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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 monoclonal antibody being developed by Innate Pharma S.A. for the treatment of peripheral T cell lymphoma, a type of non-Hodgkin lymphoma. It is designed to target cancer cells that express the KIR3DL2 protein and is currently in clinical development.
Lacutamab is being studied for the treatment of peripheral T cell lymphoma, including relapsed or refractory disease. Clinical trials have enrolled adults with this condition, and one study specifically selected patients whose tumors express KIR3DL2. It is not yet approved for commercial use.
Lacutamab targets KIR3DL2, a receptor found on certain T cell lymphoma cells. It acts as an antagonist antibody directed at this target. By binding KIR3DL2, lacutamab is designed to affect the survival of malignant T cells that express the protein.
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 trials evaluating lacutamab in peripheral T cell lymphoma.
Lacutamab is in clinical development, with trials conducted in Phase 1 and Phase 2. It is an investigational agent and has not been approved by the FDA. A Phase 1 study has been completed, and a Phase 2 study is currently recruiting participants.
Lacutamab has been evaluated in two registered trials. NCT05321147 was a completed Phase 1 study in relapsed or refractory peripheral T cell lymphoma expressing KIR3DL2, conducted in the United States and South Korea. NCT04984837 is a recruiting Phase 2 study in peripheral T cell lymphoma across Belgium, France, Germany, and Spain.