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    DRUG:

    TIDAL-01

    i
    Other names: TIDAL-01, TBio-4101
    Associations

    News

    Trials
    Company:
    Xoma
    Drug class:
    Immunostimulant
    Related drugs:
    Associations

    News

    Trials
    6ms
    TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov)
    P1, N=7, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | N=15 --> 7 | Recruiting --> Active, not recruiting
    Enrollment closed • Enrollment change
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • TIDAL-01
    7ms
    Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma (clinicaltrials.gov)
    P1, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | N=25 --> 17
    Enrollment closed • Enrollment change
    |
    BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2)
    |
    BRAF mutation • BRAF V600
    |
    cyclophosphamide • fludarabine IV • TIDAL-01
    10ms
    TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov)
    P1, N=15, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: May 2026 --> Aug 2026 | Trial primary completion date: May 2026 --> Aug 2026
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • TIDAL-01
    10ms
    STARLING: A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=31, Terminated, Turnstone Biologics, Corp. | Recruiting --> Terminated | N=60 --> 31 | Trial completion date: Jun 2025 --> Feb 2025; Sponsor decision
    Enrollment change • Trial completion date • Trial termination
    |
    Keytruda (pembrolizumab) • cyclophosphamide • oxaliplatin • irinotecan • fludarabine IV • TIDAL-01
    11ms
    Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma (clinicaltrials.gov)
    P1, N=25, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial primary completion date
    |
    BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2)
    |
    BRAF mutation • BRAF V600
    |
    cyclophosphamide • fludarabine IV • TIDAL-01
    over1year
    TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov)
    P1, N=15, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • TIDAL-01
    almost2years
    Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma (clinicaltrials.gov)
    P1, N=25, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Jan 2024 --> Aug 2024
    Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2)
    |
    BRAF mutation • BRAF V600
    |
    cyclophosphamide • fludarabine IV • TIDAL-01
    almost2years
    TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, H. Lee Moffitt Cancer Center and Research Institute
    New P1 trial
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • TIDAL-01
    2years
    STARLING: A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=60, Recruiting, Turnstone Biologics, Corp. | Phase classification: P1b --> P1
    Phase classification
    |
    Keytruda (pembrolizumab) • cyclophosphamide • oxaliplatin • irinotecan • TIDAL-01
    over2years
    STARLING: A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1b, N=60, Recruiting, Turnstone Biologics, Corp. | N=30 --> 60
    Enrollment change • Tumor mutational burden • Metastases
    |
    Keytruda (pembrolizumab) • cyclophosphamide • oxaliplatin • irinotecan • TIDAL-01
    over2years
    STARLING: A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1b, N=30, Recruiting, Turnstone Biologics, Corp. | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Tumor mutational burden • Metastases
    |
    Keytruda (pembrolizumab) • cyclophosphamide • oxaliplatin • irinotecan • TIDAL-01
    over2years
    TIDAL-01: A selected TIL process that enriches for neoantigen reactive TIL in solid tumors (AACR 2023)
    TIL from metastatic CRC, melanoma, NSCLC and ovarian tumors were successfully expanded from the majority of patients. Co-culture of TIL and peptide loaded APCs followed by FACS significantly enriched for neoantigen reactivity compared to bulk TIL, demonstrating the potential of the TIDAL-01 process to produce selected TIL products for the treatment of non-melanoma tumors.
    Tumor mutational burden • IO biomarker
    |
    TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • TNFRSF9 (TNF Receptor Superfamily Member 9) • GZMB (Granzyme B) • TNFRSF4 (TNF Receptor Superfamily Member 4)
    |
    TMB-L
    |
    TIDAL-01