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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06236425 | TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC | PHASE1 | ACTIVE NOT_RECRUITING | 7 | — | — | Mar 14, 2024 | Aug 1, 2026 | Apr 1, 2026 | 1 | United States |
The incidence of treatment-emergent adverse events will be tabulated using NCI CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| TIL Harvest/Standard of care Treatment Phase | OTHER | Participants will undergo tumor harvest for TIL and then receive 2 to 3 cycles of pembrolizumab or pembrolizumab/platinum chemotherapy (cisplatin or carboplatin / 5-FU) as per standard of care. |
| TBio-4101 Treatment | EXPERIMENTAL | Participants without radiographic response (progressive disease) after pembrolizumab or pembrolizumab/platinum chemotherapy, and who meet eligibility requirements, will transition to receive TBio-4101. Participants will receive TBio-4101 infusion and after completion of TBio-4101 infusion, IL-2 will be administered every 8 hours, for up to 6 doses. Finally, pembrolizumab will be administered on Day 14, Day 35, and Day 56 and Q6W (beginning Week 12) thereafter for up to 2 years until discontinuation. |
| Name | Type | Description |
|---|---|---|
| TBio-4101 | BIOLOGICAL | TBio-4101 is a tumor-infiltrating lymphocyte (TIL) product that involves the use of special immune cells called T-cells. A T-cell is a type of lymphocyte, or white blood cell. |
| Pembrolizumab | DRUG | Will be administered as per standard of care. Participants with initial partial or complete radiographic response will continue on the same therapy at the discretion of the treating physician. |
| Platinum based chemotherapy | DRUG | Will be administered as per standard of care. Participants with initial partial or complete radiographic response will continue on the same therapy at the discretion of the treating physician. |
| Cyclophosphamide | DRUG | Participants who proceed to TBio-4101 treatment will receive Cyclophosphamide as part of a non-myeloablative lymphodepletion (NMA-LD) chemotherapy regimen prior to TBio-4101 infusion. |
| Fludarabine | DRUG | Participants who proceed to TBio-4101 treatment will receive Fludarabine as part of a non-myeloablative lymphodepletion (NMA-LD) chemotherapy regimen prior to TBio-4101 infusion. |
| Aldesleukin | DRUG | After completion of TBio-4101 infusion, Aldesleukin will be administered every 8 hours, for up to 6 doses. |
Inclusion Criteria: * Patients must have pathologically confirmed, recurrent, unresectable or metastatic solid tumors of HNSCC, excluding nasopharyngeal and nasal cavity carcinomas, and must have received no prior treatment for metastatic disease. * Patients must have at least 1 cm3 (1.1 g) of viab...