Phase I Trial of Anti-CD74 (hLL1) Antibody Therapy in B Cell Malignancies

Previous experience with antibody therapy in both NHL and CLL warrants further exploration of new antibody treatments for these diseases.

Immunomedics has developed hLL1 (previously designated EPB-1), which is a CDR-grafted, fully humanized monoclonal antibody specifically targeting CD74.38 The human IgG1 backbone for hLL1 is the same as hLL2 (epratuzumab), a monoclonal antibody whose safety has been demonstrated in clinical trials of patients with B-cell malignancies and autoimmune disorders.

This is a Phase I, open-label, study conducted in patients with recurrent non-Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL) who have progressed after at least one prior standard treatment. All patients will receive hLL1 administered intravenously once daily Monday through Friday of each of 2 consecutive weeks (10 total doses.) Patients will be assigned to a cohort for hLL1 treatment dose assignment (escalating doses of hLL1 per statistical plan) in order to determine the maximum tolerated dose (MTD) for this administration schedule.

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Key information

Conditions

Non-Hodgkin's Lymphoma Chronic Disease Chronic Lymphocytic Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Weill Cornell Medical College

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Histologically confirmed diagnosis of recurrent B cell non-Hodgkin's lymphoma or diagnosis of recurrent chronic lymphocytic leukemia
Patient has received at least one prior treatment with standard chemotherapy and at least one prior treatment with rituximab (negative HAHA test required if received prior humanized antibody treatment)
Patient has not received anti-cancer therapy within 28 days of treatment unless disease progression has been demonstrated and toxicities from prior therapy have resolved
Available tumor tissue (lymph node/mass, blood or bone marrow) for correlative analyses (paraffin or frozen, recent or archived)
Measurable disease as defined by a tumor mass > 1.5 cm in one dimension or WBC > 5,000 (CLL patients)
Age > 18 years
Patient has KPS > 50%
Absolute granulocyte count > 1000 cells/mm3
Platelet count > 50,000 cells/mm3
Creatinine < 2.0 x ULN
Total bilirubin < 2.0 x ULN
Patient agrees to use birth control if of reproductive potential
Patient has signed IRB-approved informed consent

Exclusion criteria

Known central nervous system (CNS) involvement by lymphoma
Known HIV disease
Patient is pregnant or nursing
Patient is receiving other investigational drugs
Known serum human anti-human antibodies (HAHA)
Estimated life expectancy of < 3 months

Treatment and study plan

hLL1

Drug

hLL1 administered intravenously once daily Monday through Friday for 2 consecutive weeks (10 total doses) at one of 4 planned dose levels: 1.5, 4, 6 or 8 mg/kg.

Primary outcomes

To determine the toxicity profile and maximum tolerated dose (MTD) of hLL1 when administered to patients with recurrent non-Hodgkin's lymphoma and chronic lymphocytic leukemia

Time frame: duration of study

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

Gilead Sciences

Registry information

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2015
First posted: Jul 20, 2007
Registry last updated: May 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed