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AB-101 + acimtamig
- Development stage
- Unknown
- Lead developer
- Affimed
- Modality
- Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, CAR-NK Cells → Other Engineered Cells → Adoptive Cell Transfer → Cell Therapies, Lymphokine-Activated Killer Cells → Native Immune Cells → Adoptive Cell Transfer → Cell Therapies
- Administration
- Intravenous
01
Overview
GCC4001 + AFM13 is a combination immunotherapy consisting of AB-101 (AlloNK), an allogeneic, cord blood-derived, cryopreserved naive NK cell therapy, and acimtamig (AFM13), a first-in-class tetravalent bispecific Innate Cell Engager (ICE). The regimen is designed to treat CD30-positive malignancies, such as relapsed or refractory classical Hodgkin lymphoma and peripheral T-cell lymphoma. AFM13 acts as a bridge, binding to CD30 on tumor cells and CD16A on the NK cells, thereby facilitating the targeted destruction of malignant cells through antibody-dependent cellular cytotoxicity (ADCC). The NK cells are activated with cytokines, expanded, and pre-complexed with AFM13 before infusion. The combination has received FDA Fast Track designation and is currently being evaluated in the Phase 2 LuminICE-203 clinical trial, demonstrating a favorable safety profile without reports of cytokine release syndrome, ICANS, or graft-versus-host disease.
- Other names
- GCC4001 + AFM13AB-101 + AFM13AlloNK + acimtamigAB-101 + acimtamig
02
Targets
CD30 (CD30 antigen)FCGR3A (Low affinity immunoglobulin gamma Fc region receptor III-A)
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