Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CellProtect · 1 trial · 1 indication
Evaluate in both arms the occurance after maintenance start of: Very good partial response (VGPR) or better rate, as defined by the International Myeloma Working Group (IMWG) criteria.
Assessment of changes in MRD negativity rate in patients with complete and very good partial response as well as conversion of MRD positivity to MRD negativity.
| Arm | Type | Description |
|---|---|---|
| A - Isatuximab/CellProtect | EXPERIMENTAL | Isatuximab will be given intravenously (IV) at the dose of 10 mg/kg on Days 1, 8, 15, 22 (cycle 1), 36, 50 (cycle 2), 64, 78 (cycle 3) and monthly thereafter (cycles 4-36). CellProtect will be given IV infusion at the dose of 3x10\^7 cells/kg day 29 , 43 and 3-10x10\^7 on day 57. Each cycle will be 28 days, after completion of third cycles, patients will continue with Isatuximab alone until disease progression, unacceptable AE, death, completion of 3 years of treatment or patient's decision to discontinue, whichever occurs first. |
| B - Isatuximab | ACTIVE_COMPARATOR | Isatuximab will be given intravenously (IV) at the dose of 10 mg/kg on Days 1, 8, 15, 22 (cycle 1), 36, 50 (cycle 2), 64, 78 (cycle 3) and monthly thereafter (cycles 4-36). Each cycle will be 28 days, after completion of third cycles, patients will continue with Isatuximab alone until disease progression, unacceptable AE, death, completion of 3 years of treatment or patient's decision to discontinue, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| CellProtect | DRUG | In vitro expanded and activated autologous NK cells |
| Isatuximab | DRUG | Naked immunoglobulin (Ig) G1 monoclonal antibody (mAb) that selectively binds to the human cell surface antigen molecule classified as cluster of differentiation (CD) 38 |
Inclusion Criteria: I1. Active multiple myeloma, as defined by the IMWG criteria. I2. Evidence of measurable disease: I3. Serum monoclonal (M)-protein ≥1.0 g/dL measured using serum protein immunoelectrophoresis a.and/or I4. Urine M-protein ≥200 mg/24 hours measured using urine protein immunoelec...
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CellProtect is an investigational small molecule being studied for the treatment of Multiple Myeloma. It is currently in Phase 2 clinical development, with an active trial evaluating its use as maintenance therapy. The drug is being developed by Sanofi (SNY) and is not yet approved by regulatory authorities.
The specific molecular target of CellProtect has not been disclosed in available information. It is classified as a small molecule modality, but its mechanism of action is not publicly detailed. The drug is being investigated for its potential role in Multiple Myeloma maintenance therapy.
CellProtect is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Multiple Myeloma.
CellProtect is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not received FDA approval and is still being studied in clinical trials. The ongoing Phase 2 trial is actively recruiting participants with Multiple Myeloma.
CellProtect is being evaluated in one active Phase 2 clinical trial with the identifier NCT04558931. This trial, titled 'Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma,' is recruiting 62 participants in Sweden. The study is randomized and active-controlled.
No, CellProtect is not the same as isatuximab. The clinical trial NCT04558931 is studying autologous NK cells alone or in combination with isatuximab as maintenance therapy for Multiple Myeloma. CellProtect is a separate investigational small molecule being developed by Sanofi.