Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Rare Diseases

Leukemia

Lymphoma, Large B-Cell, Diffuse

Leukemia, Lymphoid

Lymphoma

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Follicular

Lymphoma, B-Cell

Aggression

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Follicular Lymphoma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Muromonab-CD3

Administered by intravenous (IV) infusion

Odronextamab multiple dose levels

Administered by subcutaneous (SC) injection

Clinical Trial Management

This study has two parts with distinct study objectives and study design. In part A, odronextamab is studied as an intravenous (IV) administration with a dose escalation and a dose expansion phase for B-NHL and CLL. The dose escalation phase for B-NHL and the CLL study are closed at the time of protocol amendment 17. In part B, odronextamab is studied as a subcutaneous (SC) administration with a dose finding and a dose expansion phase for B-NHL.

Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies

An Open-Label, Multi-Center Phase 1 Study to Investigate the Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With CD20+ B-Cell Malignancies Previously Treated With CD20-Directed Antibody Therapy (ELM-1)

Expansion Cohorts:

• Diffuse large B-cell lymphoma (DLBCL) after failure of CAR-T therapy

Part A

Peak plasma concentration (Cmax) of odronextamab

Part A and B

For dose escalation portion and expansion cohorts:

* Aggressive lymphoma expansion cohort 2
* FL grade 1-3a expansion cohorts 1 and 2 (Part A)

For dose escalation and dose expansion cohorts:

* FL grade 1-3a
* DLBCL
* DLBCL post CAR T failure (Part B)

Regeneron Pharmaceuticals

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies	NCT02290951	Non-Hodgkin Lym... Chronic Lymphoc...	Odronextamab mu... Odronextamab mu...	18 Years -	Regeneron Pharmaceuticals
Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies	NCT02290951	Non-Hodgkin Lym... Chronic Lymphoc...	Odronextamab mu... Odronextamab mu...	18 Years -	Regeneron Pharmaceuticals

Spots Global Cancer Trial Database for odronextamab multiple dose levels