Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies

Study Overview
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Brief Summary
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This study is to evaluate the highest tolerated dose, safety and activity of HCD122 in adults with non-Hodgkin's or Hodgkin's lymphoma who have received at least two prior therapies.

Official Title
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A Phase IA/II, Multi-center, Open-label Study of HCD122 Administered Intravenously Once Weekly for Four Weeks in Adult Patients With Advanced Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies (CHIR-12.12-LYM-01)

Conditions
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Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: HCD122


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients may be included in the study if they meet all of the following criteria: Patients must have confirmed diagnosis of HL or NHL (follicular, marginal zone / MALT, diffuse large B-cell, or mantle cell) per REAL/WHO classification Patients must have progressed after at least 2 prior therapies (autologous stem cell transplantation is considered as 1 therapy) Patients must be ≥ 18 years Patients must have life expectancy > 3 months Patient must have adequate laboratory results Patients must have WHO Performance Status grade 0, 1, or 2 Patients must have at least one site of measurable disease Patients must have discontinued any previous monoclonal antibody or radioimmunotherapy, and must have recovered fully from the side effects of that treatment prior to beginning study treatment. Patients must be willing and able to sign the informed consent form and comply with the study protocol Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: Patients who have been treated with any anti-CD40 antibody Patients who have received prior allogeneic stem cell transplant Patients who have had a prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration Patients who have history or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis Women of child-bearing potential (WCBP) who are pregnant or breast feeding. 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 |
| --- | --- |
| Other: HCD122<br> | Drug: HCD122<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoints (phase I) - Incidence rate of DLT and AE |  | 2 years | 
| Primary endpoint (phase II) - Response rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCD122, NHL, HL, CD40