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Report for Clinical Trial NCT02252146

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase I/II Open-label, Multiple-dose, Dose-escalation Study to Evaluate the Safety and Tolerability of IMO-8400 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Presence of the MyD88 L265P Mutation

Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 30% of the patients with the activated B-cell (ABC) type of Diffuse Large B Cell Lymphoma (DLBCL). MYD88 is an initial adapter linker protein in the signaling pathway of the Toll Like Receptors (TLRs), including the endosomal TLRs 7, 8, and 9, for which the ligands are nucleic acids. IMO-8400 is an oligonucleotide specifically designed to inhibit ligand activation of TLRs 7,8, and 9. Recent studies indicate that in the presence of L265P mutation ligand activation of those TLRs results in markedly increased signaling with subsequent increased cell activation, cell survival, and cell proliferation. The scientific rationale for assessing the use of IMO-8400 to treat patients with DLBCL and the L265P mutation is based on laboratory observations that IMO-8400 inhibits ligand-based activation of cells with the mutation and decreases the survival and proliferation of the cell populations responsible for the propagation of the disease.

NCT02252146 Diffuse Large B Cell Lymphoma
MeSH:Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse
HPO:B-cell lymphoma Lymphoma

1 Interventions

Name: IMO-8400

Description: MO-8400 given subcutaneously twice weekly
Type: Drug
Group Labels: 1

IMO-8400


Primary Outcomes

Description: Frequency of adverse events, injection site reactions, and concomitant medications observed

Measure: Number of Participants With Adverse Events, Injection Site Reactions, and Concomitant Medications

Time: Up to 2 years from first patient visit

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L265P

Phase I/II Open-label, Multiple-dose, Dose-escalation Study to Evaluate the Safety and Tolerability of IMO-8400 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Presence of the MyD88 L265P Mutation. --- L265P ---

Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 30% of the patients with the activated B-cell (ABC) type of Diffuse Large B Cell Lymphoma (DLBCL). --- L265P ---

Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 30% of the patients with the activated B-cell (ABC) type of Diffuse Large B Cell Lymphoma (DLBCL). --- L265P --- --- L265P ---

IMO-8400 is an oligonucleotide specifically designed to inhibit ligand activation of TLRs 7,8, and 9. Recent studies indicate that in the presence of L265P mutation ligand activation of those TLRs results in markedly increased signaling with subsequent increased cell activation, cell survival, and cell proliferation. --- L265P ---

The scientific rationale for assessing the use of IMO-8400 to treat patients with DLBCL and the L265P mutation is based on laboratory observations that IMO-8400 inhibits ligand-based activation of cells with the mutation and decreases the survival and proliferation of the cell populations responsible for the propagation of the disease. --- L265P ---

Inclusion Criteria: - Patients must have a diagnosis of Diffuse Large B Cell Lymphoma (DLBCL) of non-GCB subtype, established according to the World Health Organization (WHO) criteria that has been tested for the MyD88 L265P mutation. --- L265P ---

Being treated with other anti-cancer therapies (approved or investigational) 7. Has an active infection requiring systemic antibiotics 8. Has had surgery requiring general anesthesia within 4 weeks of starting the study 9. Has heart failure of Class III or IV Inclusion Criteria: - Patients must have a diagnosis of Diffuse Large B Cell Lymphoma (DLBCL) of non-GCB subtype, established according to the World Health Organization (WHO) criteria that has been tested for the MyD88 L265P mutation. --- L265P ---



HPO Nodes


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