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    DRUG:

    Talvey (talquetamab-tgvs)

    i
    Other names: JNJ-64407564, JNJ 64407564, JNJ-7564 , JNJ64407564, JNJ7564, JNJ 7564
    Company:
    Genmab, J&J
    Drug class:
    CD3 agonist, GPRC5D inhibitor
    Related drugs:
    2d
    A Study of Talquetamab for People With Multiple Myeloma Who Have Received BCMA CAR T-Cell Therapy (clinicaltrials.gov)
    P2, N=17, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Oct 2026 --> Oct 2027 | Trial primary completion date: Oct 2026 --> Oct 2027
    Trial completion date • Trial primary completion date
    |
    Talvey (talquetamab-tgvs)
    2d
    KarMMa-2: An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma (clinicaltrials.gov)
    P2, N=312, Completed, Celgene | Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Jan 2026 | Trial primary completion date: Oct 2025 --> Jan 2026
    Trial completion • Trial completion date • Trial primary completion date
    |
    lenalidomide • Abecma (idecabtagene vicleucel) • Talvey (talquetamab-tgvs)
    3d
    MMulti-Immune HR; Multi-Target Immunotherapy for High-Risk Multiple Myeloma (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, University of Arkansas | Initiation date: Apr 2026 --> Jul 2026
    Trial initiation date
    |
    clonoSEQ
    |
    lenalidomide • Darzalex (daratumumab) • melphalan • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
    17d
    EMN37: Study for frail patients with newly diagnosed multiple myeloma treated with Daratumumab in combination with Teclistamab and Talquetamab. (2024-520433-76-00)
    P1/2, N=150, Recruiting, European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale
    New P1/2 trial
    |
    Darzalex (daratumumab) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
    21d
    Talisman: A Study to Evaluate Preventive Treatments for Talquetamab-related Oral Toxicity (clinicaltrials.gov)
    P2, N=130, Recruiting, Janssen Research & Development, LLC | Trial completion date: Oct 2027 --> Apr 2029
    Trial completion date
    |
    Talvey (talquetamab-tgvs)
    21d
    MonumenTAL-8: A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma (clinicaltrials.gov)
    P2, N=11, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Nov 2026 --> Aug 2027
    Trial completion date
    |
    Carvykti (ciltacabtagene autoleucel) • Talvey (talquetamab-tgvs)
    21d
    MonumenTAL-1: Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=279, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Mar 2029 --> Oct 2027
    Trial completion date • First-in-human
    |
    Talvey (talquetamab-tgvs)
    1m
    CREATT: Multi-center, Observational Study of Teclistamab or Talquetamab in The Treatment of Multiple Myeloma Patients in China (ChiCTR2500112479)
    P4, N=200, Not yet recruiting, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
    New P4 trial
    |
    Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
    2ms
    OPTec: Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma (clinicaltrials.gov)
    P2, N=100, Recruiting, SCRI Development Innovations, LLC | N=75 --> 100
    Enrollment change
    |
    CD4 (CD4 Molecule)
    |
    Actemra IV (tocilizumab) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
    2ms
    Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=31, Recruiting, Medical College of Wisconsin | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Carvykti (ciltacabtagene autoleucel) • Talvey (talquetamab-tgvs)
    2ms
    GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5 (clinicaltrials.gov)
    P2, N=160, Recruiting, University of Heidelberg Medical Center | Trial completion date: Aug 2028 --> Sep 2029 | Trial primary completion date: Feb 2027 --> Sep 2028
    Trial completion date • Trial primary completion date
    |
    lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • JNJ-5322 • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
    3ms
    Immune Effector Cell-Associated HLH-Like Syndrome (IEC-HS) in CAR-T and TCE-Treated Myeloma and B-Cell Malignancies: Insights from a Pharmacovigilance Study. (PubMed, Transplant Cell Ther)
    IEC-HS is a rare but potentially fatal complication. Our disproportionality analysis identifies significant reporting signals for tisa-cel and cilta-cel. The high absolute number of cases observed for products like axi-cel appears to reflect high utilization rather than a disproportionate risk, underscoring the necessity of using statistical signal detection methods when interpreting spontaneous reports.
    Journal • Adverse events
    |
    ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
    |
    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • Epkinly (epcoritamab-bysp) • Elrexfio (elranatamab-bcmm) • Tecartus (brexucabtagene autoleucel) • Abecma (idecabtagene vicleucel) • Carvykti (ciltacabtagene autoleucel) • Lunsumio (mosunetuzumab-axgb) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv) • Columvi (glofitamab-gxbm)