Approval Probability
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Also known as IPH4102
Lacutamab · 4 trials · 6 indications
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).
Using the Olsen (2011, JCO) criteria (All cohorts)
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 |
| Cohort 1: Relapsed/refractory Sezary Syndrome | EXPERIMENTAL | IPH4102 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. |
| Cohort 2: Stage IB-IV Mycosis Fungoides, KIR3DL2 expressing | EXPERIMENTAL | IPH4102 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. |
| Cohort 3: Stage IB-IV Mycosis Fungoides,KIR3DL2 non-expressing (closed) | EXPERIMENTAL | IPH4102 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. |
| Cohort All comers: Stage IB-IV Mycosis Fungoides,KIR3DL2 expressing and non-expressing | EXPERIMENTAL | IPH4102 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. |
| 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. |
| IPH4102 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Lacutamab | DRUG | 750 mg/IV |
| Gemcitabine | DRUG | 1000 mg/m² |
| Oxaliplatine | DRUG | 100 mg/m² |
| IPH4102 | BIOLOGICAL | Patients will receive a flat dose of 750mg |
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...
Lacutamab is an investigational biologic being studied for the treatment of peripheral T cell lymphoma, a type of non-Hodgkin lymphoma. It is in clinical development for patients with relapsed or refractory disease whose tumors express KIR3DL2. It has not been established as a marketed treatment.
Lacutamab targets KIR3DL2, a receptor found on certain T cell lymphoma cells. It is an antagonist directed at this target. By binding KIR3DL2, lacutamab is designed to act on lymphoma cells that express the receptor, which is why study enrollment focuses on KIR3DL2-expressing peripheral T cell lymphoma.
Lacutamab is being developed by Innate Pharma S.A., a biopharmaceutical company whose shares trade under the ticker IPHA. Innate Pharma is the sponsor of the clinical program evaluating lacutamab in peripheral T cell lymphoma.
Lacutamab is in Phase 1 and Phase 2 clinical development for peripheral T cell lymphoma. It is investigational and is not an approved therapy. Its trial program includes a completed Phase 1 study and a Phase 2 study that is active but no longer recruiting participants.
Lacutamab has been studied in two registered trials in peripheral T cell lymphoma. NCT05321147 was a completed Phase 1 study of 20 patients in the United States and South Korea. NCT04984837 is a Phase 2 study of 49 patients in Belgium, France, Germany, and Spain that is active but not recruiting.