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    DRUG CLASS:

    γδ TCR modulator

    Related drugs:
    25d
    Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection (clinicaltrials.gov)
    P1/2, N=25, Suspended, Dushu Lake Hospital Affiliated to Soochow University | Recruiting --> Suspended
    Trial suspension
    |
    CD276 (CD276 Molecule)
    |
    CD276 expression
    |
    QH104
    1m
    A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma (clinicaltrials.gov)
    P1/2, N=4, Active, not recruiting, In8bio Inc. | Recruiting --> Active, not recruiting | N=120 --> 4
    Enrollment closed • Enrollment change
    |
    IDH wild-type
    |
    temozolomide
    1m
    A clinical trial to assess the safety, distribution, effects on certain immune cells and anti-leukaemia effects of LAVA-1266 in patients with acute myeloid leukaemia or certain types of myelodysplastic syndrome (ACTRN12624001214527)
    P1, N=50, Not yet recruiting, LAVA Therapeutics N.V.
    New P1 trial
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    CD123 positive • IL3RA positive
    2ms
    Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT (clinicaltrials.gov)
    P1, N=20, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | N=32 --> 20 | Trial completion date: Jun 2025 --> Sep 2026 | Trial primary completion date: Jun 2025 --> Sep 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    3ms
    A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=30, Recruiting, Cullinan Therapeutics Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CLN-619
    3ms
    SUPLEXA-101: Study of SUPLEXA in Patients With Metastatic Solid Tumours and Haematologic Malignancies (clinicaltrials.gov)
    P1, N=35, Completed, Alloplex Biotherapeutics Inc | Active, not recruiting --> Completed | N=60 --> 35 | Trial completion date: Feb 2025 --> Jul 2024 | Trial primary completion date: Feb 2024 --> Jul 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    4ms
    EVICTION: First-in-Human Study of ICT01 in Patients With Advanced Cancer (clinicaltrials.gov)
    P1/2, N=150, Recruiting, ImCheck Therapeutics | Trial completion date: Jun 2024 --> Dec 2025 | Trial primary completion date: Mar 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
    |
    Keytruda (pembrolizumab) • ICT01
    4ms
    EVICTION-2: Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=100, Recruiting, ImCheck Therapeutics | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Apr 2024 --> Apr 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Proleukin (aldesleukin) • ICT01
    4ms
    On the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of Lymphoma (clinicaltrials.gov)
    P1, N=10, Recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P1 trial
    5ms
    Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT (clinicaltrials.gov)
    P1, N=32, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial primary completion date
    5ms
    GPC3/Mesothelin-CAR-γδT Cells Against Cancers (clinicaltrials.gov)
    P1, N=30, Recruiting, Second Affiliated Hospital of Guangzhou Medical University | Not yet recruiting --> Recruiting | Trial completion date: Dec 2033 --> Dec 2036 | Initiation date: Jan 2024 --> May 2024 | Trial primary completion date: Nov 2026 --> Nov 2030
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
    5ms
    ACHIEVE - Efficacy and Effectiveness of Adoptive Cellular tHerapy wIth Ex-Vivo Expanded Allogeneic γδ T-lymphocytes (TCB008) for Patients With Refractory or Relapsed Acute Myeloid Leukaemia (AML) (clinicaltrials.gov)
    P2, N=53, Recruiting, TC Biopharm | N=148 --> 53 | Trial completion date: May 2024 --> Dec 2025 | Trial primary completion date: May 2023 --> Dec 2025
    Enrollment change • Trial completion date • Trial primary completion date
    |
    cyclophosphamide
    5ms
    ACHIEVE2 - Safety and Preliminary Efficacy of Intravenous TCB008 in Patients With Relapse or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)/AML (clinicaltrials.gov)
    P1, N=69, Not yet recruiting, TC Biopharm
    New P1 trial
    6ms
    Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases (clinicaltrials.gov)
    P1, N=10, Not yet recruiting, PersonGen BioTherapeutics (Suzhou) Co., Ltd.
    New P1 trial
    6ms
    Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer (mCRPC) Resistant Prostate Cancer (clinicaltrials.gov)
    P1/2, N=180, Recruiting, Lava Therapeutics | N=66 --> 180 | Trial completion date: Mar 2024 --> Apr 2027 | Trial primary completion date: Sep 2023 --> Apr 2027
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab)
    6ms
    ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR) (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Acepodia Biotech, Inc.
    New P1 trial • Metastases
    |
    IL2 (Interleukin 2)
    |
    Keytruda (pembrolizumab) • cyclophosphamide • fludarabine IV • ACE2016
    7ms
    A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Cullinan Therapeutics Inc.
    New P1 trial
    |
    CLN-619
    7ms
    A Phase 1 Study of ADI-001 in Lupus Nephritis (clinicaltrials.gov)
    P1, N=40, Not yet recruiting, Adicet Bio, Inc
    New P1 trial
    |
    cyclophosphamide • fludarabine IV • ADI-001
    7ms
    ARYA3: T-Cell Therapy (ECT204) in Adults With Advanced HCC (clinicaltrials.gov)
    P2, N=30, Recruiting, Eureka Therapeutics Inc. | Trial completion date: Dec 2027 --> Dec 2026
    Trial completion date • Metastases
    |
    GPC3 (Glypican 3)
    |
    GPC3 expression • GPC3 positive
    |
    cyclophosphamide • Stivarga (regorafenib) • ECT204
    7ms
    Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases (clinicaltrials.gov)
    P=N/A, N=10, Recruiting, PersonGen BioTherapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    7ms
    Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases (clinicaltrials.gov)
    P=N/A, N=10, Not yet recruiting, PersonGen BioTherapeutics (Suzhou) Co., Ltd.
    New trial
    7ms
    GLEAN-1: A Phase 1 Study of ADI-001 in B Cell Malignancies (clinicaltrials.gov)
    P1, N=78, Recruiting, Adicet Bio, Inc | Trial completion date: Mar 2024 --> Dec 2027 | Trial primary completion date: Mar 2023 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    cyclophosphamide • fludarabine IV • ADI-001
    7ms
    Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1) (clinicaltrials.gov)
    P1/2, N=6, Terminated, Eureka Therapeutics Inc. | N=12 --> 6 | Trial completion date: Jun 2026 --> Jun 2023 | Recruiting --> Terminated | Trial primary completion date: Apr 2024 --> Jun 2023; Directing efforts to the pediatric study (ARYA-2) for this product
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    AFP (Alpha-fetoprotein)
    |
    ET140203
    7ms
    A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=410, Recruiting, Cullinan Oncology Inc. | Trial completion date: Mar 2026 --> Jun 2026 | Trial primary completion date: Sep 2025 --> Mar 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    Keytruda (pembrolizumab) • CLN-619
    8ms
    ARYA3: T-Cell Therapy (ECT204) in Adults With Advanced HCC (clinicaltrials.gov)
    P2, N=24, Recruiting, Eureka Therapeutics Inc. | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2024 --> Dec 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    GPC3 (Glypican 3)
    |
    GPC3 expression • GPC3 positive
    |
    ECT204
    8ms
    Directing the migration of serum-free, ex vivo-expanded Vγ9Vδ2 T cells. (PubMed, Front Immunol)
    To better understand the migration of these cells and possibly influence their migration, NSG mice were conditioned with agents to clear BM cellular compartments, i.e., busulfan or total body irradiation (TBI), or promote T-cell migration to inflamed BM, i.e., incomplete Freund's adjuvant (IFA), prior to administering γδ T cells...Using an established neuroblastoma NSG mouse model, we show that intratumorally-injected γMSCs increase the homing of γδ T cells to this tumor. These studies provide insight into the migration of serum-free, ex vivo-expanded Vγ9Vδ2 T cells in NSG mice, which is critical to understanding the fundamental properties of these cells.
    Preclinical • Journal
    |
    IFNG (Interferon, gamma) • CCL2 (Chemokine (C-C motif) ligand 2) • CCR2 (C-C Motif Chemokine Receptor 2)
    |
    IFNG expression
    |
    busulfan • ET206
    8ms
    Allogenic CD19-targeting CAR-γδT Cell Therapy in r/r NHL (clinicaltrials.gov)
    P1/2, N=30, Recruiting, Chinese PLA General Hospital | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
    |
    CD19 positive • Chr t(11;14) • CCND1 overexpression • BCL6 rearrangement • Chr t(11;14)(q13;q32) • BCL2 rearrangement • CD20 negative
    |
    cyclophosphamide • fludarabine IV
    8ms
    Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC (clinicaltrials.gov)
    P1, N=30, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    PSCA (Prostate Stem Cell Antigen 2)
    |
    cyclophosphamide • fludarabine IV
    8ms
    ARYA3: T-Cell Therapy (ECT204) in Adults With Advanced HCC (clinicaltrials.gov)
    P2, N=24, Recruiting, Eureka Therapeutics Inc. | Phase classification: P1/2 --> P2
    Phase classification • Metastases
    |
    GPC3 (Glypican 3)
    |
    GPC3 expression • GPC3 positive
    |
    ECT204
    9ms
    Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1) (clinicaltrials.gov)
    P1/2, N=12, Recruiting, Eureka Therapeutics Inc. | Phase classification: P2 --> P1/2 | Trial completion date: Jun 2024 --> Jun 2026 | Trial primary completion date: Jan 2024 --> Apr 2024
    Phase classification • Trial completion date • Trial primary completion date • Metastases
    |
    AFP (Alpha-fetoprotein)
    |
    ET140203
    10ms
    Allogeneic Gammadelta T Cells Combined With Interferon-α1b or PD-1 Monoclonal Antibody in Stage III-IV Amenable to Surgical Resection Melanoma (clinicaltrials.gov)
    P1, N=10, Not yet recruiting, Xijing Hospital
    New P1 trial
    |
    Keytruda (pembrolizumab)
    10ms
    A Clinical Study of CD19 Universal CAR-γδT Cells in Refractory/Moderate-to-severe Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1/2, N=15, Recruiting, Wuhan Union Hospital, China | Not yet recruiting --> Recruiting
    Enrollment open
    10ms
    Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, H. Lee Moffitt Cancer Center and Research Institute
    New P1 trial • Metastases
    |
    PSCA (Prostate Stem Cell Antigen 2)
    |
    cyclophosphamide • fludarabine IV
    11ms
    ARYA3: ECT204 T-Cell Therapy in Adults With Advanced HCC (clinicaltrials.gov)
    P1/2, N=24, Recruiting, Eureka Therapeutics Inc. | Trial completion date: Jul 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024 | N=12 --> 24
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    GPC3 (Glypican 3)
    |
    GPC3 expression • GPC3 positive
    |
    ECT204
    11ms
    Aflac-NBL-2002: Allogeneic Expanded Gamma Delta T Cells With GD2 Chemoimmunotherapy in Relapsed or Refractory Neuroblastoma (clinicaltrials.gov)
    P1, N=24, Recruiting, Emory University
    Trial completion date • Trial primary completion date • Combination therapy
    |
    temozolomide • irinotecan • zoledronic acid • Unituxin (dinutuximab)
    11ms
    A Phase 1, Single-arm, Open-label, Dose-escalation Study of JWATM204 as T Cell-targeted Immunotherapy in the Treatment Amongst Subjects With Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P1, N=20, Recruiting, Shanghai Ming Ju Biotechnology Co., Ltd.
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy • Metastases
    |
    cyclophosphamide • ECT204
    11ms
    Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Stage 4 Metastatic NSCLC (clinicaltrials.gov)
    P1, N=48, Recruiting, Kiromic BioPharma Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    12ms
    A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma (clinicaltrials.gov)
    P1/2, N=120, Recruiting, In8bio Inc.
    Trial completion date • Trial primary completion date • Combination therapy
    |
    IDH wild-type
    |
    temozolomide
    12ms
    CAR001: A Safety And Efficacy Study Of Allogeneic CAR Gamma-Delta T Cells in Subjects With Relapsed/Refractory Solid Tumors (clinicaltrials.gov)
    P1/2, N=60, Not yet recruiting, Ever Supreme Bio Technology Co., Ltd.
    New P1/2 trial
    12ms
    GPC3-directed CAR-T in the Treatment Amongst Subjects With Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P1, N=20, Recruiting, Shanghai Ming Ju Biotechnology Co., Ltd.
    New P1 trial • CAR T-Cell Therapy • Metastases
    |
    cyclophosphamide • ECT204
    almost1year
    A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma (clinicaltrials.gov)
    P1/2, N=120, Recruiting, In8bio Inc. | Phase classification: P1b --> P1/2
    Phase classification • Combination therapy
    |
    IDH wild-type
    |
    temozolomide
    1year
    INB-200: Phase 1 Study of Gene Modified Autologous Gamma-delta (γδ) T Cells in Newly Diagnosed Glioblastoma Multiforme (GBM) Patients Receiving Maintenance Temozolomide (TMZ) (SNO 2023)
    γδ T cells successfully infused with peripheral TMZ-based lymphodepletion evidenced with near or below normal range T, B, and NK subsets for up to 1 year. DRI T cells have manageable toxicity with encouraging trend in PFS with enriched γδ T cell remaining despite peripheral lymphodepletion.
    Clinical • P1 data
    |
    MGMT (6-O-methylguanine-DNA methyltransferase) • NKG2D (killer cell lectin like receptor K1)
    |
    IDH wild-type • MGMT expression
    |
    temozolomide • INB-200