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    DRUG:

    AFM13/AB-101

    i
    Other names: AFM13/AB-101
    Company:
    Affimed, GC Biopharma
    Drug class:
    NK cell stimulant, CD16A agonist, CD30 inhibitor
    Related drugs:
    1year
    AFM13 in Combination with Allogeneic Natural Killer Cells (AB-101) in Relapsed or Refractory Hodgkin Lymphoma and CD30+ Peripheral T-Cell Lymphoma: A Phase 2 Study (LuminICE) (ASH 2023)
    AB-101 has demonstrated potent killing of tumor cell lines in vitro and in vivo, and preliminary results of a Phase 1/2 trial of AB-101 alone and in combination with rituximab in patients with R/R B cell non-Hodgkin lymphoma demonstrated AB-101 is well tolerated (Khanal et al...Patients aged ≥18 years are planned for enrolment and patients with R/R HL must have received at least two prior lines of therapy including prior combination chemotherapy, brentuximab vedotin (BV) and a checkpoint inhibitor...A run-in phase will assess two dose levels of AFM13 and AB-101 in 4 cohorts (Figure). A standard lymphodepletion regimen of fludarabine (30 mg/m2/day) and cyclophosphamide (300 mg/m2/day) will be administered IV from Day −5 to Day −3 at the start of each treatment cycle...In addition, an exploratory cohort (cohort 5) will begin enrolment of patients with CD30+ PTCL. Disease and efficacy assessments will be conducted at screening and on Day 43 (± 3 days) of each cycle.
    P2 data • Combination therapy
    |
    ALK (Anaplastic lymphoma kinase) • TNFRSF8 (TNF Receptor Superfamily Member 8) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
    |
    ALK positive • TNFRSF8 expression
    |
    Rituxan (rituximab) • cyclophosphamide • Adcetris (brentuximab vedotin) • fludarabine IV • acimtamig (AFM13) • AFM13/AB-101 • AlloNK (GCC4001)
    1year
    LuminICE-203: Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL (clinicaltrials.gov)
    P2, N=154, Recruiting, Affimed GmbH | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    ALK (Anaplastic lymphoma kinase) • TNFRSF8 (TNF Receptor Superfamily Member 8)
    |
    ALK positive • TNFRSF8 positive • ALK negative
    |
    cyclophosphamide • fludarabine IV • acimtamig (AFM13) • AFM13/AB-101 • AlloNK (GCC4001)
    over1year
    LuminICE-203: Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL (clinicaltrials.gov)
    P2, N=154, Not yet recruiting, Affimed GmbH
    New P2 trial • Combination therapy
    |
    ALK (Anaplastic lymphoma kinase) • TNFRSF8 (TNF Receptor Superfamily Member 8)
    |
    ALK positive • TNFRSF8 positive • ALK negative
    |
    cyclophosphamide • fludarabine IV • acimtamig (AFM13) • AFM13/AB-101 • AlloNK (GCC4001)