Therapy Detail
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| Therapy Name | Isatuximab |
| Synonyms | |
| Therapy Description |
Sarclisa (isatuximab-irfc) is a humanized monoclonal antibody against CD38 that induces anti-tumor immune reaction against CD38-positive tumor cells (PMID: 24987056). Sarclisa (isatuximab-irfc) in combination with Pomalyst (pomalidomide) and dexamethasone is FDA approved for use in patients with multiple myeloma who have received two or more prior therapies, in combination with Kyprolis (carfilzomib) and dexamethasone for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, and in combination with Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone for patients with newly diagnosed multiple myeloma ineligible for transplant (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Isatuximab | Sarclisa | SAR650984|isatuximab-irfc | CD38 Antibody 20 | Sarclisa (isatuximab-irfc) is a humanized monoclonal antibody against CD38 that induces anti-tumor immune reaction against CD38-positive tumor cells (PMID: 24987056). Sarclisa (isatuximab-irfc) in combination with Pomalyst (pomalidomide) and dexamethasone is FDA approved for use in patients with multiple myeloma who have received two or more prior therapies, in combination with Kyprolis (carfilzomib) and dexamethasone for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, and in combination with Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone for patients with newly diagnosed multiple myeloma ineligible for transplant (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT01084252 | Phase Ib/II | Isatuximab Dexamethasone + Isatuximab | Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies | Completed | USA | TUR | ITA | ISR | GRC | GBR | FRA | FIN | ESP | BRA | BEL | ARG | 5 |
| NCT05284032 | Phase I | Isatuximab | A Pilot Trial Using Isatuximab to Overcome Platelet Transfusion Refractoriness in Human Leukocyte Antigen Allo-Immunized Patients (SuppCare 001) | Terminated | USA | 0 |
| NCT02514668 | Phase I | Isatuximab | A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma | Completed | USA | FRA | CZE | 0 |
| NCT03860844 | Phase II | Idarubicin Cyclophosphamide Isatuximab Doxorubicin Etoposide Daunoxome Cytarabine Methotrexate Daunorubicin Fludarabine Dexamethasone Mitoxantrone Filgrastim Vincristine Sulfate Pegaspargase | Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia | Terminated | USA | SWE | NOR | NLD | ITA | HUN | GRC | FRA | DNK | DEU | BRA | ARG | 4 |
| NCT03367819 | Phase Ib/II | Isatuximab Cemiplimab + Isatuximab | Isatuximab in Combination With REGN2810 in Patients With Advanced Malignancies | Terminated | USA | ITA | GBR | FRA | 1 |
| NCT05346809 | Phase II | Isatuximab | Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma | Recruiting | USA | 0 |
| NCT04802031 | Phase II | Isatuximab | Rapid-infusion Isatuximab in Relapsed/Refractory Multiple Myeloma | Withdrawn | 0 | |
| NCT05665140 | Phase II | Lenalidomide Isatuximab Bortezomib + Dexamethasone + Lenalidomide | Expression-linked and R-ISS-adapted Stratification for First Line Therapy in Multiple Myeloma Patients (ELIAS) | Recruiting | DEU | 0 |
| NCT03637764 | Phase Ib/II | Atezolizumab + Isatuximab Isatuximab | Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies | Terminated | USA | NLD | ITA | ESP | CZE | CAN | BEL | 1 |
| NCT02999633 | Phase II | Isatuximab | Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia (ISLAY) | Terminated | USA | LTU | ITA | HUN | FRA | FIN | 1 |
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