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TL-895

DRUG9 trials

Sponsors

Telios Pharma Inc., Telios Pharma Inc., Telios Pharma Inc., Telios Pharma, Inc., Kartos Therapeutics, Inc.

Conditions

Acute Myeloid LeukemiaB Cell Malignancies and Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaBlood CancerCOVID-19CancerCarcinomaChronic Lymphocytic LeukemiaIndolent Systemic Mastocytosis

Phase 1

Phase I/II, FIH, Dose Escalation Trial of TL-895 and Expansion of TL-895 Monotherapy and Combination Therapy With Navtemadlin in Tx-Naïve and R/R CLL/SLL Subjects
NCT02825836
Telios Pharma, Inc.Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma and Diffuse Large B Cell Lymphoma, Relapsed/Refractory B Cell Malignancies +2
Start: 2016-08-26End: 2025-12-01Target: 130Updated: 2023-07-13
A Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer
CompletedNCT04419623
Telios Pharma, Inc.Blood Cancer, Cancer, Carcinoma +3
Start: 2020-07-09End: 2020-12-15Updated: 2021-05-12
KRT-232 in Combination With TL-895 for the Treatment of R/R MF and KRT-232 for the Treatment of JAKi Intolerant MF
NCT04640532
Kartos Therapeutics, Inc.Myelofibrosis, Post-ET Myelofibrosis, Post-PV MF +1
Start: 2020-11-17End: 2025-07-24Target: 116Updated: 2022-05-09
TL-895 and KRT-232 Study in Acute Myeloid Leukemia
NCT04669067
Telios Pharma, Inc.Acute Myeloid Leukemia
Start: 2021-03-31End: 2025-11-30Updated: 2023-02-17
Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib
RecruitingNCT05280509
Telios Pharma, Inc.Myelofibrosis, Post-ET Myelofibrosis, Post-PV MF +1
Start: 2022-06-09End: 2027-04-30Target: 70Updated: 2023-02-21
Phase I/II, First in Human, Dose Escalation Trial of TL-895 Monotherapy in Subjects with Relapsed/Refractory B-Cell Malignancies and Expansion of TL-895 Monotherapy and Combination Therapy with Navtemadlin in Treatment-Naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Subjects and Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia or Relapsed/Refractory Small Lymphocytic Lymphoma
CompletedCTIS2024-516691-14-00
Telios Pharma Inc., Telios Pharma Inc.B Cell Malignancies and Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Start: 2021-01-05End: 2025-07-30Target: 69Updated: 2025-05-09

Phase 2

Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
RecruitingNCT04655118
Telios Pharma, Inc.Indolent Systemic Mastocytosis, Myelofibrosis
Start: 2020-10-22End: 2025-12-31Target: 121Updated: 2024-05-10
Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
NCT04878003
Kartos Therapeutics, Inc.Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF), Post-Polycythemia Vera Myelofibrosis (Post-PV-MF), Primary Myelofibrosis (PMF)
Start: 2021-04-13End: 2025-10-31Target: 52Updated: 2022-05-09
A Phase 2 Multicenter Study of TL-895 in Subjects with Myelofibrosis, Indolent Systemic Mastocytosis, Monoclonal Mast Cell Activation Syndrome, or Non-Monoclonal Mast Cell Activation Syndrome
Active, not recruitingCTIS2024-514467-26-00
Telios Pharma Inc.Indolent Systemic Mastocytosis
Start: 2021-04-07Target: 143Updated: 2025-12-23

Related Papers

A Phase (Ph) 2 Study of TL-895, a Highly Selective, Novel Covalent BTK Inhibitor (BTKi), in Patients (pts) with Treatment-Naïve (TN) and Relapsed/Refractory (R/R) BTKi-Naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Blood2023-11-023 citations
TL-895, a Highly Selective, Covalent Inhibitor of Bruton's Tyrosine Kinase (BTK), Sensitizes Myeloproliferative Neoplasm (MPN)-Blast Phase Stem Cells to Navtemadlin By Targeting Intrinsic Dysregulated MDM2/p53 and NF-Κb Pathways and Disrupting the Protective Tumor Microenvironment (TME)
Blood2023-11-021 citations
P1038: TL-895, A FIRST-IN-CLASS, COVALENT BRUTON TYROSINE KINASE INHIBITOR (BTKI) FOR THE TREATMENT OF MYELOFIBROSIS (MF) PATIENTS (PTS) WITH SEVERE THROMBOCYTOPENIA (PLATELETS (PLTS) <50 K/UL)
HemaSphere2023-08-011 citations
P1006: CHARACTERIZATION OF TL-895: A NOVEL BRUTON TYROSINE KINASE INHIBITOR (BTKI) IN CLINICAL DEVELOPMENT FOR CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND MYELOFIBROSIS (MF)
HemaSphere2023-08-011 citations
P1005: EFFECT OF TL-895, A NOVEL BRUTON’S TYROSINE KINASE INHIBITOR (BTKI), ON ONCOGENIC JANUS KINASE 2-V617F (JAK2VF) SIGNALING
HemaSphere2023-08-01
PB2198: TRIAL IN PROGRESS: AN OPEN-LABEL, GLOBAL, MULTICENTER, PHASE 1B/2 STUDY OF TL-895, A BRUTON’S TYROSINE KINASE INHIBITOR (BTKI), ADDED TO RUXOLITINIB (RUX) IN PATIENTS (PTS) WITH MYELOFIBROSIS (MF)
HemaSphere2023-08-01
Phase I, first-in-human trial of Bruton’s tyrosine kinase inhibitor M7583 in patients with B-cell malignancies
Leukemia & lymphoma/Leukemia and lymphoma2021-04-245 citations
A Phase I/II, First in Human Trial of the Bruton's Tyrosine Kinase Inhibitor M7583 in Patients with B-Cell Malignancies
Blood2018-11-293 citations
Phase I/II, first in human trial with M7583, a Bruton’s tyrosine kinase inhibitor (BTKi), in patients with B cell malignancies
Annals of Oncology2018-10-013 citations
First in Human, Phase I/II Trial of the Bruton's Tyrosine Kinase Inhibitor (BTKi) M7583 in Patients with B Cell Malignancies: Study Design and Initial Outcomes
Blood2017-12-073 citations
Phase I/II, first in human trial of the Bruton’s tyrosine kinase inhibitor (BTKi) M7583 in patients with B cell malignancies.
Journal of Clinical Oncology2017-05-202 citations