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    DRUG:

    CLN-978

    i
    Other names: CLN-978
    Company:
    Cullinan Therap
    Drug class:
    CD3 agonist, CD19 inhibitor
    Related drugs:
    14d
    A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1, N=24, Recruiting, Cullinan Therapeutics Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CLN-978
    3ms
    A Study of CLN-978, a CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, Cullinan Therapeutics Inc.
    New P1 trial
    |
    CLN-978
    8ms
    A Study of CLN-978 in Patients With Relapsed or Refractory (R/R) B Cell Non-Hodgkin Lymphoma (B-NHL) (clinicaltrials.gov)
    P1, N=90, Active, not recruiting, Cullinan Therapeutics Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CLN-978
    1year
    Correction: CLN-978, a novel half-life extended CD19/CD3/HSA-specific T cell-engaging antibody construct with potent activity against B-cell malignancies with low CD19 expression. (PubMed, J Immunother Cancer)
    No abstract available
    Journal
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression • CD19 underexpression
    |
    CLN-978
    1year
    A Phase 1, Open-Label, Dose Escalation and Dose Expansion Study of CLN-978 (CD19XCD3XHSA) in Patients with Relapsed/Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (B-NHL) (ASH 2023)
    Approximately 90 patients (30 in dose escalation and 60 in dose expansion) will be enrolled at approximately 6 sites in the U.S., reflecting both community and academic centers. The study is currently enrolling (NCT05879744).
    Clinical • P1 data
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    CLN-978
    over1year
    CLN-978, a novel half-life extended CD19/CD3/HSA-specific T cell-engaging antibody construct with potent activity against B-cell malignancies with low CD19 expression. (PubMed, J Immunother Cancer)
    CLN-978 warrants further exploration. An ongoing clinical phase 1 trial is investigating safety, pharmacokinetics, pharmacodynamics, and the initial therapeutic potential of subcutaneously administered CLN-978 in patients with non-Hodgkin's lymphoma.
    Journal
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression • CD19 underexpression
    |
    CLN-978
    over1year
    A Study of CLN-978 in Patients With Relapsed or Refractory (R/R) B Cell Non-Hodgkin Lymphoma (B-NHL) (clinicaltrials.gov)
    P1, N=90, Recruiting, Cullinan Oncology, LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CLN-978
    over1year
    A Study of CLN-978 in Patients With Relapsed or Refractory (R/R) B Cell Non-Hodgkin Lymphoma (B-NHL) (clinicaltrials.gov)
    P1, N=90, Not yet recruiting, Cullinan Oncology, LLC
    New P1 trial
    |
    CLN-978
    almost3years
    Preclinical characterization of a next-generation CD19/CD3-bispecific T cell engager with extended serum half-life and superior potency against CD19-low target cells (AACR 2022)
    Both the CD19-specific T cell-engaging bispecific antibody blinatumomab and various autologous CAR-T cell therapies have exhibited robust clinical activity in relapsed/refractory acute lymphocytic leukemia (ALL) and non-Hodgkin lymphoma (NHL). The cross-reactivity of CLN-978 to the NHP orthologs of CD19, CD3 and albumin enables assessment of depletion of normal B cells, strategies to mitigate cytokine release, PK and PD properties, and exploration of dosing routes. CLN-978 holds promise as a CD19-targeted therapeutic that can be easily and conveniently administered to patients with diverse B cell malignancies.
    Preclinical
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    Blincyto (blinatumomab) • CLN-978