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    DRUG:

    GB261

    i
    Other names: GB261
    Associations

    News

    Trials
    Company:
    Walvax
    Drug class:
    CD20 inhibitor, CD3 agonist
    Related drugs:
    Associations

    News

    Trials
    6ms
    GB261, an Fc-Function Enabled and CD3 Affinity De-Tuned CD20/CD3 Bispecific Antibody, Demonstrated a Highly Advantageous Safety/Efficacy Balance in an Ongoing First-in-Human Dose-Escalation Study in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (ASH 2023)
    At 100mg dose, there were 5 evaluable patients, with ORR 100% (5/5), CRR 80% (4/5) and PR (20%, 1/5; mosunetuzumab-refractory rrDLBCL patient)...All cases of CRS were grade 1 (8.5%, 4/47) or 2 (4.3%, 2/47), no grade 3 (Lee et al., ASTCT criteria), no interruptions of treatment, and no administration of Tocilizumab... GB261, a novel and highly differentiated CD20/CD3 bispecific antibody, is the first clinical stage Fc+ CD20/CD3 T cell engager. In heavily pretreated B-NHL patients, GB261 showed a highly advantageous safety/efficacy balance, consistent with the MOA. The safety profile is excellent especially for the CRS which is very mild, transient and less frequent compare with other CD20/CD3 bispecific antibodies.
    Clinical • P1 data
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Actemra IV (tocilizumab) • Lunsumio (mosunetuzumab-axgb) • GB261
    over2years
    A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL. (clinicaltrials.gov)
    P1/2, N=460, Recruiting, Genor Biopharma Co., Ltd. | Not yet recruiting --> Recruiting | Initiation date: Jun 2022 --> Aug 2021
    Clinical • Enrollment open • Trial initiation date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    GB261
    over2years
    A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL. (clinicaltrials.gov)
    P1/2, N=460, Not yet recruiting, Genor Biopharma Co., Ltd. | Initiation date: Jun 2021 --> Jun 2022
    Clinical • Trial initiation date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    GB261
    almost3years
    A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL. (clinicaltrials.gov)
    P1/2, N=460, Not yet recruiting, Genor Biopharma Co., Ltd.
    Clinical • New P1/2 trial
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    GB261