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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04991948 | Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer | PHASE1 | RECRUITING | 34 | — | — | Nov 22, 2021 | May 25, 2038 | Mar 9, 2022 | 5 | United States, Belgium |
The occurrence of DLT during the 'DLT reporting period' is defined as the period from study enrollment on D1 (Visit 1) up to 3 weeks after first pembrolizumab treatment on D73 (Visit 14).
The objective response rate (ORR) at the tumor assessment on Day 94 \[Visit 15\]), 6 weeks after the first pembrolizumab treatment administration.
| Arm | Type | Description |
|---|---|---|
| CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CYAD-101 | DRUG | Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells |
| FOLFOX | DRUG | 5-FU, leucovorin and oxaliplatin |
| Pembrolizumab | DRUG | Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) |
Key Inclusion Criteria: 1. Histologically proven metastatic adenocarcinoma of the colon or rectum. 1. Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum. 2. Confirmed non-microsatellite instability high (non-MSI-H)/mismatch-repair proficient (pMMR) tumor status 3....