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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04984837 | Study of Lacutamab in Peripheral T-cell Lymphoma | PHASE2 | RECRUITING | 56 | — | — | Oct 5, 2021 | Apr 30, 2028 | Apr 20, 2026 | 64 | Belgium, France +2 |
| NCT05321147 | Safety and Efficacy of Lacutamab in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma That Express KIR3DL2 | PHASE1 | COMPLETED | 20 | — | — | Mar 17, 2022 | Feb 8, 2024 | Mar 28, 2024 | 20 | United States, South Korea |
time from randomization until one of the following events occurs, whichever comes first: 1. Disease progression (PD) 2. Administration of any additional unplanned anti-lymphoma treatment (except allogeneic or autologous hematopoietic cell transplantations (HCT)) 3. Relapse after achievement of CR 4. Death due to any cause. PD and relapse will be evaluated according to Lugano 2014 criteria (CT-based).
Frequency and intensity of adverse events and serious adverse events.
| Arm | Type | Description |
|---|---|---|
| Lacutamab | EXPERIMENTAL | Lacutamab 750 mg/IV + GEmOx (1000 mg/m² / 100 mg/m²) 6 cycles of 3 weeks (4,5 months) during the induction phase Lacutamab 750 mg/IV for a maximum of 20 additional cycles of 4 weeks during the maintenance phase |
| Standard of care | ACTIVE_COMPARATOR | GemOx (1000 mg/m² / 100 mg/m²) 6 cycles of 3 weeks (4,5 months) during the induction phase |
| PTCL that express KIR3DL2 | EXPERIMENTAL | lacutamab will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Lacutamab | DRUG | 750 mg/IV |
| Gemcitabine | DRUG | 1000 mg/m² |
| Oxaliplatine | DRUG | 100 mg/m² |
Inclusion Criteria: * 1\. KIR3DL2-positive with at least 1% of tumour cells positivity, before randomization, based on central evaluation by immunohistochemistry (IHC) 2. Patients with histologically documented PTCL: * Biopsy-proven treated PTCL defined by the WHO 2016 criteria (the biopsy at re...