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DRUG:

isatuximab subcutaneous (SAR650984 SC)

i
Other names: SAR650984 SC, Sarclisa subcutaneous
Associations
Trials
Company:
Sanofi
Drug class:
CD38 inhibitor, Apoptosis inducer
Associations
Trials
2ms
Trial primary completion date
|
lenalidomide • bortezomib • dexamethasone • isatuximab subcutaneous (SAR650984 SC)
3ms
Phase classification
|
isatuximab subcutaneous (SAR650984 SC)
3ms
Trial initiation date • Combination therapy
|
carfilzomib • isatuximab subcutaneous (SAR650984 SC)
5ms
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM (clinicaltrials.gov)
P3, N=534, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting | Trial primary completion date: May 2024 --> Nov 2024
Enrollment closed • Trial primary completion date • Combination therapy
|
dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc) • isatuximab subcutaneous (SAR650984 SC)
6ms
Enrollment closed • Combination therapy
|
carfilzomib • dexamethasone • dexamethasone injection • isatuximab subcutaneous (SAR650984 SC)
6ms
Enrollment closed
|
lenalidomide • bortezomib • dexamethasone • isatuximab subcutaneous (SAR650984 SC)
7ms
Trial completion • Combination therapy
|
pomalidomide • Sarclisa (isatuximab-irfc) • isatuximab subcutaneous (SAR650984 SC)
7ms
New P2 trial • Combination therapy
|
carfilzomib • dexamethasone • isatuximab subcutaneous (SAR650984 SC)
9ms
Phase classification • Combination therapy
|
pomalidomide • Sarclisa (isatuximab-irfc) • isatuximab subcutaneous (SAR650984 SC)
12ms
Multicenter Phase 2 Study of Subcutaneous Isatuximab Plus Bortezomib, Lenalidomide and Dexamethasone in the Treatment of Newly Diagnosed Transplant Ineligible Multiple Myeloma (clinicaltrials.gov)
P=N/A, N=74, Recruiting, Poitiers University Hospital | Not yet recruiting --> Recruiting | Initiation date: Jul 2023 --> Oct 2023
Enrollment open • Trial initiation date
|
lenalidomide • bortezomib • dexamethasone • isatuximab subcutaneous (SAR650984 SC)
1year
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM (clinicaltrials.gov)
P3, N=534, Recruiting, Sanofi | Trial completion date: Oct 2026 --> Feb 2027
Trial completion date • Combination therapy
|
Chr t(14;16)
|
dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc) • isatuximab subcutaneous (SAR650984 SC)
1year
CD38KO/CD38-CAR Human Primary Natural Killer Cells Enhance Cytotoxicity Against CD38-Expressing Primary Lymphoma, Leukemia, and Myeloma (ASH 2023)
FDA approved CD38 monoclonal antibodies (mAb) daratumumab and isatuximab are used to treat MM in patients, and have been tested to treat other CD38 expressing malignancies...Here, we generated multiple CD38 scFv based on isatuximab sequences and generated fratricide-resistant primary CD38-CAR NK cells using CRISPR/Cas9 genome editing and AAV6 gene delivery...Finally, we investigated the need for a CD38KO to develop a fratricide-resistant therapy by comparing the cytolytic and metabolic functions of CD38+/AAVS1KO and CD38KO CD38-CAR NK cells. We conclusively report a CD38-CAR NK cell therapy with enhanced metabolism and cytotoxicity toward a variety of hematologic malignancies, which can be further augmented by combination treatment with ATRA to target CD38-low malignancies.
IO biomarker
|
CD8 (cluster of differentiation 8) • CD38 (CD38 Molecule)
|
CD38 expression
|
Darzalex (daratumumab) • isatuximab subcutaneous (SAR650984 SC)
over1year
New trial
|
lenalidomide • bortezomib • dexamethasone • isatuximab subcutaneous (SAR650984 SC)
2years
Bone Marrow Immune Signatures in Multiple Myeloma Are Linked to Tumor Heterogeneity and Treatment Outcome (ASH 2022)
Anti-CD38 monoclonal antibodies increase efficacy when added to standard-of-care (SOC) regimens as reflected by minimal residual disease-negativity (MRD-neg) rates of >50 % after induction therapy in newly diagnosed MM (NDMM) patients treated with SOC plus isatuximab within the GMMG-HD7 trial (Goldschmidt et al...NDMM patients were treated with lenalidomide/bortezomib/dexamethasone (RVd) alone or in combination with isatuximab (isa-RVd, NCT03617731)...BME signatures at baseline and during treatment as defined by our reference atlas enable risk stratifications of MM patients and can identify patients at high risk for early relapse. Longitudinal monitoring of the BME can support clinical decision making, as a compromised CD8+ memory compartment in patients may impact on the efficacy of novel immunotherapies.
Clinical • IO biomarker
|
NRAS (Neuroblastoma RAS viral oncogene homolog) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
NRAS mutation
|
clonoSEQ
|
lenalidomide • bortezomib • dexamethasone • isatuximab subcutaneous (SAR650984 SC)
2years
Subcutaneous Isatuximab Administration By an on-Body Delivery System (OBDS) in Combination with Pomalidomide and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: Phase 1b Expansion Study Results (ASH 2022)
These updated results with longer follow-up of SC Isa administration via OBDS at the RP2D of 1400 mg showed a safety profile consistent with IV administration, with no IRs, excellent local tolerability and efficacy comparable to that observed in the phase 3 ICARIA study with IV Isa, in combination with Pd. Isa SC administration by OBDS is well tolerated, has a short duration of injection, and provides a convenient hands-free option with controlled delivery. Based on these results and OBDS performance, a non-inferiority phase 3 trial of Isa-SC with OBDS versus Isa-IV is ongoing (NCT05405166).
Clinical • P1 data • Combination therapy
|
CD38 (CD38 Molecule)
|
dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc) • isatuximab subcutaneous (SAR650984 SC)