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DRUG:

SIRPant-M (SI-101)

i
Other names: SI-101
Associations
Company:
SIRPant Immunotherap
Drug class:
Immunomodulator, Macrophage stimulant
Related drugs:
Associations
11ms
Study of SIRPant-M in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov)
P1, N=24, Recruiting, SIRPant Immunotherapeutics, Inc. | Not yet recruiting --> Recruiting
Enrollment open
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SIRPA (Signal Regulatory Protein Alpha)
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SIRPant-M (SI-101)
1year
SMART101 Donor T-Lymphoid Progenitors to Accelerate Immune Reconstitution Post-Haploidentical Peripheral Blood Stem Cell Transplantation with Post-Transplant Cyclophosphamide: SI101-02 First-in-Human Phase I/II (ASH 2023)
Conclusion SMART101 is the first-generation of allogeneic TLP cell therapy obtained from Smart Immune's proprietary GMP manufacturing platform. The duration and the depth of T cell immunodeficiency post haplo PTCy HSCT is expected to be significantly reduced by the infusion of SMART101 thereby decreasing the non-relapse mortality and morbidity rates and thus improving the overall clinical outcome of this therapy.
P1/2 data • Post-transplantation
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CD34 (CD34 molecule) • CD7 (CD7 Molecule)
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cyclophosphamide • SIRPant-M (SI-101) • SMART 101
1year
Phase 1 Study of Autologous Sirpα-Low Macrophages (SIRPant-M) Administered By Intratumoral Injection Alone or in Combination with External-Beam Radiotherapy in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma (NCT05967416) (ASH 2023)
Tumor response, including abscopal response, is evaluated by Lugano criteria or other Workgroup criteria as appropriate for the tumor type at the end of the DLT-period (Day 30), Week 12 and per SOC thereafter. Serial blood samples and a tumor biopsy before and 16 days after treatment are collected for multi-parameter analyte detection including pro-inflammatory cytokines, multiplex flow cytometry, scRNA sequencing, and ctDNA analysis to investigate pharmacodynamics and mechanism of action.
Clinical • P1 data • Combination therapy
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SIRPA (Signal Regulatory Protein Alpha)
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SIRPant-M (SI-101)
over1year
New P1 trial • Combination therapy
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SIRPA (Signal Regulatory Protein Alpha)
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SIRPant-M (SI-101)
over1year
SI101-01 PHASE I/II STUDY EVALUATING SAFETY AND EFFICACY OF ALLOGENEIC SMART101 T-LYMPHOID PROGENITOR INJECTION TO ACCELERATE IMMUNE RECONSTITUTION AFTER T-CELL DEPLETED ALLOGENEIC HSCT (EHA 2023)
SMART101 is the first-generation of allogeneic T lymphoid progenitor cells obtained through Smart Immune's ProTcell platform, the first scalable progenitor T-cell manufacturing system in clinics. The early data indicate that SMART101 is well tolerated with a good safety profile. Thymic function, Post-transplant, CD4+ T cells, Allogeneic hematopoietic stem cell transplant
Clinical • P1/2 data
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CXCR4 (Chemokine (C-X-C motif) receptor 4) • CD34 (CD34 molecule) • CD7 (CD7 Molecule) • MLANA (Melan-A) • KLRB1 (Killer Cell Lectin Like Receptor B1)
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SIRPant-M (SI-101) • SMART 101
over1year
SMART101 DONOR T-LYMPHOID PROGENITORS TO ACCELERATE IMMUNE RECONSTITUTION POST-HAPLOIDENTICAL PERIPHERAL BLOOD STEM CELL TRANSPLANTATION WITH POST-TRANSPLANT CYCLOPHOSPHAMIDE: SI101-02 PHASE I/II (EHA 2023)
SMART101 is the first-generation of allogeneic T lymphoid progenitor cell therapy obtained from Smart Immune's proprietary ProTcell platform, the first scalable progenitor T-cell manufacturing system in clinics. Notch, Thymus, Post-transplant, Allogeneic hematopoietic stem cell transplant
P1/2 data • Post-transplantation
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CXCR4 (Chemokine (C-X-C motif) receptor 4) • CD34 (CD34 molecule) • CD7 (CD7 Molecule) • MLANA (Melan-A) • KLRB1 (Killer Cell Lectin Like Receptor B1) • SELP (Selectin P)
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cyclophosphamide • SIRPant-M (SI-101) • SMART 101