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    DRUG CLASS:

    TCR modulator

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    Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor (AFNT211-22-101) (NCT06105021)
    Phase 1/2
    Affini-T Therapeutics, Inc.
    Recruiting
    Last update posted :
    02/20/2025
    Initiation :
    03/06/2024
    Primary completion :
    12/01/2025
    Completion :
    12/01/2029
    KRAS
    |
    KRAS mutation • KRAS G12
    |
    AFNT-211
    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 (NT-175-201) (NCT05877599)
    Phase 1
    AstraZeneca
    Recruiting
    Last update posted :
    02/20/2025
    Initiation :
    07/12/2023
    Primary completion :
    09/01/2028
    Completion :
    08/01/2039
    TP53 • HLA-A
    |
    TP53 mutation • HLA-A*02:01
    |
    cyclophosphamide • fludarabine IV • NT-175
    A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma (TCR-T) (NCT05417932)
    Phase 1/2
    SCG Cell Therapy Pte. Ltd.
    Recruiting
    Last update posted :
    02/18/2025
    Initiation :
    10/26/2022
    Primary completion :
    09/01/2025
    Completion :
    10/01/2025
    STMN2
    |
    SCG101
    IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor (IMA401-101) (NCT05359445)
    Phase 1
    Immatics Biotechnologies GmbH
    Recruiting
    Last update posted :
    01/28/2025
    Initiation :
    05/19/2022
    Primary completion :
    11/01/2025
    Completion :
    12/01/2029
    MAGEA4
    |
    MAGEA4 expression • MAGEA4 overexpression
    |
    Keytruda (pembrolizumab) • IMA401
    A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related (NCT06617000)
    Phase 1
    SCG Cell Therapy Pte. Ltd.
    Recruiting
    Last update posted :
    09/27/2024
    Initiation :
    10/25/2022
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    STMN2
    |
    SCG101
    A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors (NCT05973487)
    Phase 1
    TScan Therapeutics, Inc.
    Recruiting
    Last update posted :
    06/14/2024
    Initiation :
    05/06/2024
    Primary completion :
    12/30/2026
    Completion :
    12/30/2026
    HLA-A • PRAME • HLA-C
    |
    HLA-A*02
    |
    T-Plex-200-A0201/204-A0201 • TSC-200-A0201 • TSC-204-A0201 • TSC-204-C0702
    A Study of NT-112 in HLA-C*08:02-Positive Adult Subjects With Unresectable, Advanced, and/ or Metastatic Solid Tumors Positive for the KRAS G12D Mutation (NCT06218914)
    Phase 1
    Neogene Therapeutics, Inc.
    Recruiting
    Last update posted :
    06/14/2024
    Initiation :
    02/05/2024
    Primary completion :
    08/30/2025
    Completion :
    01/02/2040
    KRAS
    |
    cyclophosphamide
    A Study of TSC-100 and TSC-101 in AML, ALL and MDS Patients Undergoing Haploidentical Donor Transplantation (TSCAN-001) (NCT05473910)
    Phase 1
    TScan Therapeutics, Inc.
    Recruiting
    Last update posted :
    06/13/2024
    Initiation :
    11/01/2022
    Primary completion :
    12/01/2024
    Completion :
    06/01/2025
    HLA-A
    |
    HLA-A*02 • HLA-A2 positive • HLA-A positive
    |
    melphalan • TSC-100 • TSC-101
    Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors (NCT05450562)
    Phase 1/2
    Sanofi
    Recruiting
    Last update posted :
    05/30/2024
    Initiation :
    09/20/2022
    Primary completion :
    12/12/2030
    Completion :
    12/12/2030
    ALK • GPC3
    |
    GPC3 expression • GPC3 positive
    |
    Tecentriq (atezolizumab) • Libtayo (cemiplimab-rwlc) • SAR444200
    A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer (NCT05989828)
    Phase 1
    University of Southern California
    Not yet recruiting
    Last update posted :
    05/24/2024
    Initiation :
    08/01/2024
    Primary completion :
    08/01/2026
    Completion :
    08/01/2027
    HER-2 • PD-L1 • ER • PGR • CTAG1B
    |
    HER-2 negative • PGR negative
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • NY-ESO-1 TCR
    Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO) (NCT03967223)
    Phase 2
    Adaptimmune
    Active, not recruiting
    Last update posted :
    04/25/2024
    Initiation :
    12/31/2019
    Primary completion :
    08/28/2024
    Completion :
    07/31/2026
    HLA-A • CTAG1B
    |
    HLA-A*02:01 • HLA-A*02 • CTAG1B expression • HLA-A2 positive
    |
    cyclophosphamide • fludarabine IV • letetresgene autoleucel (GSK3377794) • cyclophosphamide intravenous
    SPEARHEAD-3 Pediatric Study (NCT05642455)
    Phase 1/2
    Adaptimmune
    Recruiting
    Last update posted :
    04/24/2024
    Initiation :
    09/01/2023
    Primary completion :
    10/01/2026
    Completion :
    07/30/2038
    HLA-A • MAGEA4
    |
    HLA-A*02 • HLA-A2 positive • MAGEA4 expression
    |
    Tecelra (afamitresgene autoleucel)
    NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors (NCT05881525)
    Phase 1
    TCRCure Biopharma Ltd.
    Recruiting
    Last update posted :
    04/12/2024
    Initiation :
    06/01/2023
    Primary completion :
    10/01/2024
    Completion :
    03/01/2025
    CTAG1B
    |
    CTAG1B expression
    |
    albumin-bound paclitaxel • cyclophosphamide • fludarabine IV • N201
    Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer (ATTAC-MCC) (NCT03747484)
    Phase 1/2
    Fred Hutchinson Cancer Center
    Active, not recruiting
    Last update posted :
    03/26/2024
    Initiation :
    07/03/2019
    Primary completion :
    01/10/2024
    Completion :
    01/10/2025
    HLA-A
    |
    HLA-A*02
    |
    Keytruda (pembrolizumab) • Bavencio (avelumab) • Actimmune (interferon gamma-1 b) • MCC1 TCR
    Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (SPEARHEAD-1) (NCT04044768)
    Phase 2
    Adaptimmune
    Recruiting
    Last update posted :
    02/19/2024
    Initiation :
    08/13/2019
    Primary completion :
    10/10/2021
    Completion :
    04/01/2038
    HLA-A • MAGEA4
    |
    HLA-A*02 • MAGEA4 expression
    |
    Tecelra (afamitresgene autoleucel)
    HRYZ-T101 TCR-T Cell for HPV-18 Positive Advanced Solid Tumor (NCT05787535)
    Phase 1
    HRYZ Biotech Co.
    Recruiting
    Last update posted :
    02/02/2024
    Initiation :
    03/21/2023
    Primary completion :
    02/01/2025
    Completion :
    09/01/2025
    HLA-DRB1
    |
    cyclophosphamide • fludarabine IV • HRYZ-T101
    HRYZ-T101 Injection for HPV18 Positive Solid Tumor (NCT05952947)
    Phase 1
    HRYZ Biotech Co.
    Recruiting
    Last update posted :
    02/02/2024
    Initiation :
    11/01/2023
    Primary completion :
    12/01/2027
    Completion :
    02/01/2028
    HLA-DRB1
    |
    cyclophosphamide • fludarabine IV • HRYZ-T101
    MAGE-A4ᶜ¹º³²T for Multi-Tumor (NCT03132922)
    Phase 1
    Adaptimmune
    Active, not recruiting
    Last update posted :
    01/22/2024
    Initiation :
    05/15/2017
    Primary completion :
    12/27/2022
    Completion :
    09/01/2032
    HLA-A • MAGEA4
    |
    HLA-A*02 • HLA-A2 positive
    |
    Tecelra (afamitresgene autoleucel)
    Mesothelin-Specific T-Cells (FH-TCR-Tᴍsʟɴ) for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (NCT04809766)
    Phase 1
    Fred Hutchinson Cancer Center
    Recruiting
    Last update posted :
    01/09/2024
    Initiation :
    12/14/2021
    Primary completion :
    06/30/2024
    Completion :
    06/30/2025
    HLA-A • MSLN
    |
    MSLN expression • HLA-A*02
    |
    cyclophosphamide • bendamustine • fludarabine IV • FH-TCR-Tᴍsʟɴ • cyclophosphamide intravenous
    Phase II Study of TAEST16001 in Soft Tissue Sarcoma (NCT05549921)
    Phase 2
    Sun Yat-sen University
    Recruiting
    Last update posted :
    12/27/2023
    Initiation :
    07/08/2022
    Primary completion :
    09/01/2024
    Completion :
    09/01/2024
    HLA-A • CTAG1B
    |
    HLA-A*02:01 • HLA-A*02
    |
    TAEST16001
    Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors (NCT02869217)
    Phase 1
    University Health Network, Toronto
    Active, not recruiting
    Last update posted :
    12/08/2023
    Initiation :
    09/01/2016
    Primary completion :
    09/01/2024
    Completion :
    09/01/2024
    HLA-A • CTAG1B
    |
    HLA-A*02 • CTAG1B expression
    |
    cyclophosphamide • fludarabine IV • mipetresgene autoleucel (TBI-1301) • cyclophosphamide intravenous
    Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T Lymphocytes) in Patients With Synovial Sarcoma (NCT03250325)
    Phase 1/2
    Takara Bio Inc.
    Completed
    Last update posted :
    12/06/2023
    Initiation :
    09/20/2017
    Primary completion :
    01/23/2020
    Completion :
    03/09/2022
    HLA-A • CTAG1B
    |
    HLA-A*02 • CTAG1B expression
    |
    cyclophosphamide • mipetresgene autoleucel (TBI-1301) • cyclophosphamide intravenous
    Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV) (NCT04745403)
    Phase 1
    Lion TCR Pte. Ltd.
    Recruiting
    Last update posted :
    11/17/2023
    Initiation :
    05/20/2022
    Primary completion :
    07/01/2026
    Completion :
    07/01/2028
    HLA-A
    |
    HLA-A*02 • HLA-A*24:02 • HLA-A*24
    |
    LioCyx-M
    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 (NCT05993299)
    Phase 2
    GlaxoSmithKline
    Active, not recruiting
    Last update posted :
    10/16/2023
    Initiation :
    12/31/2019
    Primary completion :
    10/12/2022
    Completion :
    07/01/2024
    HLA-A • CTAG1B
    |
    HLA-A*02:01 • HLA-A*02 • CTAG1B expression • HLA-A2 positive
    |
    cyclophosphamide • fludarabine IV • letetresgene autoleucel (GSK3377794)
    Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Solid Tumor (NCT05933668)
    Phase 1
    Peking University
    Not yet recruiting
    Last update posted :
    07/06/2023
    Initiation :
    07/01/2023
    Primary completion :
    07/01/2024
    Completion :
    07/01/2026
    KRAS
    |
    KRAS G12V • KRAS G12
    |
    cyclophosphamide • oxaliplatin • YK0901
    TAEST16001 in the Treatment of Soft Tissue Sarcoma (NCT04318964)
    Phase 1
    Sun Yat-sen University
    Active, not recruiting
    Last update posted :
    04/12/2023
    Initiation :
    03/19/2020
    Primary completion :
    04/15/2022
    Completion :
    05/01/2024
    IL6 • CTAG1B
    |
    TAEST16001
    NY-ESO-1-specific T Cell Receptor (TCR) T Cell in Sarcoma (NCT03462316)
    Phase 1
    Sun Yat-sen University
    Active, not recruiting
    Last update posted :
    04/12/2023
    Initiation :
    05/21/2018
    Primary completion :
    02/15/2024
    Completion :
    05/15/2024
    CTAG1B
    |
    cyclophosphamide • TAEST16001
    Letetresgene Autoleucel Engineered T Cells in NY-ESO-1 Positive Participants With Advanced Myxoid/ Round Cell Liposarcoma (ADP-0011-007) (NCT02992743)
    Phase 2
    GlaxoSmithKline
    Completed
    Last update posted :
    04/11/2023
    Initiation :
    12/06/2016
    Primary completion :
    11/01/2021
    Completion :
    03/22/2022
    HLA-A • CTAG1B
    |
    HLA-A*02 • CTAG1B expression
    |
    cyclophosphamide • fludarabine IV • letetresgene autoleucel (GSK3377794) • cyclophosphamide intravenous
    AFPᶜ³³²T in Advanced HCC (NCT03132792)
    Phase 1
    Adaptimmune
    Active, not recruiting
    Last update posted :
    08/29/2022
    Initiation :
    05/08/2017
    Primary completion :
    07/07/2021
    Completion :
    07/07/2036
    AFP
    |
    AFP expression
    |
    ADP-A2AFP
    A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors (NCT03970382)
    Phase 1a/1b
    PACT Pharma, Inc.
    Suspended
    Last update posted :
    08/18/2022
    Initiation :
    07/03/2019
    Primary completion :
    08/12/2022
    Completion :
    08/12/2022
    IL2
    |
    Opdivo (nivolumab) • Proleukin (aldesleukin) • NeoTCR-P1
    Autologous HBV-specific T Cell Receptor Engineered T Cells (TCR-T) in Patients With HBV-related Advanced HCC (NCT05339321)
    Phase 1
    Peking Union Medical College Hospital
    Recruiting
    Last update posted :
    05/10/2022
    Initiation :
    04/14/2021
    Primary completion :
    07/01/2023
    Completion :
    12/01/2023
    STMN2
    |
    SCG101
    T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-DP0401 Positive (NCT02111850)
    Phase 1/2
    National Cancer Institute (NCI)
    Completed
    Last update posted :
    03/29/2022
    Initiation :
    02/07/2014
    Primary completion :
    03/24/2021
    Completion :
    03/24/2021
    CD4 • GAPDH • MAGEA3
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • MAGE A3 TCR • cyclophosphamide intravenous
    SPEARHEAD 2 Study in Subjects With Recurrent or Metastatic Head and Neck Cancer ( SPEARHEAD-2) (NCT04408898)
    Phase 2
    Adaptimmune
    Withdrawn
    Last update posted :
    11/16/2021
    Initiation :
    07/02/2020
    Primary completion :
    12/01/2021
    Completion :
    12/01/2021
    HLA-A • MAGEA4
    |
    HLA-A*02 • HLA-A2 positive • MAGEA4 expression
    |
    Keytruda (pembrolizumab) • Tecelra (afamitresgene autoleucel)
    Letetresgene Autoleucel Engineered T Cells in NY-ESO -1 Positive Advanced Non-Small Cell Lung Cancer (NSCLC) (NCT02588612)
    Phase 1
    GlaxoSmithKline
    Completed
    Last update posted :
    09/05/2021
    Initiation :
    02/01/2016
    Primary completion :
    08/10/2020
    Completion :
    08/10/2020
    EGFR • ALK • ROS1 • HLA-A • CTAG2
    |
    EGFR mutation • ALK rearrangement • HLA-A*02 • CTAG2 expression
    |
    cyclophosphamide • fludarabine IV • letetresgene autoleucel (GSK3377794) • cyclophosphamide intravenous
    A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma (ADP 04511) (NCT01343043)
    Phase 1
    GlaxoSmithKline
    Completed
    Last update posted :
    06/30/2021
    Initiation :
    09/27/2012
    Primary completion :
    06/18/2019
    Completion :
    06/18/2019
    HLA-A • CTAG1B
    |
    HLA-A*02 • CTAG1B expression
    |
    cyclophosphamide • fludarabine IV • letetresgene autoleucel (GSK3377794)
    Investigator Initiated Phase 1 Study of TBI-1201 (NCT02096614)
    Phase 1
    Mie University
    Completed
    Last update posted :
    06/18/2021
    Initiation :
    04/01/2014
    Primary completion :
    03/01/2021
    Completion :
    03/01/2021
    MAGEA4
    |
    MAGEA4 expression • HLA-A*24
    |
    cyclophosphamide • fludarabine IV • TBI 1201 • cyclophosphamide intravenous