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    DRUG CLASS:

    TCR modulator

    Related drugs:
    27d
    Phase 1/2a Ascending Dose Study to Evaluate the Safety BSB-1001 in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS (clinicaltrials.gov)
    P1/2, N=38, Not yet recruiting, BlueSphere Bio, Inc
    New P1/2 trial
    |
    melphalan • BSB-1001
    27d
    Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants with NY-ESO-1 Positive Previously Treated Advanced (Metastatic or Unresectable) Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (clinicaltrials.gov)
    P2, N=87, Active, not recruiting, Adaptimmune
    New P2 trial • Metastases
    |
    cyclophosphamide • letetresgene autoleucel (GSK3377794)
    30d
    Safety and Tolerability of Letetresgene Autoleucel (Lete-cel; GSK3377794): Pilot Studies in Patients With Advanced Non-Small Cell Lung Cancer. (PubMed, Clin Cancer Res)
    Extensive HLA-A*02 and antigen expression testing was performed to identify potential participants. Lete-cel was generally well tolerated and had no unexpected AEs. Anti-tumor activity was observed in a limited number of patients.
    Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • CTAG2 (Cancer/testis antigen 2)
    |
    HLA-A*02:01 • HLA-A*02 • HLA-A2 positive • HLA-A positive
    |
    Keytruda (pembrolizumab) • letetresgene autoleucel (GSK3377794)
    2ms
    Legumain deficiency halts atherogenesis by modulating T cell receptor signaling. (PubMed, Aging Cell)
    These results suggest that legumain deficiency may play a role in the development of atherosclerosis by impairing the survival, proliferation, and function of CD4+ T cells. Inhibition of legumain activity may be an innovative therapy for the treatment of atherosclerosis.
    Journal
    |
    BCL2 (B-cell CLL/lymphoma 2) • CD4 (CD4 Molecule) • APOE (Apolipoprotein E)
    2ms
    ATTAC-MCC: Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer (clinicaltrials.gov)
    P1/2, N=7, Terminated, Fred Hutchinson Cancer Center | Trial completion date: Jan 2025 --> Jan 2024 | Active, not recruiting --> Terminated; Terminated due to insufficient funding
    Trial completion date • Trial termination • Metastases • Immune cell
    |
    HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    HLA-A*02
    |
    Keytruda (pembrolizumab) • Bavencio (avelumab) • Actimmune (interferon gamma-1 b) • MCC1 TCR
    2ms
    Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel) (clinicaltrials.gov)
    P1, N=39, Not yet recruiting, M.D. Anderson Cancer Center
    New P1 trial
    |
    cyclophosphamide • fludarabine IV
    2ms
    Mesothelin-Specific T-Cells (FH-TCR-Tᴍsʟɴ) for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1, N=9, Active, not recruiting, Fred Hutchinson Cancer Center | Recruiting --> Active, not recruiting | N=15 --> 9
    Enrollment closed • Enrollment change
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MSLN (Mesothelin)
    |
    MSLN expression • HLA-A*02
    |
    cyclophosphamide • bendamustine • fludarabine IV • FH-TCR-Tᴍsʟɴ
    2ms
    Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma (clinicaltrials.gov)
    P2, N=7, Active, not recruiting, Adaptimmune | Trial completion date: Jul 2024 --> Jul 2025
    Trial completion date • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
    |
    HLA-A*02:01 • HLA-A*02 • CTAG1B expression • HLA-A2 positive
    |
    cyclophosphamide • fludarabine IV • letetresgene autoleucel (GSK3377794)
    2ms
    IMC-C103C-101: Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, Immunocore Ltd | N=75 --> 0 | Terminated --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MAGEA4 (Melanoma antigen family A, 4)
    |
    HLA-A*02
    |
    Tecentriq (atezolizumab) • IMC-C103C
    2ms
    Afamitresgene Autoleucel: First Approval. (PubMed, Mol Diagn Ther)
    In August 2024, afamitresgene autoleucel was approved in the USA under accelerated approval for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P or -A*02:06P positive and whose tumour expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. This article summarizes the milestones in the development of afamitresgene autoleucel leading to this first approval for the treatment of advanced synovial sarcoma.
    Review • Journal • IO Companion diagnostic
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MAGEA4 (Melanoma antigen family A, 4)
    |
    HLA-A*02
    |
    Tecelra (afamitresgene autoleucel)
    2ms
    Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, University Health Network, Toronto | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
    |
    HLA-A*02 • CTAG1B expression
    |
    cyclophosphamide • fludarabine IV • mipetresgene autoleucel (TBI-1301)
    3ms
    A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related (clinicaltrials.gov)
    P1, N=38, Recruiting, SCG Cell Therapy Pte. Ltd.
    New P1 trial
    |
    STMN2 (Stathmin 2)
    |
    SCG101
    3ms
    Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel (clinicaltrials.gov)
    P=N/A, N=0, Available, Adaptimmune
    New trial
    |
    Tecelra (afamitresgene autoleucel)
    3ms
    ABA-101 in Participants with Progressive Multiple Sclerosis (clinicaltrials.gov)
    P1, N=12, Recruiting, Abata Therapeutics | Not yet recruiting --> Recruiting
    Enrollment open
    3ms
    TITANium: A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies. (clinicaltrials.gov)
    P1/2, N=174, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    3ms
    Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies (clinicaltrials.gov)
    P1/2, N=54, Recruiting, M.D. Anderson Cancer Center | Active, not recruiting --> Recruiting
    Enrollment open
    |
    cyclophosphamide • decitabine • fludarabine IV
    3ms
    Individualized Tumor Specific TCR- T Cells in the Treatment of Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=30, Recruiting, Guangzhou FineImmune Biotechnology Co., LTD. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jul 2024 --> Oct 2025
    Trial completion date • Trial primary completion date • Metastases
    4ms
    Brief Communication on MAGE-A4 and Coexpression of Cancer Testis Antigens in Metastatic Synovial Sarcomas: Considerations for Development of Immunotherapeutics. (PubMed, J Immunother)
    Among MAGE-As, MAGE-A4 had the highest prevalence (65%), followed by MAGE-A10 (15%) and MAGE-A9 (13%)...Complementary immunohistochemical analyses were used to establish the positive correlation between RNA and protein expression for MAGE-A4 and NY-ESO-1. These data inform the strategy for optimal coverage of the SyS patient population with T-cell therapies, offering patients with SyS new options for single or combined second lines of treatment.
    Journal • IO biomarker • Metastases
    |
    CTAG1B (Cancer/testis antigen 1B) • MAGEA4 (Melanoma antigen family A, 4) • PRAME (Preferentially Expressed Antigen In Melanoma)
    |
    MAGEA4 expression
    |
    ADP-A2M10
    4ms
    ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors (clinicaltrials.gov)
    P1, N=476, Recruiting, Immatics US, Inc. | N=186 --> 476
    Enrollment change
    |
    Opdivo (nivolumab) • IMA203 • IMA203CD8
    4ms
    An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease (clinicaltrials.gov)
    P=N/A, N=6, Recruiting, China Immunotech (Beijing) Biotechnology Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    4ms
    A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation (clinicaltrials.gov)
    P1, N=162, Recruiting, Neogene Therapeutics, Inc. | N=24 --> 162
    Enrollment change • Metastases
    |
    TP53 (Tumor protein P53) • HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    cyclophosphamide • NT-175
    4ms
    ABA-101 in Participants With Progressive Multiple Sclerosis (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, Abata Therapeutics
    New P1 trial
    4ms
    MB-dNPM1-TCR.1 in Relapsed/Refractory AML (clinicaltrials.gov)
    P1/2, N=29, Recruiting, Miltenyi Biomedicine GmbH | Not yet recruiting --> Recruiting
    Enrollment open
    4ms
    AFPᶜ³³²T in Advanced HCC (clinicaltrials.gov)
    P1, N=45, Active, not recruiting, Adaptimmune | Trial completion date: Jul 2036 --> Jul 2025
    Trial completion date • Metastases
    |
    AFP (Alpha-fetoprotein)
    |
    ADP-A2AFP
    5ms
    Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies (clinicaltrials.gov)
    P1/2, N=54, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cyclophosphamide • decitabine • fludarabine IV
    5ms
    SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas (clinicaltrials.gov)
    P1, N=18, Recruiting, The Affiliated Hospital of Qingdao University
    New P1 trial • Metastases
    5ms
    TITANium: A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies. (clinicaltrials.gov)
    P1/2, N=174, Not yet recruiting, AstraZeneca
    New P1/2 trial
    5ms
    FDA Grants Thermo Fisher Scientific SeCore HLA Typing Kit 510(k) Clearance for Use as Companion Diagnostic with a T-Cell Receptor Therapy for Synovial Sarcoma (Businesswire)
    "Thermo Fisher Scientific Inc...announced that its SeCore CDx HLA A Sequencing System has been granted 510(k) clearance by the United States Food and Drug Administration (FDA) for use as a companion diagnostic with TECELRA (afamitresgene autoleucel), Adaptimmune’s newly approved T-cell receptor (TCR) therapy for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. Synovial sarcoma is a rare, soft tissue cancer that most commonly impacts young adults."
    FDA event
    |
    SeCore CDx HLA Sequencing System
    |
    Tecelra (afamitresgene autoleucel)
    5ms
    Starlight-1: T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) (clinicaltrials.gov)
    P1/2, N=21, Recruiting, Estrella Biopharma, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    5ms
    Agilent Receives FDA Approval for MAGE-A4 IHC 1F9 pharmDx as a Diagnostic Tool for Use with Newly Approved TCR T-Cell Therapy (Businesswire)
    "Agilent Technologies Inc...announced that it has received FDA approval for the use of MAGE-A4 IHC 1F9 pharmDx (SK032) as a diagnostic tool to aid in identifying patients with synovial sarcoma who may be eligible for treatment with TECELRA (afamitresgene autoleucel, also known as afami-cel or ADP-A2M4), a MAGE-A4-directed engineered TCR T-Cell therapy."
    FDA event
    |
    MAGE-A4 IHC 1F9 pharmDx (SK032)
    |
    Tecelra (afamitresgene autoleucel)
    5ms
    HRYZ-T102 TCR-T Cell for AFP Positive Advanced HCC and Other Solid Tumors (clinicaltrials.gov)
    P1, N=12, Recruiting, HRYZ Biotech Co.
    New P1 trial • Metastases
    |
    cyclophosphamide
    5ms
    Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma (clinicaltrials.gov)
    P1/2, N=66, Not yet recruiting, SCG Cell Therapy Pte. Ltd.
    New P1/2 trial
    |
    cyclophosphamide • fludarabine IV
    5ms
    KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer (clinicaltrials.gov)
    P1, N=30, Recruiting, Christian Hinrichs | Trial primary completion date: Sep 2025 --> Sep 2026
    Trial primary completion date • Gene therapy
    |
    cyclophosphamide • Proleukin (aldesleukin)
    6ms
    IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations (clinicaltrials.gov)
    P1, N=12, Recruiting, Shanghai Pudong Hospital
    New P1 trial • Metastases
    6ms
    NW-301 TCR-T in Patients With Advanced Solid Tumor (clinicaltrials.gov)
    P1, N=9, Recruiting, Tao Zhang
    New P1 trial • Metastases
    6ms
    NW-301 TCR-T in Patients With Advanced Solid Tumor (clinicaltrials.gov)
    P1, N=9, Recruiting, Ting Deng
    New P1 trial • Metastases
    6ms
    Mesothelin-Specific T-Cells (FH-TCR-Tᴍsʟɴ) for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1, N=15, Recruiting, Fred Hutchinson Cancer Center | Trial primary completion date: Jun 2024 --> Dec 2024
    Trial primary completion date • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MSLN (Mesothelin)
    |
    cyclophosphamide • bendamustine • fludarabine IV • FH-TCR-Tᴍsʟɴ
    6ms
    T Cell Receptor (TCR) Sequencing and Transcriptional Profiling in Adult Celiac Disease Patients Undergoing Gluten Challenge (clinicaltrials.gov)
    P=N/A, N=24, Completed, Regeneron Pharmaceuticals | Recruiting --> Completed | Trial completion date: Sep 2024 --> May 2024 | Trial primary completion date: Sep 2024 --> May 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    T-cell receptor therapy
    6ms
    Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies (clinicaltrials.gov)
    P1/2, N=54, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting | Initiation date: Oct 2024 --> Jun 2024
    Enrollment open • Trial initiation date
    |
    cyclophosphamide • decitabine • fludarabine IV
    7ms
    Genetically redirected HBV-specific T cells target HBsAg-positive hepatocytes and primary lesions in HBV-associated HCC. (PubMed, Clin Mol Hepatol)
    Transferred T cells expanded, developed a stem cell-like memory phenotype, and were still detectable after six months in the patient's blood. SCG101 T-cell therapy showed encouraging efficacy and safety in pre-clinical models and in a patient with primary HBV-HCC and concomitant chronic hepatitis B with the capability to eliminate HBsAg+ cells and achieve sustained tumor control after single dosing.
    Journal
    |
    STMN2 (Stathmin 2)
    |
    SCG101
    7ms
    A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, University of Southern California | Trial completion date: Apr 2027 --> Aug 2027 | Initiation date: Apr 2024 --> Aug 2024 | Trial primary completion date: Apr 2026 --> Aug 2026
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CTAG1B (Cancer/testis antigen 1B)
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • NY-ESO-1 TCR
    8ms
    Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies (clinicaltrials.gov)
    P1/2, N=54, Not yet recruiting, M.D. Anderson Cancer Center
    New P1/2 trial
    |
    cyclophosphamide • decitabine • fludarabine IV