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7d
HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA (clinicaltrials.gov)
P1, N=32, Active, not recruiting, Baylor College of Medicine | Trial primary completion date: Oct 2025 --> Jan 2026
Trial primary completion date
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Opdivo (nivolumab) • cyclophosphamide • fludarabine IV
1m
ARTEMIS: Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant (clinicaltrials.gov)
P2, N=92, Terminated, Marker Therapeutics, Inc. | N=47 --> 92 | Completed --> Terminated; Despite a plan to enroll ~195-210 participants, the ARTEMIS study was closed due to the long vein-to-vein manufacturing timeline of MT-401 after 38 participants received the autologous MT-401.
Enrollment change • Trial termination
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zedenoleucel (MT-401)
3ms
Downregulation of MICA/MICB improves cell persistence and clinical activity of NKG2DL CAR T-cells in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic neoplasia. (PubMed, Leukemia)
CYAD-02 presented an higher engraftment and an improved clinical activity (17% objective response rate) compared to CYAD-01 (no objective response). Altogether, our data provide proof of principle that knock-down of MICA/B can enhance CAR T-cell persistence and efficacy while maintaining a good safety profile.
Journal
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MICA (MHC Class I Polypeptide-Related Sequence A) • MICB (MHC Class I Polypeptide-Related Sequence B) • NKG2D (killer cell lectin like receptor K1)
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CYAD-01 • CYAD-02
3ms
A Study of LN-144 in People With Metastatic Melanoma to the Brain (clinicaltrials.gov)
P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2025 --> Nov 2026
Trial completion date • Trial primary completion date
|
Amtagvi (lifileucel)
3ms
Agni-01: Safety and Efficacy of OBX-115 in Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=52, Recruiting, Obsidian Therapeutics, Inc. | Trial completion date: Oct 2027 --> Jun 2028 | Trial primary completion date: Oct 2025 --> Jun 2028
Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • PD-1 (Programmed cell death 1)
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BRAF mutation • BRAF V600
|
cyclophosphamide • fludarabine IV • OBX-115
4ms
Adoptive T-Cell Therapy in Sarcomas. (PubMed, Curr Oncol Rep)
The FDA approval of afamitresgene autoleucel for advanced synovial sarcoma and the breakthrough designation of letetresgene autoleucel for myxoid/round cell liposarcoma signify a major turning point...Tumour infiltrating lymphocyte therapy, including lifileucel, is under investigation with checkpoint inhibitors or oncolytic agents to enhance efficacy and manage toxicity...Challenges include HLA restriction, tumour heterogeneity, and manufacturing complexity. Future strategies involving novel antigens, multi-targeting, and combinatorial regimens could broaden patient eligibility and improve therapeutic outcomes.
Review • Journal
|
HER-2 (Human epidermal growth factor receptor 2) • FGFR4 (Fibroblast growth factor receptor 4) • CD276 (CD276 Molecule) • CTAG1B (Cancer/testis antigen 1B) • MAGEA4 (Melanoma antigen family A, 4)
|
Tecelra (afamitresgene autoleucel) • Amtagvi (lifileucel) • letetresgene autoleucel (GSK3377794)
4ms
Feasibility of Manufacturing and Antitumor Activity of TIL for Advanced Endometrial Cancers. (PubMed, Int J Mol Sci)
These findings demonstrate the feasibility of ex vivo TIL expansion from EC tumors. This study provides a rationale for the initiation of the phase II clinical trial IOV-END-201 (NCT06481592) to evaluate lifileucel in patients with advanced EC.
Journal
|
CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule)
|
Amtagvi (lifileucel)
4ms
HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors (clinicaltrials.gov)
P=N/A, N=19, Terminated, Alaunos Therapeutics | N=2000 --> 19 | Suspended --> Terminated; TCR001-002 protocol was combined with TCR001-201 protocol, which was terminated due to business decisions.
Enrollment change • Trial termination • IO biomarker
5ms
Cost-utility of lifileucel in patients with advanced melanoma after progression on immune checkpoint inhibitors And targeted therapies: a middle-income economy setting. (PubMed, Br J Clin Pharmacol)
The treatment of therapy-resistant advanced melanoma using TILs (lifileucel) is currently not cost-effective in small, middle-income economies and is unlikely to become so in the near future.
Journal • HEOR • Checkpoint inhibition
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BRAF (B-raf proto-oncogene)
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Amtagvi (lifileucel)
6ms
Long-term Efficacy and Safety of Lifileucel Tumor-infiltrating Lymphocyte (TIL) Cell Therapy in Patients with Advanced Melanoma: A 5-year Analysis of the C-144-01 Study. (PubMed, J Clin Oncol)
Most grade 3/4 cytopenias resolved to grade ≤ 2 by day 30. This 5-year analysis demonstrated long-term benefit and meaningful OS with one-time lifileucel therapy, with no additional long-term safety concerns.
Journal • Tumor-infiltrating lymphocyte
|
IL2 (Interleukin 2)
|
Amtagvi (lifileucel)
7ms
RAPA-201 T Cell Therapy for Relapsed, Refractory Multiple Myeloma (clinicaltrials.gov)
P2, N=15, Completed, Rapa Therapeutics LLC | Recruiting --> Completed | N=27 --> 15
Trial completion • Enrollment change
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sirolimus • RAPA-201
7ms
Phase 2b of RAPA-201 Cell Therapy in Post-PD-(L)-1 Melanoma (clinicaltrials.gov)
P2, N=65, Not yet recruiting, Rapa Therapeutics LLC | Initiation date: Mar 2025 --> Nov 2025
Trial initiation date
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carboplatin • paclitaxel • Torisel (temsirolimus) • sirolimus • RAPA-201