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    DRUG:

    rondecabtagene autoleucel (LYL314)

    i
    Other names: LYL314, IMPT-314, IMPT314, IMPT 314, LYL-314, ronde-cel
    Company:
    Lyell Immunopharma
    Drug class:
    CD19-targeted CAR-T immunotherapy, CD20-targeted CAR-T immunotherapy
    Related drugs:
    2ms
    MPCT-012L: Study of LYL314 in Aggressive Large B-Cell Lymphoma (clinicaltrials.gov)
    P1/2, N=270, Recruiting, Lyell Immunopharma, Inc. | Trial completion date: Jan 2028 --> Jun 2031 | Trial primary completion date: Aug 2026 --> Dec 2028
    Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    cyclophosphamide • fludarabine IV • rondecabtagene autoleucel (LYL314)
    2ms
    PiNACLE-H2H: A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy (clinicaltrials.gov)
    P3, N=400, Not yet recruiting, Lyell Immunopharma, Inc.
    New P3 trial
    |
    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • rondecabtagene autoleucel (LYL314)
    8ms
    MPCT-012L: Study of LYL314 in Aggressive Large B-Cell Lymphoma (clinicaltrials.gov)
    P1/2, N=270, Recruiting, Lyell Immunopharma, Inc. | N=150 --> 270 | Trial completion date: Dec 2029 --> Jan 2028 | Trial primary completion date: Jun 2025 --> Aug 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    cyclophosphamide • fludarabine IV • rondecabtagene autoleucel (LYL314)
    over1year
    MPCT-012L: Study of IMPT-314 in R/R Aggressive B-cell NHL (clinicaltrials.gov)
    P1/2, N=150, Recruiting, ImmPACT Bio | N=100 --> 150
    Enrollment change
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    rondecabtagene autoleucel (LYL314)
    2years
    A CD19/CD20-Directed Bispecific CAR-T Cell Therapy in Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma (NHL) (ASH 2023)
    The primary objective of Phase 2 is to estimate the efficacy of IMPT-314 as measured by CR rate. Secondary endpoints include evaluation of pharmacokinetics and time to event outcomes.
    CAR T-Cell Therapy • IO biomarker
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8)
    |
    CD19 expression
    |
    rondecabtagene autoleucel (LYL314)
    2years
    Study of IMPT-314 in R/R Aggressive B-cell (clinicaltrials.gov)
    P1/2, N=100, Recruiting, ImmPACT Bio | N=50 --> 100
    Enrollment change
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    rondecabtagene autoleucel (LYL314)
    over2years
    Study of IMPT-314 in R/R Aggressive B-cell (clinicaltrials.gov)
    P1/2, N=50, Recruiting, ImmPACT Bio | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    rondecabtagene autoleucel (LYL314)
    over2years
    Study of IMPT-314 in R/R Aggressive B-cell (clinicaltrials.gov)
    P1/2, N=50, Not yet recruiting, ImmPACT Bio
    New P1/2 trial
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    rondecabtagene autoleucel (LYL314)