USO 23055
ICT01-101: Isang first-in-human, two-part, open-label, clinical study para masuri ang kaligtasan, tolerability at aktibidad ng intravenous doses ng ICT01 bilang monotherapy at kasama ng immune checkpoint inhibitor, sa mga pasyenteng may advanced- stage, relapsed/refractory cancer (EVICTION Study) (ICT01-101)
Mga Uri ng Sakit: Cellular at Gene
Mga Kinakailangan sa Kwalipikasyon:
1.Boluntaryong nilagdaan ang form ng pahintulot na may kaalaman.
2. Relapsed/refractory na mga pasyente na may histologically o cytologically confirmed diagnosis ng advanced-stage o paulit-ulit na cancer, kabilang ang:
Pangkat A: pantog, suso, colon, gastric, melanoma, ovarian, prostate at PDAC Pangkat B: hematologic malignancies kabilang ang acute myeloid leukemia, acute lymphocytic leukemia, Diffuse large B cell lymphoma at follicular lymphoma Group C: melanoma, cervical, bladder, gastric , ulo at leeg na SCC, at lymphoma (ayon sa inaprubahang pag-label ng package ng ICI) Part 2, Group D: Ovarian cancer (2L/3L) na may baseline g9d2 T cells > 20K Part 2, Group E: metastatic castrate resistant prostate cancer (2L/3L) na may baseline g9d2 T cells > 20K Part 2, Group G: checkpoint-refractory metastatic melanoma na may g9d2 T cells >5K Part 2, Group H: chemotx-refractory o Pt-ineligible na urotherlial cancer (bladder) na may g9d2 T cells >5K Part 2, Group I: checkpoint-refractory, metastatic HNSCC na may g9d2 T cells >5K
3.Eastern Cooperative Oncology Group (ECOG) performance status < 1
4.Life expectancy > 3 months as assessed by the Investigator
5.At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or >5% marrow blasts
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