MDG1011

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Company:

Medigene

Drug class:

PRAME inhibitor

Related drugs:

over1year

TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms (clinicaltrials.gov)

P1/2, N=9, Terminated, Medigene AG | N=92 --> 9 | Trial completion date: Apr 2024 --> Jul 2022 | Recruiting --> Terminated | Trial primary completion date: Aug 2020 --> Jun 2022; The clinical trial is terminated after the completion of phase I without moving to Phase II.

over 1 year ago

Enrollment change • Trial completion date • Trial termination • Trial primary completion date

HLA-A (Major Histocompatibility Complex, Class I, A) • PRAME (Preferentially Expressed Antigen In Melanoma)

HLA-A*02:01 • HLA-A*02 • PRAME expression • HLA-A2 positive

MDG1011

almost2years

FIRST-IN-HUMAN STUDY OF MDG1011, A TCR-T CELL THERAPY DIRECTED AGAINST HLA-A*02:01-RESTRICTED PRAME, FOR HIGH-RISK MYELOID AND LYMPHOID NEOPLASMS (CD-TCR-001) (EBMT 2023)

Treatment was conducted with MDG1011 after lymphodepletion with fludarabine (25 mg/m² x 3d) and cyclophosphamide (300 mg/m² x 3d) in patients with HLA-A*02:01- and PRAME-positive r/r disease...Grade 1 cytokine release syndrome (CRS) occurred in 1 patient at DL2, grade 2 CRS in 1 patient at DL3 that was manageable with tocilizumab... In heavily pre-treated patients with advanced myeloid and lymphoid neoplasms, treatment with MDG1011 was generally safe and well tolerated up to 5x106 PRAME-specific TCR-T cells/kg. Clinical observations were corroborated by persistence of MDG1011 cells in PB and reductions in PRAME mRNA levels in PB and/or BM.

almost 2 years ago

P1 data

HLA-A (Major Histocompatibility Complex, Class I, A) • PRAME (Preferentially Expressed Antigen In Melanoma)

HLA-A*02 • PRAME expression

cyclophosphamide • fludarabine IV • Actemra IV (tocilizumab) • MDG1011