MPN-RC 118 AVID200 in Myelofibrosis

  • STATUS
    Recruiting
  • End date
    Mar 25, 2023
  • participants needed
    24
  • sponsor
    John Mascarenhas
Updated on 25 January 2021
platelet count
cancer
anemia
myelofibrosis
hydroxyurea
ruxolitinib
serum pregnancy test
direct bilirubin
iv infusion
thrombocytopenia
total abstinence
conjugated bilirubin
bone marrow biopsy
red blood cell transfusion
hematoma
essential thrombocythemia
thrombocytosis
polycythemia
avid200
thrombocythemia

Summary

Increased levels of TGF-1 were detected in serum, plasma and BM and positively correlated with both grade of BMF and extent of leukemic cell infiltration in the marrow. TGF- likely plays a dual role in promoting myelofibrosis and myeloproliferation, both of which are the bone marrow morphologic hallmark of MF. AVID200 is a drug that targets TGF-1 and TGF-3. The study team hypothesizes that inhibiting the TGF- signaling pathway in MF will decrease the fibrogenic stimuli leading to myelofibrosis and concomitantly interrupt myeloproliferation and restore normal hematopoiesis.

This is a first in human, open-label, multicenter, Phase I/Ib trial of AVID200. Patients must have intermediate-2 or higher primary myelofibrosis (PMF), post-essential thrombocythemia or polycythemia-vera related MF (Post ET/PV MF). This study will enroll up to 24 patients. AVID200 is delivered by IV infusion on day 1 of each 3 week cycle.

Description

This is a first in human, open-label, multicenter, Phase I/Ib trial of AVID200. To date, there is no therapy for MF evaluated in the clinic that clearly demonstrates the ability to target the malignant HSC and result in effective and reproducible bone marrow morphologic, cytogenetic and molecular responses. Medicinal therapies that result in disease course modification are urgently needed in this chronic and progressive myeloid malignancy. TGFlikely plays a dual role in promoting myelofibrosis and myeloproliferation, both of which are the bone marrow morphologic hallmark of MF. The study team proposes that inhibiting the TGFsignaling pathway in MF will decrease the fibrogenic stimuli leading to myelofibrosis and concomitantly interrupt myeloproliferation and restore normal hematopoiesis. AVID200 is a fusion protein containing TGF- receptor ectodomains fused to a human Fc IgG domain. AVID200 is a potent TGF trap with antibody-like properties which has pM potency against two of the three TGF ligands, TGF1 and 3.

Details
Condition Myelosclerosis with myeloid metaplasia, Post-PV MF, Post Essential Thrombocythemia Myelofibrosis, Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post ET MF, Post PV MF, Post-polycythemia Vera Myelofibrosis, Post Polycythemia Vera Myelofibrosis
Treatment AVID200
Clinical Study IdentifierNCT03895112
SponsorJohn Mascarenhas
Last Modified on25 January 2021

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