^
    26d
    TRAIL-R2 and HER2 Bi-Specific Chimeric Antigen Receptor (CAR) T Cells for the Treatment of Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=27, Not yet recruiting, Baylor College of Medicine | Initiation date: Mar 2024 --> Jun 2024
    Trial initiation date • CAR T-Cell Therapy • Metastases
    2ms
    A Clinical Study Evaluating the Safety and Efficacy of Anti-HER2-CAR-T Cells Injection in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=9, Recruiting, China Medical University, China | Not yet recruiting --> Recruiting
    Enrollment open • CAR T-Cell Therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification • HER-2 expression
    |
    cyclophosphamide • fludarabine IV
    2ms
    The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the Recurrent Glioblastoma (clinicaltrials.gov)
    P1, N=16, Recruiting, Shanghai Simnova Biotechnology Co.,Ltd. | Trial primary completion date: Aug 2023 --> May 2024
    Trial primary completion date • CAR T-Cell Therapy
    |
    SNC109
    3ms
    HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases (clinicaltrials.gov)
    P1, N=39, Recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Feb 2025 | Trial primary completion date: Dec 2023 --> Feb 2025
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification
    |
    MB-103
    3ms
    FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=351, Recruiting, Fate Therapeutics
    New P1 trial
    |
    Erbitux (cetuximab) • cisplatin • docetaxel • cyclophosphamide • bendamustine • fludarabine IV
    4ms
    Memory-Enriched T Cells in Treating Patients With Recurrent or Refractory Grade III-IV Glioma (clinicaltrials.gov)
    P1, N=29, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    MB-103
    5ms
    HER2-specific CAR T Cell Locoregional Immunotherapy for HER2-positive Recurrent/Refractory Pediatric CNS Tumors (clinicaltrials.gov)
    P1, N=10, Active, not recruiting, Seattle Children's Hospital | Recruiting --> Active, not recruiting | N=48 --> 10
    Enrollment closed • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    HER2-Specific CAR T
    5ms
    HER2 Targeted HypoSti.CAR-T Cells in HER2 Positive Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=30, Recruiting, Chinese PLA General Hospital | Not yet recruiting --> Recruiting | Initiation date: Jul 2023 --> Oct 2023
    Enrollment open • Trial initiation date • CAR T-Cell Therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    albumin-bound paclitaxel • cyclophosphamide • fludarabine IV • HypoSti.CAR-HER2 T
    7ms
    An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-HER2-CAR-T Cells Injection in Patients With HER2+ Locally Advanced and/ or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=9, Not yet recruiting, China Medical University, China
    New P1 trial • CAR T-Cell Therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification • HER-2 expression
    |
    cyclophosphamide • fludarabine IV
    7ms
    PiggyBac transposon-mediated HER2-CAR-T cells exert anti-tumor efficacy against cholangiocarcinoma (SITC 2023)
    The efficacy of BP2301 in treating CCA was evaluated using Sik01, a CCA patient-derived cell line with moderate HER2 expression that did not respond to Trastuzumab emtansine (T-DM1). Currently, a phase 1 clinical trial is ongoing to evaluate the safety and efficacy of BP2301 in HER2-expressing sarcoma and gynecologic malignancies. Our results about anti-tumor efficacy against CCA provide support for the future development of BP2301 as a potential treatment option for CCA patients with HER2 expression.
    Clinical • CAR T-Cell Therapy • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • CD8 (cluster of differentiation 8) • CD80 (CD80 Molecule)
    |
    HER-2 overexpression • CD8 positive
    |
    Kadcyla (ado-trastuzumab emtansine)
    8ms
    HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases (clinicaltrials.gov)
    P1, N=39, Recruiting, City of Hope Medical Center | Trial completion date: Aug 2023 --> Dec 2023 | Trial primary completion date: Aug 2023 --> Dec 2023
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 expression
    |
    MB-103
    9ms
    iCAR: T Cells Expressing HER2-specific Chimeric Antigen Receptors(CAR) for Patients With HER2-Positive CNS Tumors (clinicaltrials.gov)
    P1, N=10, Active, not recruiting, Baylor College of Medicine | Recruiting --> Active, not recruiting | N=28 --> 10 | Trial completion date: Jan 2036 --> Apr 2037
    Enrollment closed • Enrollment change • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    AU-101
    10ms
    STRIvE-02: B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults (clinicaltrials.gov)
    P1, N=68, Active, not recruiting, Seattle Children's Hospital | Recruiting --> Active, not recruiting
    Enrollment closed • CAR T-Cell Therapy
    |
    CD276 (CD276 Molecule)
    |
    CD276 expression • CD19 expression
    |
    Keytruda (pembrolizumab) • SCRI-CARB7H3(s) • SCRI-CARB7H3(s)x19
    11ms
    HER2 Targeted HypoSti.CAR-T Cells in HER2 Positive Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=30, Not yet recruiting, Chinese PLA General Hospital | Initiation date: Feb 2023 --> Jul 2023
    Trial initiation date • CAR T-Cell Therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    albumin-bound paclitaxel • cyclophosphamide • fludarabine IV • HypoSti.CAR-HER2 T
    1year
    Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors (clinicaltrials.gov)
    P1/2, N=220, Suspended, Bellicum Pharmaceuticals | Recruiting --> Suspended
    Trial suspension • CAR T-Cell Therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification
    |
    Torisel (temsirolimus) • BPX-603
    1year
    Nanoscale, antigen encounter-dependent, IL-12 delivery by CAR T cells plus PD-L1 blockade for cancer treatment. (PubMed, J Transl Med)
    RB-312, the first clinically relevant product incorporating a CRISPRa system with non-gene editing and reversible upregulation of endogenous gene expression that promotes CAR-T cells persistence and effectiveness against HER2-expressing tumors. The autocrine effects of reversible, nanoscale IL-12 production limits the risk of off-tumor leakage and systemic toxicity.
    Journal • CAR T-Cell Therapy • PD(L)-1 Biomarker • IO biomarker
    |
    RELA (RELA Proto-Oncogene)
    |
    HER-2 expression
    |
    RB-312
    over1year
    HER2 Targeted HypoSti.CAR-T Cells in HER2 Positive Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=30, Not yet recruiting, Chinese PLA General Hospital
    New P1/2 trial • CAR T-Cell Therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    albumin-bound paclitaxel • cyclophosphamide • HypoSti.CAR-HER2 T
    over1year
    Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors (clinicaltrials.gov)
    P1/2, N=220, Recruiting, Bellicum Pharmaceuticals | Trial completion date: Jan 2025 --> Jan 2027 | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification
    |
    Torisel (temsirolimus) • BPX-603
    2years
    PLAT-02: A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD19 for Relapsed/Refractory CD19+ Leukemia (clinicaltrials.gov)
    P1/2, N=167, Active, not recruiting, Seattle Children's Hospital | Trial completion date: Sep 2035 --> Jul 2036 | Trial primary completion date: Sep 2020 --> Aug 2021
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule)
    |
    Breyanzi (lisocabtagene maraleucel) • SCRI-huCAR19v1
    over2years
    Contextual reprogramming of CAR-T cells for treatment of HER2 cancers. (PubMed, J Transl Med)
    As the first application of CRISPRi toward a clinically relevant product, RB-340-1 with the conditional, non-gene editing and reversible suppression promotes CAR-T cells resilience to checkpoint inhibition, and their persistence and effectiveness against HER2-expressing cancer xenografts.
    Journal • CAR T-Cell Therapy • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-1 (Programmed cell death 1)
    |
    HER-2 expression
    |
    RB-340
    over2years
    HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases (clinicaltrials.gov)
    P1, N=39, Recruiting, City of Hope Medical Center | Trial completion date: Aug 2021 --> Aug 2023 | Trial primary completion date: Aug 2021 --> Aug 2023
    Clinical • Trial completion date • Trial primary completion date • CAR T-Cell Therapy • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 expression
    |
    MB-103
    over2years
    Memory-Enriched T Cells in Treating Patients With Recurrent or Refractory Grade III-IV Glioma (clinicaltrials.gov)
    P1, N=42, Recruiting, City of Hope Medical Center | Trial completion date: Jun 2021 --> Dec 2023 | Trial primary completion date: Jun 2021 --> Dec 2023
    Clinical • Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    MB-103
    3years
    iCAR: T Cells Expressing HER2-specific Chimeric Antigen Receptors(CAR) for Patients With HER2-Positive CNS Tumors (clinicaltrials.gov)
    P1, N=28, Recruiting, Baylor College of Medicine | Trial completion date: Jan 2031 --> Jan 2036 | Trial primary completion date: Feb 2021 --> Feb 2026
    Clinical • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    AU-101
    3years
    CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma (clinicaltrials.gov)
    P1/2, N=16, Active, not recruiting, Seattle Children's Hospital | Suspended --> Active, not recruiting | N=112 --> 16
    Clinical • Enrollment closed • Enrollment change • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule)
    |
    SCRI-huCAR19v1 • SCRI-huCAR19v2
    over3years
    CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma (clinicaltrials.gov)
    P1/2, N=112, Suspended, Seattle Children's Hospital | Recruiting --> Suspended
    Clinical • Trial suspension • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule)
    |
    SCRI-huCAR19v1 • SCRI-huCAR19v2
    over3years
    VISTA: Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors (clinicaltrials.gov)
    P1, N=45, Recruiting, Baylor College of Medicine | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy • CAR T-Cell Therapy • Oncolytic virus
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    TT16
    over3years
    Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors (clinicaltrials.gov)
    P1/2, N=220, Recruiting, Bellicum Pharmaceuticals
    Clinical • New P1/2 trial • CAR T-Cell Therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification
    |
    Torisel (temsirolimus) • BPX-603
    over3years
    VISTA: Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors (clinicaltrials.gov)
    P1, N=39, Not yet recruiting, Baylor College of Medicine | Trial completion date: Sep 2038 --> Dec 2038 | Trial primary completion date: Sep 2024 --> Dec 2024
    Clinical • Trial completion date • Trial primary completion date • Combination therapy • CAR T-Cell Therapy • Oncolytic virus
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    TT16
    over3years
    CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma (clinicaltrials.gov)
    P1/2, N=112, Recruiting, Seattle Children's Hospital | Active, not recruiting --> Recruiting
    Clinical • Enrollment open • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule)
    |
    SCRI-huCAR19v1 • SCRI-huCAR19v2
    over3years
    Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma (clinicaltrials.gov)
    P1, N=36, Active, not recruiting, Baylor College of Medicine | Trial primary completion date: Jul 2020 --> Dec 2019
    Clinical • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    fludarabine IV • AU-101
    over3years
    HER2/Mesothelin/Lewis-Y/PSCA/MUC1/GPC3/AXL/EGFR/B7-H3/Claudin18.2-CAR-T Cells Immunotherapy Against Cancers (clinicaltrials.gov)
    P1, N=30, Recruiting, Second Affiliated Hospital of Guangzhou Medical University | Trial primary completion date: Aug 2020 --> Aug 2022
    Clinical • Trial primary completion date • CAR T-Cell Therapy • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • AXL (AXL Receptor Tyrosine Kinase) • MUC1 (Mucin 1) • CD276 (CD276 Molecule) • GPC3 (Glypican 3) • PSCA (Prostate Stem Cell Antigen 2)
    |
    MUC1 expression • PSCA Expression
    |
    GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR-CAR-T cells
    almost4years
    VISTA: Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors (clinicaltrials.gov)
    P1, N=39, Not yet recruiting, Baylor College of Medicine | Trial completion date: Jan 2038 --> Sep 2038 | Trial primary completion date: Jan 2024 --> Sep 2024
    Clinical • Trial completion date • Trial primary completion date • Combination therapy • CAR T-Cell Therapy • Oncolytic virus
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    TT16
    4years
    iCAR: T Cells Expressing HER2-specific Chimeric Antigen Receptors(CAR) for Patients With HER2-Positive CNS Tumors (clinicaltrials.gov)
    P1, N=28, Recruiting, Baylor College of Medicine | Trial primary completion date: Feb 2020 --> Feb 2021
    Clinical • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    AU-101
    over4years
    VISTA: Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors (clinicaltrials.gov)
    P1, N=39, Not yet recruiting, Baylor College of Medicine | Trial completion date: Jan 2037 --> Jan 2038 | Trial primary completion date: Jan 2023 --> Jan 2024
    Clinical • Trial completion date • Trial primary completion date • Combination therapy • CAR T-Cell Therapy • Oncolytic virus
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    TT16
    over4years
    Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma (clinicaltrials.gov)
    P1, N=36, Active, not recruiting, Baylor College of Medicine | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    fludarabine IV • AU-101