Pts had received a median of 2.0 (1.0 –10.0) prior lines of treatment with 13 pts (30.2%) reporting prior hematopoietic stem cell transplantation and 36 pts (83.7%) with prior exposure to venetoclax. SAR'579 was well tolerated up to doses of 6000 µg/kg QW with observed clinical benefit in pts with R/R AML. The results are consistent with the predicted favorable safety profile.
Observed peak cytokine levels did not show significant dose-related increase and no association between elevated peak cytokine levels and clinical responses. The results are consistent with the improved safety profile compared to CD123-targeted T-cell engagers.
The median age was 70 years (range: 21 - 80) with 9 patients (39.1%) reporting prior hematopoietic stem cell transplantation (HSCT) and 16 (69.6%) had prior exposure to venetoclax. SAR’579 was well tolerated up to doses of 3000 µg/kg QW with observed clinical benefit in patients with R/R AML. The trial continues to accrue patients.
over 1 year ago
P1 data
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CD123 (Interleukin 3 Receptor Subunit Alpha) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
The median age was 70 years (range: 21 - 80) with 9 patients (39.1%) reporting prior hematopoietic stem cell transplantation (HSCT) and 16 (69.6%) had prior exposure to venetoclax. SAR’579 was well tolerated up to doses of 3000 µg/kg QW with observed clinical benefit in patients with R/R AML. The trial continues to accrue patients. Clinical trial information: NCT05086315.
over 1 year ago
P1 data
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CD123 (Interleukin 3 Receptor Subunit Alpha) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
Patients with white blood cell count ≥15000/mm3 are excluded and use of hydroxyurea should be discontinued at least 1 day before first planned IMP administration. This study will be conducted in Australia, France, the Netherlands, and the United States. Recruitment is ongoing and this trial is registered on clinicaltrials.gov: NCT05086315
2 years ago
Clinical • P1 data
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CD123 (Interleukin 3 Receptor Subunit Alpha) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)