Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma

Study Overview
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Brief Summary
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This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with bendamustine in patients with follicular lymphoma.

Official Title
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A Phase Ib, Multicenter, Open-label Study of HCD122 Administered Intravenously in Combination With Bendamustine in Patients With CD40+ Follicular Lymphoma Who Are Refractory to Rituximab

Conditions
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Follicular Lymphoma

Intervention / Treatment
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* Drug: HCD122


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of follicular lymphoma, according to the Revised European American Lymphoma/World Health Organization [REAL/WHO] classification Documented CD40+ follicular lymphoma Measurable lesion Refractory to rituximab Prior treatment with at least 1 chemotherapeutic regimen 18 years or older WHO Performance Status grade 0, 1, or 2 Life expectancy > 3 months Obtained written informed consent Exclusion Criteria: Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma (i.e. DLBCL) History of another primary malignancy that is currently clinically significant or currently requires active intervention Prior allogeneic stem cell transplantation Prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration Impaired cardiac function or clinically significant cardiac disease History of acute or chronic pancreatitis, surgery of the pancreas, or any risk factors that may increase the risk of pancreatitis History of an active infection (viral, bacterial, or fungal) requiring systemic therapy within 28 days before study treatment. Known diagnosis of human immunodeficiency virus (HIV) infection Evidence of previous hepatitis viral infection such as hepatitis B or hepatitis C Ongoing corticosteroid use (>10 mg/day prednisone or equivalent) Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCD122<br> | Drug: HCD122<br> <br> * Other names: Lucatumumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of dose-limiting toxicities and adverse events |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCD122, Lucatumumab, CD40, Follicular Lymphoma, Non-Hodgkin's Lymphoma, Antibody