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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
TIDAL-01
i
Other names: TIDAL-01, TBio-4101
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News alerts, weekly reports and conference planners
Company:
Turnstone Biologics
Drug class:
Immunostimulant
Related drugs:
2ms
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
3ms
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
3ms
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
6ms
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
11ms
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
12ms
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
1year
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
over1year
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
New P1 trial
|
BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2)
|
BRAF mutation • BRAF V600
|
cyclophosphamide • fludarabine IV • TIDAL-01
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