AZD0120 / AstraZeneca 
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  • ||||||||||  AZD0120 / AstraZeneca
    Journal:  B-Cell Maturation Antigen/CD19 Dual-Targeting Immunotherapy in Newly Diagnosed Multiple Myeloma. (Pubmed Central) -  Sep 20, 2024   
    The findings of this single-arm, open-label phase 1 cohort study suggest that GC012F may be a safe treatment associated with positive health and survival outcomes for patients with high-risk NDMM eligible for transplant. Owing to the small sample size, further studies with larger cohorts and longer follow-up durations are needed.
  • ||||||||||  AZD0120 / AstraZeneca
    Enrollment open:  Study of FasT CAR-T GC012F Injection NDMM Patients (clinicaltrials.gov) -  Feb 13, 2024   
    P1,  N=18, Recruiting, 
    Clinical trial information: ChiCTR2100047061. Not yet recruiting --> Recruiting
  • ||||||||||  GC012F / Gracell
    FIRST-IN-HUMAN STUDY OF CD19/BCMA DUAL-TARGETING FAST CAR-T GC012F FOR PATIENTS WITH RELAPSED/REFRACTORY B-CELL NON-HODGKIN'S LYMPHOMA () -  May 13, 2022 - Abstract #EHA2022EHA_1043;    
    All three pts achieved CR by PET-CT at day 28 after GC012F infusion, and response is ongoing at 3-months follow-up in the two assessable patients. Conclusion The preliminary safety and tolerability of GC012F in r/r B-NHL at three different dose levels ranging from 3.7*10 4 CAR-T/kg-3*10 5 CAR-T/kg showed promising early and potent activity in r/r B-NHL pts with 100% CR rate at 1-month which was maintained in pts that were available to be assessed at the 3-month visit including r/r DLBCL pts and pts with bulky disease whose treatment is often challenging. Additional pts and longer follow up are needed to further evaluate these promising early results of GC012F in r/r B-NHL and to determine the RP2D for phase 2.
  • ||||||||||  GC012 / Gracell, Zarzio (filgrastim biosimilar) / Novartis
    [VIRTUAL] LONG-TERM FOLLOW-UP RESULTS OF A MULTICENTER FIRST-IN-HUMAN STUDY OF THE DUAL BCMA/CD19 TARGETED FAST CAR-T GC012F FOR PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA () -  May 13, 2021 - Abstract #EHA2021EHA_404;    
    P1
    At data cut off, the median time to follow up was 13.8 mths (6.1-16.4) – with the median duration of response not yet reached. Cytokine Release Syndrome (CRS) and ICANs were graded by ASBMTcriteria: grade 1-2 n=16 (84.2%), grade 3 n=2 (10.5%). Median duration of CRS was 4d (1-8d). No grade 4/5 CRS or Immunce effector cell-associated Neurotoxicity syndrome (ICANS) were observed. 2 deaths occurred on study and were assessed as not related to therapy – one reported previously; one patient was diagnosed with& Conclusion BCMA-CD19 dual FasT CAR-T GC012F showed early, deep and durable responses with a high ORR (94.7%; VGPR or better) including a high MRD negative sCR rate (DL3=100%, n=9) in high risk RRMM pts including those refractory to anti-CD38, PI and IMIDs with a favorable safety profile consistent with previous findings. BCMA-CD19 dual FasT CAR-T GC012F may present a new treatment approach for patients with RRMM including those with high-risk features refractory to standard of care.