Solid TumorPhase 1GI-HPVT-01NCT05895370
HPV-T in HPV-16 Positive Recurrent or Metastatic Solid Tumors
A Phase 1 study testing HPV-T and Interleukin-2 in people with Solid Tumor, run by BGI, China at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- HPV-T and Interleukin-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2023to 13 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than or equal to 18 years of age and less than or equal to 75 years of age; all genders.
- Confirmed diagnosis of recurrent of metastatic solid tumor and at least one measurable lesion.
- HLA type is HLA-A0201.
- HPV 16 positive.
- Patients who failed or were intolerant to standard first-line treatment.
- Possess venous access for mononuclear cell collection or intravenous blood collection.
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- Clinical performance status of ECOG is 0 or 1.
- Possess venous access for mononuclear cell collection or intravenous blood collection.
- Patients who are able to cooperate to observe adverse reactions and the effect of the treatment,expected lifetime is greater than six month.
- 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.
- 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)
Who cannot join
- Pregnant or lactating women.
- History of severe immediate hypersensitivity reaction to HPV-T and any of the agents used in this study.
- Participants with a history of organ transplantation.
- Participants with brain metastases.
- 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.
- Active systemic infections, for example, acute infections requiring systemic antibiotic, antiviral, or antifungal treatment occur within 2 weeks before enrollment.
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- 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.
- 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.
- 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.
- The investigator assessed that the subject was unable or unwilling to comply with the requirements of the study protocol.
- With a history of other malignant tumors.
- The participant has any disease or medical condition that may affect the safety or effectiveness evaluation of the study treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430000
Guiling Li, doctor, Lg16714@163.com
About this study
Official title: A Phase 1 Study to Assess the Feasibility and Safety of Tumor HPV-E6/E7-Targeting T Cell Suspension for Intravenous Infusion (HPV-T) in Patients With HPV-16 Positive Recurrent or Metastatic Solid Tumor
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.
- Conditions
- Solid Tumor
- Being tested
- HPV-T, Interleukin-2
- Keywords
- HPV-16 Positive, Adoptive T Cell Therapy, Recurrent or Metastatic Cervical Cancer, HPV-T
- Medical subject headings
- Recurrence, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV-TBiological
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
Interleukin-2Drug
Also called IL-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.
| Study group | Role | What they receive |
|---|---|---|
| HPV-T | Experimental | Participants in the 2 dose groups will receive HPV-T injections of 5×10^9 and 1.5×10^10 cells intravenously each time. Receives: Biological: HPV-T; Drug: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as assessed by CTCAE v5.0
Toxicity will be assessed within 4 weeks of the HPV-T transfer.
Measured: 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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start13 Apr 2023
- Primary completion13 Dec 2024 (estimated)
- Study completion13 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BGI, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895370
- Sponsor's protocol ID
- BGI-005
- Acronym
- GI-HPVT-01
- Status last verified
- May 2023
- First submitted
- 31 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Feasibility and Safety of Tumor HPV-E6/E7-Targeting T Cell Suspension for Intravenous Infusion (HPV-T) in Patients With HPV-16 Positive Recurrent or Metastatic Solid Tumor
- ClinicalTrials.gov ID
- NCT05895370
- Acronym / sponsor ID
- GI-HPVT-01 / BGI-005
- Conditions
- Solid Tumor
- Keywords
- HPV-16 Positive, Adoptive T Cell Therapy, Recurrent or Metastatic Cervical Cancer, HPV-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- BGI, ChinaUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 13 Dec 2024 (estimated)
- Study completion
- 13 Apr 2025 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV-T | Experimental | Biological: HPV-T, Drug: Interleukin-2Participants in the 2 dose groups will receive HPV-T injections of 5×10^9 and 1.5×10^10 cells intravenously each time. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Greater than or equal to 18 years of age and less than or equal to 75 years of age; all genders.
- Confirmed diagnosis of recurrent of metastatic solid tumor and at least one measurable lesion.
- HLA type is HLA-A0201.
- HPV 16 positive.
- Patients who failed or were intolerant to standard first-line treatment.
Key exclusion criteria (12 listed)
- Pregnant or lactating women.
- History of severe immediate hypersensitivity reaction to HPV-T and any of the agents used in this study.
- Participants with a history of organ transplantation.
- Participants with brain metastases.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV-TParticipant 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 | Biological | HPV-T |
| Interleukin-2Also: IL-2500,000IU/m^2 SC, after each cell infusion, IL-2 will start within 24 hours and every 8-12 hours for up to 6 doses. | Drug | HPV-T |
Primary outcome
Number of participants with adverse events as assessed by CTCAE v5.0
Time frame: Up to 24 months
Toxicity will be assessed within 4 weeks of the HPV-T transfer.
1 secondary outcome
Number of Participants With Objective Response
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HPV-T and Interleukin-2 in people with Solid Tumor, run by BGI, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guiling Li, Doctor (027-85873129, Lg16714@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as assessed by CTCAE v5.0 (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.