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    DRUG CLASS:

    CD19 inhibitor

    Related drugs:
    3d
    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)
    3d
    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
    3d
    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
    3d
    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)
    9d
    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 • mercaptopurine
    9d
    Sequencing of anti-CD19 therapies in the management of diffuse large B-cell lymphoma. (PubMed, Clin Cancer Res)
    The anti-CD19 monoclonal antibody tafasitamab, paired with the immunomodulator lenalidomide, mediates antibody-dependent cellular toxicity and cellular phagocytosis; the antibody-drug conjugate loncastuximab tesirine delivers the DNA-cross-linking agent tesirine via CD19 binding and internalization; and CD19-directed chimeric antigen receptor T-cell therapy (CAR-T) products are engineered from autologous T cells. To date, clinical evidence on the effect of anti-CD19 therapy prior to CAR-T is restricted to small case series. Prospective studies and detailed analyses to understand how pre- and post-treatment CD19 expression correlates with clinical responses to subsequent CD19-directed therapy are needed to fully maximize treatment strategies.
    Journal • IO biomarker
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    lenalidomide • Zynlonta (loncastuximab tesirine-lpyl) • Monjuvi (tafasitamab-cxix)
    9d
    N-MOmentum LT: Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) (clinicaltrials.gov)
    P4, N=30, Recruiting, Horizon Therapeutics Ireland DAC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Uplizna (inebilizumab-cdon)
    10d
    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)
    10d
    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; 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)
    12d
    A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN) (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Takeda
    New P1 trial
    |
    cyclophosphamide • TAK-007
    23d
    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)
    24d
    A review of immunotargeted therapy for Philadelphia chromosome positive acute lymphoblastic leukaemia: making progress in chemotherapy-free regimens. (PubMed, Hematology)
    Since 2000, targeted therapy combined with chemotherapy, represented by the tyrosine kinase inhibitor Imatinib, has become the first-line treatment for PH + ALL...More recently, some innovative immune-targeted therapy greatly improved the prognosis of PH + ALL, such as Blinatumomab and Inotuzumab Ozogamicin...These new therapeutic interventions are changing the treatment landscape for PH + ALL. In summary, this review discusses the current advancements in targeted therapeutic agents shift in the treatment strategy of PH + ALL towards using more tolerable chemotherapy-free induction and consolidation regimens confers better disease outcomes and might obviate the need for HSCT.
    Review • Journal • IO biomarker
    |
    ABL1 (ABL proto-oncogene 1)
    |
    imatinib • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    27d
    Study of TG-1801 in Subjects With B-Cell Lymphoma (clinicaltrials.gov)
    P1, N=50, Completed, TG Therapeutics, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    Briumvi (ublituximab-xiiy) • TG-1801
    27d
    Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL (clinicaltrials.gov)
    P1, N=17, Completed, Amgen | Phase classification: P1b --> P1
    Phase classification • Combination therapy
    |
    Blincyto (blinatumomab) • dexamethasone injection • zeluvalimab (AMG 404)
    30d
    Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia (clinicaltrials.gov)
    P3, N=160, Recruiting, Princess Maxima Center for Pediatric Oncology | Not yet recruiting --> Recruiting
    Enrollment open
    |
    KMT2A (Lysine Methyltransferase 2A)
    |
    KMT2A rearrangement • MLL rearrangement
    |
    Blincyto (blinatumomab)
    30d
    Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial primary completion date
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
    |
    BCR-ABL1 fusion
    |
    dasatinib • Blincyto (blinatumomab) • hydroxyurea
    1m
    Blina-CELL: Blinatumomab Followed by High-dose Chemotherapy for Ph-negative Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov)
    P2, N=27, Completed, Institute of Hematology and Blood Transfusion, Czech Republic | Active, not recruiting --> Completed | N=45 --> 27 | Trial completion date: Jul 2024 --> Feb 2024
    Trial completion • Enrollment change • Trial completion date
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    Blincyto (blinatumomab)
    1m
    Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Ph-B-ALL (clinicaltrials.gov)
    P2, N=35, Completed, Chen Suning | Active, not recruiting --> Completed
    Trial completion
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
    |
    cytarabine • Blincyto (blinatumomab)
    1m
    Starlight-1: T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) (clinicaltrials.gov)
    P1/2, N=21, Not yet recruiting, Estrella Biopharma, Inc.
    New P1/2 trial
    1m
    Observational Study of Blinatumomab (clinicaltrials.gov)
    P=N/A, N=279, Completed, Amgen | Active, not recruiting --> Completed
    Trial completion
    |
    Blincyto (blinatumomab)
    1m
    An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE). (clinicaltrials.gov)
    P1, N=60, Not yet recruiting, Novartis Pharmaceuticals
    New P1 trial
    |
    PIT565
    1m
    Study for Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=10, Not yet recruiting, ImmunityBio, Inc.
    New P1 trial • Combination therapy
    |
    Rituxan (rituximab) • CD19.t-haNK
    1m
    A Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=13, Completed, Massachusetts General Hospital | Active, not recruiting --> Completed
    Trial completion
    |
    Blincyto (blinatumomab)
    1m
    Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With r/r Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma (clinicaltrials.gov)
    P1, N=10, Terminated, Amgen | Completed --> Terminated; Amgen decided to discontinue study because of a business decision and not because of safety reasons
    Trial termination
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    AMG 562
    1m
    Palbociclib and chemotherapy followed by blinatumomab consolidation to CAR-T cell therapy in KMT2A-rearranged, therapy-related acute lymphoblastic leukemia. (PubMed, Pediatr Blood Cancer)
    No abstract available
    Journal • CAR T-Cell Therapy
    |
    KMT2A (Lysine Methyltransferase 2A)
    |
    MLL rearrangement
    |
    Ibrance (palbociclib) • Blincyto (blinatumomab)
    1m
    A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients (clinicaltrials.gov)
    P1/2, N=125, Recruiting, Amgen | Trial completion date: Mar 2029 --> Sep 2028 | Trial primary completion date: Jun 2027 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    Blincyto (blinatumomab)
    1m
    NKX019-101: NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With B-cell Cancers (clinicaltrials.gov)
    P1, N=150, Recruiting, Nkarta Inc. | Trial primary completion date: Dec 2023 --> Aug 2024
    Trial primary completion date
    |
    cyclophosphamide • NKX019
    2ms
    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)
    New P2 trial • 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)
    2ms
    Blinatumomab for Treatment of R/R or MRD-positive CD19-Positive MPAL (clinicaltrials.gov)
    P2, N=2, Active, not recruiting, University of Maryland, Baltimore | Trial completion date: Nov 2024 --> Aug 2027
    Trial completion date • Minimal residual disease
    |
    CD81 (CD81 Molecule)
    |
    CD19 positive
    |
    Blincyto (blinatumomab)
    2ms
    Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
    |
    Blincyto (blinatumomab) • Scemblix (asciminib)
    2ms
    Study to Evaluate the Effectiveness of Tafasitamab in Combination With Lenalidomide Followed by Tafasitamab Monotherapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Non-transplant Eligible Patients in Italy (PRO-MIND) (clinicaltrials.gov)
    P=N/A, N=200, Recruiting, Incyte Biosciences Italy S.r.l
    New trial • Combination therapy • Real-world evidence • Real-world
    |
    lenalidomide • Monjuvi (tafasitamab-cxix)
    2ms
    DLI-TARGET: Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab (clinicaltrials.gov)
    P2, N=0, Withdrawn, Ludwig-Maximilians - University of Munich | N=12 --> 0 | Unknown status --> Withdrawn
    Enrollment change • Trial withdrawal • Minimal residual disease
    |
    cytarabine • Blincyto (blinatumomab)
    2ms
    FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101) (clinicaltrials.gov)
    P1, N=322, Recruiting, Fate Therapeutics | Trial completion date: Dec 2039 --> Jun 2044 | Trial primary completion date: Dec 2024 --> Jun 2029
    Trial completion date • Trial primary completion date • Combination therapy
    |
    cyclophosphamide • bendamustine • fludarabine IV • FT522
    2ms
    GNR-084 Safety and Pharmacological Characteristics in Refractory or Relapse B-cell Precursor ALL (clinicaltrials.gov)
    P1/2, N=36, Recruiting, AO GENERIUM | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Dec 2023 --> Feb 2025
    Trial completion date • Trial primary completion date
    |
    CD19 positive
    |
    GNR-084
    2ms
    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; Initiation date: Jan 2024 --> Apr 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)
    2ms
    A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL) (clinicaltrials.gov)
    P2, N=265, Recruiting, Takeda | Trial completion date: Oct 2029 --> Jun 2030 | Trial primary completion date: Oct 2029 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    cyclophosphamide • TAK-007
    2ms
    InMIND: A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. (clinicaltrials.gov)
    P3, N=654, Active, not recruiting, Incyte Corporation | Trial primary completion date: Aug 2024 --> Feb 2024
    Trial primary completion date
    |
    Rituxan (rituximab) • lenalidomide • Monjuvi (tafasitamab-cxix)
    2ms
    NCI-2018-01078: Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=90, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
    |
    cytarabine • Iclusig (ponatinib) • Blincyto (blinatumomab) • methotrexate • Starasid (cytarabine ocfosfate)
    2ms
    Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab (clinicaltrials.gov)
    P1/2, N=40, Not yet recruiting, M.D. Anderson Cancer Center
    New P1/2 trial
    |
    Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • Tecartus (brexucabtagene autoleucel)
    2ms
    J-MIND: To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL) (clinicaltrials.gov)
    P1, N=65, Recruiting, Incyte Biosciences Japan GK | Phase classification: P1b/2 --> P1
    Phase classification
    |
    Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • parsaclisib (INCB50465) • Monjuvi (tafasitamab-cxix)
    2ms
    F01 in the Treatment of Relapsed/Refractory Non-hodgkin's Lymphoma (clinicaltrials.gov)
    P1, N=55, Recruiting, Shanghai Simnova Biotechnology Co.,Ltd. | Initiation date: Jan 2024 --> Apr 2024
    Trial initiation date
    |
    cyclophosphamide • SNC103
    3ms
    Allogeneic CD6 Chimeric Antigen Receptor T Regulatory Cells (CD6-CAR Tregs) for the Treatment of Patients With Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Cell Transplantation (clinicaltrials.gov)
    P1, N=27, Recruiting, City of Hope Medical Center | Initiation date: Jan 2024 --> Jun 2024
    Trial initiation date
    |
    Monjuvi (tafasitamab-cxix)