Topics

A Safety and Pharmacokinetic Study of IGM-2323 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma

2019-09-13 02:15:40 | BioPortfolio

Summary

This is a Phase 1 study of IGM-2323 in adult subjects with relapsed or refractory B-cell Non-Hodgkin Lymphoma. This study will consist of a dose-escalation stage and a dose-expansion stage where subjects will be enrolled into indication-specific expansion cohorts. IGM-2323 will be administered intravenously (IV).

Additional CD20-positive NHL histologies (e.g. MZL and MCL), may be allowed with Medical Monitor approval during the Dose-Escalation Phase of the study.

Description

IGM-2323 is an engineered bispecific IgM antibody for the treatment of patients with CD20-positive cancers. It contains ten high affinity binding domains for CD20, and one binding domain for CD3. IGM-2323 is able to eliminate CD20-positive lymphoma cells by engaging T-cells and lymphoma cells, leading to T-cell dependent cellular cytotoxicity. Additionally, IGM-2323 is also able to eliminate lymphoma cells by recruiting complement to the surface of lymphoma cells, leading to complement dependent cytotoxicity.

In our preclinical studies, we observed activity against rituximab resistant cells carrying low levels of CD20. We have also observed much lower cytokine release with IGM-2323 relative to comparable IgG format bispecific T-cell engaging antibodies, which is expected to result in reduced risk of the serious adverse effects from cytokine release syndrome (CRS).

Study Design

Conditions

Non-Hodgkin Lymphoma

Intervention

IGM-2323, IGM-2323

Location

Honor Health Research Institute
Phoenix
Arizona
United States
85258

Status

Recruiting

Source

IGM Biosciences, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-13T02:15:40-0400

Clinical Trials [2204 Associated Clinical Trials listed on BioPortfolio]

Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma

This clinical trial is for patients with Hodgkin Lymphoma that has not responded to standard treatment. The purpose of this study is to determine what effects, good or bad, Temsirolimus h...

Study of LBH589, A Deacetylase Inhibitor in Patients With Recurrent or Refractory Hodgkin or Non-Hodgkin's Lymphoma

The purpose of this study is to find out the effects of a drug called LBH589 when given to people with recurrent or refractory Hodgkin or Non-Hodgkin's lymphoma. The safety of this drug w...

Chidamide Combined With Clad/Gem/Bu With AutoSCT in High Risk Hodgkin & Non-Hodgkin Lymphoma

This study is to explore the efficacy and safety of ChiCGB conditioning therapy in patients with high-risk Hodgkin and non-Hodgkin lymphoma.

Quality of Life Among Survivors of Hodgkin Lymphoma

The purpose of this study is to collect information on the long-term side effects of treatment for Hodgkin Lymphoma. We hope to study about 500-800 survivors of Hodgkin Lymphoma. We plan t...

Treatment of Non-Hodgkin's Lymphoma With 90Y-hLL2 IgG

The purpose of this trial is to determine the safety of a 90Y-radiolabeled, humanized (CDR-grafted) form of the LL2 monoclonal antibody in patients with Non-Hodgkin's lymphoma (NHL) at dif...

PubMed Articles [905 Associated PubMed Articles listed on BioPortfolio]

Gallbladder non-Hodgkin's lymphoma: Case report.

Extrahepatic biliary non-Hodgkin's lymphoma (EBNHL) is rare, with a prevalence of 0.6% of malignant biliary tumors. Primary biliary non-Hodgkin's lymphoma accounts for 0.4% of extranodal non-Hodgkin's...

The Lymphoma-Associated Macrophage to Hodgkin-Reed-Sternberg Cell Ratio Is a Poor Prognostic Factor in Classic Hodgkin Lymphoma Patients.

Despite the relatively high rate of curability, approximately 20% to 30% of patients with classic Hodgkin lymphoma relapse. Hodgkin-Reed-Sternberg (HRS) cells:lymphoma-associated macrophages (LAMs) cr...

CD30+ large B cell lymphoma with anaplastic features and complete loss of B cell marker expression arising from follicular lymphoma.

Follicular lymphoma is the most common indolent B cell lymphoma, accounting for 20% of all non-Hodgkin lymphomas. Transformation of follicular lymphoma to a more aggressive lymphoma is a well-characte...

Treatment of Hodgkin lymphoma. Analysis of 915 patients.

Hodgkin lymphoma has a high rate of curability, even in advanced stages.

Specific infiltrate of Hodgkin lymphoma at site of cellulitis mimicking secondary cutaneous involvement.

Hodgkin lymphoma usually involves the lymph nodes, but concomitant cutaneous manifestations might be present. The diagnosis of cutaneous involvement by Hodgkin lymphoma must be supported by specific c...

Medical and Biotech [MESH] Definitions

Two or more distinct types of malignant lymphoid tumors occurring within a single organ or tissue at the same time. It may contain different types of non-Hodgkin lymphoma cells or both Hodgkin and non-Hodgkin lymphoma cells.

A form of non-Hodgkin lymphoma having a usually diffuse pattern with both small and medium lymphocytes and small cleaved cells. It accounts for about 5% of adult non-Hodgkin lymphomas in the United States and Europe. The majority of mantle-cell lymphomas are associated with a t(11;14) translocation resulting in overexpression of the CYCLIN D1 gene (GENES, BCL-1).

Any of a group of malignant tumors of lymphoid tissue that differ from HODGKIN DISEASE, being more heterogeneous with respect to malignant cell lineage, clinical course, prognosis, and therapy. The only common feature among these tumors is the absence of giant REED-STERNBERG CELLS, a characteristic of Hodgkin's disease.

Clinically benign, histologically malignant, recurrent cutaneous T-cell lymphoproliferative disorder characterized by an infiltration of large atypical cells surrounded by inflammatory cells. The atypical cells resemble REED-STERNBERG CELLS of HODGKIN DISEASE or the malignant cells of CUTANEOUS T-CELL LYMPHOMA. In some cases, lymphomatoid papulosis progresses to lymphomatous conditions including MYCOSIS FUNGOIDES; HODGKIN DISEASE; CUTANEOUS T-CELL LYMPHOMA; or ANAPLASTIC LARGE-CELL LYMPHOMA.

A systemic, large-cell, non-Hodgkin, malignant lymphoma characterized by cells with pleomorphic appearance and expressing the CD30 ANTIGEN. These so-called "hallmark" cells have lobulated and indented nuclei. This lymphoma is often mistaken for metastatic carcinoma and MALIGNANT HISTIOCYTOSIS.

More From BioPortfolio on "A Safety and Pharmacokinetic Study of IGM-2323 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma"

Quick Search

Relevant Topic

Hodgkin lymphoma
Hodgkin Lymphoma is a  disorder caused by malignant proliferation of lymphocytes, which contain characteristic mirror-image nuclei (Reed-Sternburg cells). The resulting lymphadenopathy can be limited to a single lymph node region (Stage 1) or spread...


Searches Linking to this Trial