Recurrent HPV16-positive cervical cancer
Conditions
Interventions
rejT-H01 administration
Sponsors
Ando Miki
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. HPV16-positive cervical cancer 2. Patients with Performance status 0 to 2 as defined by the Eastern Cooperative Group 3. Patients between 20 and 75 years old at the time of enrollment in the study 4. Patients with recurrent HPV16-positive cervical cancer who have been diagnosed with a second or subsequent recurrence and for whom at least 21 days have passed since the most recent treatment 5. Patient with HLA-A*2402 by HLA-A, B, C, DRB1 locus genotyping 6. Patients with no serious organ damage, no serious bleeding tendency, and meet the following criteria Creatinine = 500 /ul Platelet count >= 20000 /ul Blood oxygen saturation >= 93% (indoor air) 7. Patients who comprehend the nature of the treatment and can provide voluntary consent in writing based on their own free will 8. Patients who consent to contraception during the clinical trial period
Exclusion criteria
Exclusion criteria: 1. Patients with severe cardiac disease 2. patients with a history of severe cerebrovascular disease or its sequelae such as paralysis 3. Active or serious concomitant infections 4. Patients who are positive for HIV antibodies 5. Patients who are positive for HBs antigen or positive for HBc antibody and HBV-DNA 6. Patients with active HCV infection 7. Patients with psychiatric disorders, drug addiction, or other illnesses that would affect their consent to this study 8. Pregnant, lactating, women of childbearing potential, or women who wish to become pregnant during the study period 9. Other cases in which participation in the study is deemed inappropriate by the physician in charge 10. Patients with a history of hypersensitivity to components (animal-derived ingredients) used in the manufacturing process of the product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation 1. Incidence of adverse events (grade based on CTCAE ver. 5.0) 2. Grade of Cytokine Release Syndrome 3. GvHD severity (grading based on the hematopoietic cell transplantation guideline GvHD 4th edition) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation 1 Progression free survival 2 Tumor suppressive effect ORR, best overall response 3 Changes in the number of HPV-specific CTL cells in peripheral blood by MHC tetramer | — |
Contacts
Public ContactYasuhisa Terao
Juntendo University School of Medicine
Outcome results
None listed