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    DRUG CLASS:

    CD3 agonist

    Related drugs:
    1d
    Clinical Study of A-319 in the Treatment of Active/Refractory Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1, N=9, Not yet recruiting, Wuhan Union Hospital, China
    New P1 trial
    |
    A-319
    1d
    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1, N=50, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Actemra IV (tocilizumab) • Lunsumio (mosunetuzumab-axgb)
    1d
    A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer (clinicaltrials.gov)
    P1, N=39, Completed, Janssen Research & Development, LLC | Recruiting --> Completed | N=90 --> 39 | Trial completion date: Mar 2025 --> Mar 2024 | Trial primary completion date: Mar 2025 --> Mar 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    5d
    Control of acute myeloid leukemia and generation of immune memory in vivo using AMV564, a bivalent bispecific CD33 x CD3 T cell engager. (PubMed, PLoS One)
    In addition to the anti-tumor effects of AMV564 on the clearance of MOLM13CG cells in vivo, similar effects were seen when primary CD33+ human AML cells were engrafted in NSG mice even when the human T cells made up only 2% of the peripheral blood cells and AML cells made up 98%. These studies suggest that AMV564 is a novel and effective bispecific diabody for the targeting of CD33+ AML that may provide long-term survival advantages in the clinic.
    Preclinical • Journal
    |
    CD8 (cluster of differentiation 8) • CD33 (CD33 Molecule) • CD4 (CD4 Molecule)
    |
    vixtimotamab (AMV564)
    5d
    Pembrolizumab and Blinatumomab in Treating Participants With Recurrent or Refractory Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P1/2, N=36, Recruiting, City of Hope Medical Center | Trial completion date: Apr 2024 --> Oct 2024 | Trial primary completion date: Apr 2024 --> Oct 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    CD19 positive
    |
    Keytruda (pembrolizumab) • Blincyto (blinatumomab)
    5d
    TNB585.001: A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov)
    P1, N=42, Active, not recruiting, Amgen | N=100 --> 42
    Enrollment change • Metastases
    5d
    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
    6d
    Decitabine, Venetoclax and Blinatumomab for Maintenance Following HSCT in Patients With Ph-Negative B-ALL (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, The First Affiliated Hospital of Soochow University
    New P2 trial
    |
    Venclexta (venetoclax) • Blincyto (blinatumomab) • decitabine
    6d
    Golden Gate Study: Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P3, N=287, Recruiting, Amgen | Trial completion date: Jan 2032 --> Sep 2031 | Trial primary completion date: Apr 2027 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Blincyto (blinatumomab)
    7d
    T cell characteristics impact response and resistance to T cell-redirecting bispecific antibodies in multiple myeloma. (PubMed, Clin Cancer Res)
    Primary resistance is characterized by a low T-cell/MM cell-ratio and Treg-driven immunosuppression, while reduced T-cell fitness due to continuous BsAb-mediated T-cell activation may contribute to development of acquired resistance.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • CD4 (CD4 Molecule)
    |
    Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
    7d
    MagnetisMM-20: A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=90, Recruiting, Pfizer | Trial primary completion date: Aug 2025 --> Feb 2026
    Trial primary completion date • Combination therapy
    |
    carfilzomib • Elrexfio (elranatamab-bcmm) • maplirpacept (TTI-622)
    7d
    Short-Term Linvoseltamab Treatment, on Top of Chronic Dupilumab Treatment, for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy (clinicaltrials.gov)
    P1, N=6, Recruiting, Regeneron Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Dupixent (dupilumab) • linvoseltamab (REGN5458)
    8d
    The CD33xCD123xCD70 Multispecific CD3-Engaging DARPin MP0533 Induces Selective T Cell-Mediated Killing of AML Leukemic Stem Cells. (PubMed, Cancer Immunol Res)
    These studies show that the multispecific-targeting strategy used with MP0533 holds promise for improved selectivity towards LSCs and efficacy against clonal heterogeneity, potentially bringing a new therapeutic option to this group of patients with high unmet need. MP0533 is currently being evaluated in a dose-escalation phase 1 study in patients with relapsed or refractory AML (NCT05673057).
    Journal
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • CD33 (CD33 Molecule) • CD70 (CD70 Molecule) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    MP0533
    8d
    A Study of ASP2074 in Adults With Solid Tumors (clinicaltrials.gov)
    P1, N=23, Active, not recruiting, Astellas Pharma Global Development, Inc. | Recruiting --> Active, not recruiting | N=193 --> 23
    Enrollment closed • Enrollment change • Metastases
    |
    ASP2074
    8d
    A Phase I Study of BR115 for Injection Alone in Subjects With Advanced Solid Malignancies (clinicaltrials.gov)
    P1, N=120, Not yet recruiting, BioRay Pharmaceutical Co., Ltd.
    New P1 trial • Metastases
    10d
    HPN328, a Trispecific T Cell-activating Protein Construct Targeting DLL3-Expressing Solid Tumors. (PubMed, Mol Cancer Ther)
    Preclinical and nonclinical characterization suggests that HPN328 is a highly efficacious, safe, and novel therapeutic candidate. A phase 1/2 clinical trial is currently underway testing safety and efficacy in patients with DLL3 expressing malignancies.
    Journal • Trispecific
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    MK-6070
    11d
    Glo-BNHL: A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2/3, N=210, Not yet recruiting, University of Birmingham | Trial completion date: Oct 2032 --> May 2033 | Initiation date: Oct 2023 --> May 2024 | Trial primary completion date: Oct 2030 --> May 2031
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    carboplatin • Rituxan (rituximab) • ifosfamide • etoposide IV • dexamethasone • Zynlonta (loncastuximab tesirine-lpyl) • odronextamab (REGN1979)
    11d
    Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Elderly/Unfit Ph- B-ALL (clinicaltrials.gov)
    P2, N=53, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China
    New P2 trial
    |
    Venclexta (venetoclax) • cytarabine • cyclophosphamide • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • vincristine • prednisone • mercaptopurine
    12d
    REALiTEC: A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials (clinicaltrials.gov)
    P=N/A, N=180, Recruiting, Janssen-Cilag Ltd. | Trial completion date: Jul 2024 --> Jan 2026
    Trial completion date
    |
    Tecvayli (teclistamab-cqyv)
    12d
    A Study of BA1202 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=78, Recruiting, Shandong Boan Biotechnology Co., Ltd | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    BA1202
    12d
    MonumenTAL-6: A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide (clinicaltrials.gov)
    P3, N=795, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Jun 2027 --> Apr 2026
    Trial primary completion date • Combination therapy
    |
    lenalidomide • bortezomib • pomalidomide • Empliciti (elotuzumab) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv) • dexamethasone injection
    12d
    Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (clinicaltrials.gov)
    P2, N=171, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Apr 2024 --> Jul 2024
    Trial initiation date • Combination therapy
    |
    MCL1 (Myeloid cell leukemia 1) • KMT2A (Lysine Methyltransferase 2A) • BCL2L1 (BCL2-like 1)
    |
    BCL2 expression
    |
    Venclexta (venetoclax) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • Rylaze (recombinant Erwinia asparaginase) • thioguanine • Hemady (dexamethasone tablets) • Starasid (cytarabine ocfosfate)
    12d
    A Study Comparing the Combination of Dasatinib and Chemotherapy Treatment With or Without Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or Philadelphia Chromosome-Like (Ph-Like) ABL-Class B-Cell Acute Lymphoblastic Leukemia (B-ALL) (clinicaltrials.gov)
    P3, N=680, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Apr 2024 --> Jul 2024
    Trial initiation date
    |
    ABL1 (ABL proto-oncogene 1) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • CD19 (CD19 Molecule) • PDGFRB (Platelet Derived Growth Factor Receptor Beta) • CSF1R (Colony stimulating factor 1 receptor)
    |
    CD19 expression
    |
    TruSight RNA Pan-Cancer Panel
    |
    dasatinib • imatinib • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine • Starasid (cytarabine ocfosfate)
    13d
    Correlation of immune fitness with response to teclistamab in relapsed/refractory multiple myeloma in MajesTEC-1. (PubMed, Blood)
    These findings illustrate the importance of the contribution of the immune landscape to T-cell redirection therapy response. This trial was registered at www.ClinicalTrials.gov, NCT03145181/NCT04557098.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    |
    Tecvayli (teclistamab-cqyv)
    13d
    TALMMY1001-PT3: A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P2, N=450, Recruiting, Janssen Research & Development, LLC | Trial completion date: Apr 2026 --> Dec 2026
    Trial completion date
    |
    Talvey (talquetamab-tgvs)
    14d
    A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Immunoglobulin Light Chain (AL) Amyloidosis Receiving ABBV-383 as an Intravenous (IV) Infusion (clinicaltrials.gov)
    P1/2, N=76, Recruiting, AbbVie | Not yet recruiting --> Recruiting
    Enrollment open • Adverse events
    |
    ABBV-383 IV
    15d
    Study of RO7515629 in Participants With HLA-G Positive Solid Tumors (clinicaltrials.gov)
    P1/2, N=3, Terminated, Hoffmann-La Roche | N=150 --> 3 | Trial completion date: Jan 2027 --> Mar 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2027 --> Mar 2024; Sponsor decision (not related to safety, efficacy or quality).
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    MUC16 (Mucin 16, Cell Surface Associated) • HLA-G (Major Histocompatibility Complex, Class I, G)
    |
    HLA-G positive
    |
    Actemra IV (tocilizumab) • RG6353
    18d
    IMMUNOPLANT for Newly Diagnosed Multiple Myeloma (clinicaltrials.gov)
    P2, N=28, Not yet recruiting, Dickran Kazandjian, MD
    New P2 trial • Combination therapy • Minimal residual disease
    |
    linvoseltamab (REGN5458)
    18d
    GLORIFY: Evaluation of Treatment by Glofitamab in Combination With Rituximab or Obinutuzumab Plus CHOP in Patients With RIchter Syndrome (clinicaltrials.gov)
    P2, N=40, Recruiting, French Innovative Leukemia Organisation | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • Gazyva (obinutuzumab) • cyclophosphamide • vincristine • Columvi (glofitamab-gxbm)
    18d
    Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=130, Not yet recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd.
    New P1 trial • Trispecific
    18d
    A Study of MGD020 Alone or Combined With MGD014 in Persons With HIV-1 on Antiretroviral Therapy (clinicaltrials.gov)
    P1, N=54, Active, not recruiting, MacroGenics | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    CD4 (CD4 Molecule)
    19d
    XmAb541-01: Phase 1, Safety and Tolerability Study of XmAb®541 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=212, Recruiting, Xencor, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    19d
    Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=40, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Gazyva (obinutuzumab) • Calquence (acalabrutinib) • Columvi (glofitamab-gxbm)
    19d
    A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=123, Recruiting, Hefei TG ImmunoPharma Co., Ltd.
    New P1 trial • Metastases
    20d
    Flotetuzumab as a salvage immunotherapy in advanced CD123-positive hematological malignancies, a phase 1 pilot study. (PubMed, Leuk Lymphoma)
    Responses only occurred in Cohort B, with a partial response in one patient with Hodgkin's lymphoma and morphological complete remission in the bone marrow in one patient with blastic plasmacytoid dendritic cell neoplasm. In conclusion, flotetuzumab had a manageable safety profile in advanced CD123-positive hematological malignancies.
    P1 data • Journal • IO biomarker • Metastases
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    CD123 positive • CD123 expression • IL3RA expression • IL3RA positive
    |
    flotetuzumab (MGD006)
    20d
    First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL (clinicaltrials.gov)
    P1, N=47, Active, not recruiting, Sanofi | Trial completion date: Apr 2024 --> Aug 2024
    Trial completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    SAR442257
    20d
    Short-Term Linvoseltamab Treatment, on Top of Chronic Dupilumab Treatment, for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy (clinicaltrials.gov)
    P1, N=6, Not yet recruiting, Regeneron Pharmaceuticals
    New P1 trial
    |
    Dupixent (dupilumab) • linvoseltamab (REGN5458)
    21d
    CO41942: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma (clinicaltrials.gov)
    P1/2, N=187, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Nov 2027 --> Feb 2024
    Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD4 (CD4 Molecule)
    |
    CD20 expression
    |
    lenalidomide • Actemra IV (tocilizumab) • Lunsumio (mosunetuzumab-axgb)
    21d
    A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=316, Recruiting, Hoffmann-La Roche | Phase classification: P1 --> P1/2
    Phase classification
    |
    carfilzomib • Darzalex Faspro (daratumumab/hyaluronidase) • forimtamig (RG6234)
    22d
    Elranatamab in R/R Multiple Myeloma (clinicaltrials.gov)
    P2, N=32, Recruiting, Massachusetts General Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Elrexfio (elranatamab-bcmm) • Abecma (idecabtagene vicleucel)
    25d
    Golden Gate Study: Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P3, N=287, Recruiting, Amgen | Trial completion date: Sep 2031 --> Jan 2032 | Trial primary completion date: Dec 2026 --> Apr 2027
    Trial completion date • Trial primary completion date
    |
    Blincyto (blinatumomab)
    25d
    MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma (clinicaltrials.gov)
    P2, N=120, Recruiting, Pfizer | N=92 --> 120
    Enrollment change • Combination therapy
    |
    lenalidomide • Elrexfio (elranatamab-bcmm) • Ogsiveo (nirogacestat)