders must be willing to practice birth control from the time of enrollment to three months after treatment on this study,a fertile woman must have a negative pregnancy test.
  11. The laboratory test values and the functions of important organs meet the following requirements:

1#Serology: HIV antibody(-), hepatitis B DNA(-), hepatitis C antibody(-) and no active syphilis infection; 2#Hematology: Absolute neutrophil count is greater than or equal to 1.5×10\^9/L; WBC is greater than or equal to 3×10\^9/L; lymphocyte count is greater than or equal to 0.8×10\^9/L; Platelet count is greater than or equal to 100×10\^9/L; Hemoglobin is greater than or equal to 85g/L ; 3#Chemistry: Serum ALT/AST is less than or equal to 3 times ULN,except in patients with liver metastasis who must have ALT/AST less than or equal to 5 times ULN; Serum Creatinine is less than or equal to 1.5 times ULN ; Total bilirubin is less than or equal to 1.5 times ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3 times ULN; 4#Blood Clotting Parameters:Prothrombin Time(PT) and International Normalised Ratio (INR) are less than or equal to 1.5 times ULN;Activated Partial Thromboplastin Time (APTT) is less than or equal to 1.5 times ULN;For subjects who frequently take anticoagulant drugs,their blood clotting parameters can meet the value range adoptive to this special population; 5#Left ventricular ejection fraction#LVEF#is more than or equal to 50%. 12. More than four weeks must have elapsed since any prior systemic therapy (except for bridging therapy) at the time the patient receives the lymphodepletion regimen, and toxicities must have recovered to grade 1 or less (except for toxicities such as alopecia or vitiligo)

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. History of severe immediate hypersensitivity reaction to HPV-T and any of the agents used in this study.
  3. Participants with a history of organ transplantation.
  4. Participants with brain metastases.
  5. Any active autoimmune disease or participants with a history of autoimmune diseases that have been assessed by the investigator to be unsuitable for this study. Including but not limited to the following diseases: such as systemic lupus erythematosus, immune related neuropathy, multiple sclerosis, Guillain Barre syndrome, myasthenia gravis, connective tissue diseases, inflammatory bowel diseases(Crohn's disease and ulcerative colitis), excluding vitiligo, eczema, type I diabetes, rheumatoid arthritis and other joint diseases, Sjogren's syndrome and controlled psoriasis by local medication.
  6. Active systemic infections, for example, acute infections requiring systemic antibiotic, antiviral, or antifungal treatment occur within 2 weeks before enrollment.
  7. Severe liver and kidney function damage(given treatment is still uncontrollable, and biochemical indicators cannot meet the Exclusion Criteria of 11th), uncontrollable diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or poorly controlled hypertension (systolic pressure>160mmHg and/or diastolic pressure>90mmHg); active cardiovascular and cerebrovascular diseases, such as acute stroke, myocardial infarction, unstable angina, congestive heart failure rated as Grade II or above by the New York Heart Association, severe cardiac arrhythmias that cannot be controlled with medication, electrocardiograms show significant abnormalities (three consecutive times with an interval of at least 5 minutes) which have been assessed by the investigator that affect subsequent cellular treatment; mental illness and drug abuse, or any situation that the investigator assessments may increase the risk of this study.
  8. Participants plan to receive glucocorticoid (the dose of prednisone or alternative drug is more than 10mg per day) or other immunosuppressant within 4 weeks before the administration of lymphocyte clearance. Tips: when there is no active autoimmune disease, it is allowed to use prednisone or alternative drug with a dose less than 10 mg per day; Allowing participants to use topical, ocular, intra articular, intranasal, and inhaled glucocorticoids for treatment.
  9. Participants plan to receive immunomodulatory drugs (such as interferon, GM-CSF, thymosin, gamma globulin, excluding IL-2) within 4 weeks before the administration of lymphocyte clearance.
  10. The investigator assessed that the subject was unable or unwilling to comply with the requirements of the study protocol.
  11. With a history of other malignant tumors.
  12. The participant has any disease or medical condition that may affect the safety or effectiveness evaluation of the study treatment.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    HPV-T

    Participants in the 2 dose groups will receive HPV-T injections of 5×10\^9 and 1.5×10\^10 cells intravenously each time.

    Biological: HPV-T · Drug: Interleukin-2

Interventions

  • BiologicalHPV-T

    Participant will receive HPV-T iv on day 0. One time of cell infusion constitute a cycle, each participant receives up to four cycles of treatment

  • DrugInterleukin-2

    500,000IU/m\^2 SC, after each cell infusion, IL-2 will start within 24 hours and every 8-12 hours for up to 6 doses.

    Also known as: IL-2

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events as assessed by CTCAE v5.0

    Toxicity will be assessed within 4 weeks of the HPV-T transfer.

    Time frame: Up to 24 months

Secondary outcomes

  1. Number of Participants With Objective Response

    Participants displaying objective response associated with the treatment regimen per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1). The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Disease control rate (DCR), Duration of Response (DOR), Overall Survival(OS) and Progression-free survival (PFS) will be also evaluated.

    Time frame: Up to 24 months

07

Study locations

1 of 1 sites recruiting
  • Wuhan Union Hospital
    Wuhan, Hubei 430000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05895370
Lead sponsor
BGI, China
Collaborators
Wuhan Union Hospital, China
Responsible party
Sponsor
First posted
Jun 8, 2023
Start date
Apr 13, 2023
Primary completion
Dec 13, 2024 (estimated)
Completion
Apr 13, 2025 (estimated)
Last update
Jun 8, 2023

Study contacts

Guiling Li, Doctor
Contact
Lg16714@163.com
027-85873129

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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