Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05686226 | E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers | PHASE2 | RECRUITING | 20 | — | — | Mar 7, 2023 | Jan 1, 2027 | Feb 27, 2026 | 3 | United States |
Objective tumor response as measured by RECIST
| Arm | Type | Description |
|---|---|---|
| E7 TCR-T cells | EXPERIMENTAL | Subjects will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. |
| Name | Type | Description |
|---|---|---|
| E7 TCR-T cells | BIOLOGICAL | Participants will receive a conditioning regimen consisting of cyclophosphamide and fludarabine. E7 TCR-T cells will be administered as a single intravenous infusion. |
| Aldesleukin | DRUG | Within 24 hours after E7 TCR-T cell infusion, aldesleukin 720,000 IU/kg IV every eight hours will be administered for up to six doses. Aldesleukin dosing will be stopped for aldesleukin-related grade 3 or greater toxicity other than flushing, fever, chills, or hemodynamic changes (tachycardia or hypotension) that respond to crystalloid infusion. Aldesleukin may also be stopped at any time at investigator discretion. |
Inclusion Criteria: 1. Histologically or cytologically confirmed metastatic or refractory/recurrent HPV-16+ cancer. 2. Tumor with HPV16 genotype as determined by testing performed in a CLIA certified laboratory. 3. HLA-A\*02:01 allele as determined by testing performed in a Clinical Laboratory Impr...