Drug intelligence / Profile preview

FT516 + obinutuzumab

Development stage
Unknown
Lead developer
Fate Therapeutics
Modality
CAR-NK Cells → Other Engineered Cells → Adoptive Cell Transfer → Cell Therapies, Monoclonal Antibodies → Antibody-Based Therapeutics, Lymphokine-Activated Killer Cells → Native Immune Cells → Adoptive Cell Transfer → Cell Therapies
Administration
Intravenous
01

Overview

FT516 + obinutuzumab is an investigational combination therapy for relapsed/refractory B-cell lymphoma and other advanced hematologic malignancies. **FT516** is an off-the-shelf, allogeneic NK cell therapy derived from a clonal master engineered induced pluripotent stem cell (iPSC) line, engineered to express a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor that maximizes antibody-dependent cellular cytotoxicity (ADCC) when paired with anti-CD20 monoclonal antibodies. **Obinutuzumab** is a glycoengineered, humanized monoclonal antibody targeting CD20 on B cells; it exerts its effects mainly through enhanced ADCC, direct lysosome-dependent cell death, and reduced complement-dependent cytotoxicity compared to other anti-CD20 mAbs. The combination aims to augment B-cell malignancy killing by leveraging FT516’s optimized NK cell cytotoxicity with obinutuzumab’s potent CD20-targeted immune effector recruitment and direct B-cell death mechanisms. This regimen is under clinical investigation in Phase I trials for adult patients with relapsed/refractory B-cell lymphoma who may have failed prior therapies including CAR T-cell therapy[1][5][7].

Other names
FT516FT-516FT 516obinutuzumab
02

Targets

FCGR3A (Low affinity immunoglobulin gamma Fc region receptor III-A)CD20 (B-lymphocyte antigen CD20)

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