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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06561425 | A Study Evaluating the Safety and Efficacy of GLPG5101 (19CP02) in Participants With Non-Hodgkin Lymphoma | PHASE1 | ACTIVE NOT_RECRUITING | 130 | — | — | Mar 9, 2022 | Jul 1, 2029 | Jun 8, 2026 | 11 | United States, Belgium +2 |
For all cohorts
| Arm | Type | Description |
|---|---|---|
| Phase 1 (Dose escalation phase): Dose level 1 | EXPERIMENTAL | Participants will receive a single dose of GLPG5101 intravenous (IV) cell suspension for infusion at dose level 1 on Day 0. |
| Phase 1 (Dose escalation phase): Dose level 2 | EXPERIMENTAL | Participants will receive a single dose of GLPG5101 IV cell suspension for infusion at dose level 2 on Day 0. |
| Phase 1 (Dose escalation phase): Dose level 3 | EXPERIMENTAL | Participants will receive a single dose of GLPG5101 IV cell suspension for infusion at dose level 3 on Day 0. |
| Phase 2 (Dose expansion phase): Cohort 1a: DLBCL 2L+ | EXPERIMENTAL | Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0 |
| Phase 2 (Dose expansion phase): Cohort 1b: DLBCL 2L+ SCNSL | EXPERIMENTAL | Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0 |
| Phase 2 (Dose expansion phase): Cohort 2: High-risk first-line DLBCL | EXPERIMENTAL | Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0 |
| Phase 2 (Dose expansion phase): Cohort 3: Indolent B-cell NHL (FL and MZL 3L+) | EXPERIMENTAL | Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0 |
| Phase 2 (Dose expansion phase): Cohort 4: MCL 2L+ | EXPERIMENTAL | Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0 |
| Phase 2 (Dose expansion phase): Cohort 5: BL 2L+ | EXPERIMENTAL | Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0 |
| Phase 2 (Dose expansion phase): Cohort 6a: PCNSL 2L+ | EXPERIMENTAL | Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0 |
| Phase 2 (Dose expansion phase): Cohort 6b: PCNSL first-line consolidation | EXPERIMENTAL | Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0 |
| Phase 2 (Dose expansion phase): Cohort 7: DLBCL-RT 2L+ | EXPERIMENTAL | Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0 |
| Experimental: Phase 2 (Dose expansion phase): Cohort 8 CLL/SLL (r/r) | EXPERIMENTAL | Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0 |
| Name | Type | Description |
|---|---|---|
| GLPG5101 | GENETIC | Autologous anti-CD19 chimeric antigen receptor (CAR) T cell therapy |
Key Inclusion Criteria: * Histologically confirmed diagnosis of one of the following NHL subtypes: DLBCL, FL grade 1, 2 or 3A, MZL, MCL, BL, PCNSL, DLBCL-RT, High Grade B-cell Lymphoma (HGBL), CLL/SLL * Relapsed or refractory disease * Presence of at least one measurable lesion according to the Lug...