Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Autologous genetically modified gamma-delta T cells
INB-400 · 1 trial · 1 indication
Date of first dose to date of death by any cause
\<30% dose limiting toxicity (DLT) observed with dose
Date of first dose to date of death by any cause
Date of first dose to date of death by any cause
| Arm | Type | Description |
|---|---|---|
| 1) Autologous Newly Diagnosed Disease: Phase 2 Arm A | EXPERIMENTAL | Arm A subjects with newly diagnosed disease will receive autologously derived, genetically modified gamma-delta T cells administered with maintenance temozolomide. |
| 2) Allogeneic Relapsed Disease: Phase 1b and Phase 2 | EXPERIMENTAL | Phase 1b subjects with relapsed disease will have allogeneic derived, genetically modified gamma-delta T cells administered with temozolomide |
| 3) Allogeneic Newly Diagnosed Disease: Phase 2 Arm C | EXPERIMENTAL | Arm C subjects with newly diagnosed disease will receive allogeneic derived, genetically modified gamma-delta T cells administered with maintenance temozolomide. |
| Name | Type | Description |
|---|---|---|
| Autologous genetically modified gamma-delta T cells | BIOLOGICAL | Arm A: Cells will be administered on Day 1 of each of 6, 28-day cycles in combination with TMZ maintenance |
| Allogeneic genetically modified gamma-delta T cells | BIOLOGICAL | Phase 1b and Arm B: Cells will be administered on Day 1 of each of 6, 28-day cycles in combination with D1 of TMZ 150mg/m2 Arms C: Cells will be administered on Day 1 of each of 6, 28-day cycles in combination with TMZ maintenance |
Inclusion Criteria: * Subjects with histologically or cytologically confirmed history of IDH-wild type glioblastoma * Phase 1b and Arm B of Phase 2: Subjects must have completed no more than one standard therapy for glioblastoma, have received no prior Avastin® therapy (unless solely used for ed...