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

NCT05895370 | Unknown Phase 1 DMC

• 1 other identifier: BGI-005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor

Keywords

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

Outcome Measures

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.

  Up to 24 months

Secondary Outcomes (1)

• Number of Participants With Objective Response

  Up to 24 months

Study Arms (1)

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.

Biological: HPV-T; Drug: Interleukin-2

Interventions

HPV-T BIOLOGICAL

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

HPV-T

Interleukin-2 DRUG

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

HPV-T

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:
• #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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• BGI, China: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Uterine Cervical Neoplasms

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Central Study Contacts

Guiling Li, Doctor

CONTACT

027-85873129; Lg16714@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 8, 2023
• Study Start: April 13, 2023
• Primary Completion: December 13, 2024
• Study Completion: April 13, 2025
• Last Updated: June 8, 2023

Record last verified: 2023-05

Locations

CN (1)