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    DRUG CLASS:

    γδ TCR modulator

    Related drugs:
    2d
    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
    2d
    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)
    3d
    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
    24d
    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
    29d
    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
    30d
    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
    1m
    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
    1m
    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
    1m
    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
    1m
    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
    1m
    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
    2ms
    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
    2ms
    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
    2ms
    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
    2ms
    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
    2ms
    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
    3ms
    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
    4ms
    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)
    4ms
    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
    4ms
    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
    5ms
    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
    5ms
    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)
    5ms
    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
    5ms
    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)
    6ms
    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
    6ms
    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
    6ms
    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
    6ms
    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
    6ms
    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
    6ms
    INB-400 Phase 1b/2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells in Combination With Maintenance Temozolomide Recurrent or Newly Diagnosed Glioblastoma (SNO 2023)
    INB-200, a Phase 1 trial, demonstrated the safety and efficacy of autologously (auto) derived genetically modified drug resistant immunotherapy (DRI) gd T cells combined with maintenance temozolomide (TMZ) to treat newly diagnosed (ND) patients with GBM. Allo arm patients must have a haploidentical donor. Fifteen US centers will conduct study.
    Clinical • P1/2 data • Combination therapy
    |
    NKG2D (killer cell lectin like receptor K1)
    |
    IDH wild-type
    |
    temozolomide • INB-200
    7ms
    Inb-100: A Pilot Study of Donor Derived, Ex-Vivo Expanded/Activated Gamma-Delta T Cell (EAGD) Infusion Following Haploidentical Hematopoietic Stem Cell Transplantation and Post-Transplant Cyclophosphamide (PTCy) (ASH 2023)
    Post-BMT infusion of donor-derived, EAGD cells has demonstrated manageable safety with no infusional toxicity or ≥G3 acute GvHD or extensive chronic GvHD. Durable relapse free survival at a maximum of >3 years in subjects with poor risk cytogenetics and adverse clinical risk factors combined with ongoing homeostatic reconstitution of increasing gd T cell effectors post-BMT suggests this therapy may be an effective measure in mitigating relapse after HaploBMT. NCT03533816
    Preclinical • Post-transplantation
    |
    IL6 (Interleukin 6) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • CD27 (CD27 Molecule) • IL15 (Interleukin 15)
    |
    IL6 elevation
    |
    cyclophosphamide • INB-100
    7ms
    Expansion, Persistence and Pharmacodynamic Profile of ADI-001, a First-in-Class Allogeneic CD20-Targeted CAR Gamma Delta T Cell Therapy, in Patients with Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma (ASH 2023)
    ADI-001 Cmax and D28 persistent exposure were comparable to, or exceeded, those demonstrated by alternative allogeneic CAR T therapies and approved autologous CD19 CAR T therapies. Favorable clinical responses were also associated with higher mean and median peak of ADI-001 cells.
    Clinical • PK/PD data
    |
    IL15 (Interleukin 15)
    |
    ADI-001
    7ms
    Impact of Response to Systemic Bridging Therapy on Clinical Outcomes and Cytokine Profiles in Patients Receiving CD19- CAR T-Cell Therapy for B-Cell Lymphoma (ASH 2023)
    BT was classified as Polatuzumab (pola) based, intensive chemotherapy, lenalidomide/ Bruton tyrosine kinases inhibitors (len/BTKi), or others...Among all pts, 86 (47%) received Axicel, 49 (27%) Tisacel, 36 (20%) Lisocel and, 11 (6%) Brexucel... Our findings suggest that achieving a response to BT is associated with reduced tumor burden and inflammatory markers pre-LD, reflecting inherent disease biology and treatment-refractoriness. Further studies are required to evaluate which BT strategies may optimize the inflammatory cytokine environment for improved outcomes after CD19 CAR T cell therapy.
    Clinical • Clinical data • CAR T-Cell Therapy • IO biomarker
    |
    IL6 (Interleukin 6)
    |
    LDH elevation
    |
    lenalidomide • Yescarta (axicabtagene ciloleucel) • Polivy (polatuzumab vedotin-piiq) • Isocel (ALEXIS-ISO-1)
    7ms
    Evaluation of ICT01, a γ9δ2 T Cell-Activating Monoclonal Antibody, Combined with Venetoclax and Azacitidine in 1L AML (EVICTION Study) (ASH 2023)
    ICT01, a first-in-class anti-BTN3A mAb activating γ9δ2 T cells, completed Phase 1 testing in relapsed/refractory (r/r) solid tumors as monotherapy and in combination with pembrolizumab, and as monotherapy in r/r AML and lymphoma (EVICTION-NCT04243499). Encouraging results obtained in the EVICTION Phase 1 trial and preclinical demonstration of the benefit of using ICT01 plus VEN/AZA allowed the initiation of a Phase 2a expansion cohort to evaluate the clinical benefit of this combination in 1L AML patients.
    PD(L)-1 Biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • IL2 (Interleukin 2) • IL10 (Interleukin 10) • IL17A (Interleukin 17A) • IL4 (Interleukin 4)
    |
    Keytruda (pembrolizumab) • Venclexta (venetoclax) • azacitidine • ICT01
    7ms
    A Study of SGN-EGFRd2 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=275, Recruiting, Seagen Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability)
    |
    EGFR mutation • MSI-H/dMMR • ALK rearrangement • EGFR rearrangement
    |
    PF-08046052
    7ms
    UTAA09 Injection in the Treatment of Relapsed/Refractory Hematolymphatic Malignancies. (clinicaltrials.gov)
    P1, N=10, Not yet recruiting, PersonGen BioTherapeutics (Suzhou) Co., Ltd.
    New P1 trial
    |
    IL6 (Interleukin 6)
    |
    CD19 positive
    |
    cyclophosphamide • fludarabine IV
    8ms
    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, Not yet recruiting, Kiromic BioPharma Inc.
    New P1 trial • Combination therapy • Metastases
    |
    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)
    8ms
    QH103 Cell Injection for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P1, N=10, Recruiting, Anhui Provincial Hospital
    New P1 trial
    |
    IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • IL10 (Interleukin 10)
    |
    CD19 positive
    |
    cyclophosphamide • fludarabine IV
    9ms
    Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection (clinicaltrials.gov)
    P1/2, N=25, Recruiting, Dushu Lake Hospital Affiliated to Soochow University
    New P1/2 trial
    |
    IL6 (Interleukin 6) • CD276 (CD276 Molecule) • IL10 (Interleukin 10)
    |
    CD276 expression
    |
    QH104
    9ms
    A Study of SGN-EGFRd2 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=275, Not yet recruiting, Seagen Inc.
    New P1 trial • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability)
    |
    EGFR mutation • MSI-H/dMMR • ALK rearrangement • EGFR rearrangement
    |
    PF-08046052
    11ms
    Trial of LAVA-051 in Patients With Relapsed/Refractory CLL, MM, or AML (clinicaltrials.gov)
    P1/2, N=102, Active, not recruiting, Lava Therapeutics | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    LAVA-051
    11ms
    Induction and Mobilization of Endogenous Bispecific Gamma Delta TCR+ Invariant TCR+ Natural Killer T Cell-Like Cells in Non-Hodgkin's Lymphoma and Solid Tumor Patients (IO-SUMMIT EUROPE 2023)
    Preclinically, activity has been demonstrated against autoreactive T/B cells, immune-resistant lymphoma, xenografted human T-ALL, melanoma, and multiple myeloma. AVM0703 is also effective as neoadjuvant before chemoimmunotherapy or cell transplant.
    Clinical
    |
    dexamethasone sodium phosphate (AVM0703)