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- ||| SAR443579 / Sanofi
Enrollment change, Trial completion date: TCD17197: First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (clinicaltrials.gov) - Oct 1, 2024
P1/2, N=169, Recruiting, Sponsor: Sanofi
N=126 --> 169 | Trial completion date: Nov 2026 --> Oct 2030
- || SAR443579 / Sanofi
New P1/2 trial: A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies (clinicaltrials.gov) - Jul 17, 2024
P1/2, N=18, Recruiting, Sponsor: Sanofi
- IPH6501 / Innate
A phase 1/2, open-label, multicenter trial investigating the safety, tolerability, and preliminary antineoplastic activity of IPH6501, a first-in-class NK cell engager, in patients with relapsed and/or refractory CD20-expressing non-Hodgkin lymphoma. (Hall A; Poster Bd #: 72a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2430;
P1/2
The Phase 2 part will enroll one or more cohorts of selected B-cell NHL subtypes to be determined at a later stage. Up to 184 subjects will be enrolled, and the study is open in the United States, Australia and Europe.
- IPH6501 / Innate
Preclinical assessment of IPH6501, a first-in-class IL2v-armed tetraspecific NK cell engager directed against CD20 for R/R B-NHL, in comparison with a CD20-targeting T cell engager. (Hall A; Poster Bd #: 13) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2367;
The preclinical demonstrations of IPH6501 activities across various in vivo models and its effectiveness in ex vivo assays using cells from R/R B-NHL patients provide compelling evidence of its therapeutic potential and tolerability. IPH6501 is emerging as a promising new candidate within the treatment landscape for R/R B-NHL and is currently being investigated in a global, first-in-human phase 1/2 study (NCT 06088654).
- SAR443579 / Sanofi, Innate
First-in-Human Study of the CD123 NK Cell Engager SAR443579 in Relapsed or Refractory Acute Myeloid Leukemia, B-Cell Acute Lymphoblastic Leukemia or High Risk-Myelodysplasia: Updated Safety,... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4419;
P1/2
IPH6501 is emerging as a promising new candidate within the treatment landscape for R/R B-NHL and is currently being investigated in a global, first-in-human phase 1/2 study (NCT 06088654). Pts had received a median of 2.0 (1.0
- ||| SAR443579 / Sanofi
Enrollment change: TCD17197: First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (clinicaltrials.gov) - Oct 5, 2023
P1/2, N=126, Recruiting, Sponsor: Sanofi
Pts had received a median of 2.0 (1.0 N=82 --> 126
- SAR443579 / Sanofi, Innate
Effects of SAR443579, a trifunctional anti-CD123 NK cell engager (NKCE), on natural killer (NK) cell subsets at the single cell level (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1302;
6 Finally, we confirmed our findings at the protein level using flow cytometry and Meso-Scale Discovery (MSD) analyses. Conclusions Together, our work characterized peripheral blood NK cell compartments and explained the NK changes induced by SAR443579 in the presence of target cells at Single-Cell RNA and protein levels.
- SAR443579 / Sanofi, Innate
A noval mouse model for preclinical efficacy of the antibodies associated with the target CD16A (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_843;
Conclusions Together, our work characterized peripheral blood NK cell compartments and explained the NK changes induced by SAR443579 in the presence of target cells at Single-Cell RNA and protein levels. Background FDA has granted Fast Track Designation for SAR
- ||||| SAR443579 / Sanofi, Innate
Clinical: 🚨Abstract presented by @AMLHub summarizes the preliminary 🦺& efficacy results from the P I/II trial investigating SAR443579 in patients with relapsed/refractory AML Read➡️ https://t.co/NgejNDk9lY #bloodcancer @AcuteMyeloid @LeukemiaRF @Daver_Leukemia @RABCnow @BloodCancerA (Twitter) - Jul 29, 2023
- SAR443579 / Sanofi, Innate
Preliminary pharmacokinetics (PK) and pharmacodynamic (PD) analysis of the CD123 NK cell engager (NKCE) SAR443579 in patients (pts) with relapsed or refractory acute myeloid leukemia (R/R AML), B cell acute lymphoblastic leukemia (B-ALL) or high risk-myelodysplasia (HR-MDS) (Toledo Auditorium - Hall 3) - Jul 27, 2023 - Abstract #ESMO2023ESMO_1060;
P1/2
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.
- ||||| SAR443579 / Sanofi, Innate
📢 ASCO 2023 Acute Myeloid Leukemia 📢 ➡️ What were the dose levels explored, and were there any dose-limiting #Toxicities observed, and the most common #TEAEs and their frequencies reported in #AML? @A_Stein_AHC @CityofHope #SAR443579 #ASCO23 🔗 https://t.co/84s7IN6irg (Twitter) - Jun 14, 2023
- ||||| SAR443579 / Sanofi, Innate
Clinical, P1/2 data: Congress | #EHA2023 | Poster @A_Stein_AHC @cityofhope presents preliminary safety and efficacy data of SAR443579 from a phase I/II trial in patients with R/R AML. SAR443579 was well tolerated up to doses of 3000µg/kg QW, with clinical benefit in patients with R/R AML. #leusm (Twitter) - Jun 10, 2023
- SAR443579 / Sanofi, Innate
A FIRST-IN-HUMAN STUDY OF CD123 NK CELL ENGAGER SAR443579 IN RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA, B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA OR HIGH RISK-MYELODYSPLASIA (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_2132;
P1/2
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
- SAR443579 / Sanofi, Innate
A first-in-human study of CD123 NK cell engager SAR443579 in relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia, or high-risk myelodysplasia. (Available On Demand) - Apr 26, 2023 - Abstract #ASCO2023ASCO_790;
P1/2
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
- | SAR443579 / Sanofi, Innate, monalizumab (IPH2201) / AstraZeneca, Innate
$IPH $IPHA Publication hier des titres des abstracts de l'#ASCO2023 (2-6 juin, Chicago). Plusieurs concernent des produits #InnatePharma: Monalizumab (NEOCOAST-2 et PACIFIC-9) et IPH6101 (Twitter) - Apr 26, 2023
- || SAR443579 / Sanofi
Trial completion date, Trial primary completion date: TCD17197: First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (clinicaltrials.gov) - Apr 18, 2023
P1/2, N=82, Recruiting, Sponsor: Sanofi
SAR Trial completion date: Aug 2025 --> Jan 2027 | Trial primary completion date: Jun 2024 --> Feb 2026
- | SAR443579 / Sanofi
Trial completion date: TCD17197: First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (clinicaltrials.gov) - Jan 5, 2023
P1/2, N=82, Recruiting, Sponsor: Sanofi
Trial completion date: Aug 2025 --> Jan 2027 | Trial primary completion date: Jun 2024 --> Feb 2026 Trial completion date: Apr 2026 --> Aug 2025
- SAR443579 / Sanofi, Innate
An Open-Label, First-in-Human, Dose-Escalation Study of SAR443579 Administered As Single Agent By Intravenous Infusion in Patients with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-Cell Acute Lymphoblastic Leukemia (B-ALL) or High-Risk Myelodysplasia (HR-MDS) (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_4710;
P1/2
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
- | SAR443579 / Sanofi
Trial completion date: TCD17197: First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (clinicaltrials.gov) - Aug 31, 2022
P1/2, N=82, Recruiting, Sponsor: Sanofi
Recruitment is ongoing and this trial is registered on clinicaltrials.gov: NCT05086315 Trial completion date: Nov 2027 --> Apr 2026
- || SAR443579 / Sanofi
Trial completion date, Trial primary completion date: TCD17197: First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (clinicaltrials.gov) - Jun 22, 2022
P1/2, N=82, Recruiting, Sponsor: Sanofi
Trial completion date: Nov 2027 --> Apr 2026 Trial completion date: Jul 2029 --> Nov 2027 | Trial primary completion date: Oct 2026 --> Jun 2024
- ||| SAR443579 / Sanofi
Enrollment open, Trial completion date: TCD17197: First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (clinicaltrials.gov) - Feb 4, 2022
P1/2, N=82, Recruiting, Sponsor: Sanofi
Trial completion date: Jul 2029 --> Nov 2027 | Trial primary completion date: Oct 2026 --> Jun 2024 Not yet recruiting --> Recruiting | Trial completion date: Jan 2032 --> Jul 2029
- |||| SAR443579 / Sanofi
New P1/2 trial: TCD17197: First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (clinicaltrials.gov) - Oct 19, 2021
P1/2, N=82, Not yet recruiting, Sponsor: Sanofi