SIRPant-M (SI-101)

P1, N=24, Recruiting, SIRPant Immunotherapeutics, Inc. | Trial completion date: Mar 2025 --> Dec 2025 | Trial primary completion date: Mar 2025 --> Jun 2025

P1, N=24, Recruiting, SIRPant Immunotherapeutics, Inc. | Not yet recruiting --> Recruiting

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.

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, N=24, Not yet recruiting, SIRPant Immunotherapeutics, Inc.

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

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