Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
E7 TCR-T cells · 2 trials · 23 indications
Objective tumor response as measured by RECIST
Proportion of subjects who complete treatment without an event that meets criteria for feasibility failure
| 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: Subjects must meet all the following criteria to participate in this study. 1. Histologically or cytologically confirmed metastatic or refractory/recurrent HPV-16+ cancer. 2. Tumor and/or blood with HPV16 genotype as determined by testing performed in a Clinical Laboratory Impro...
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