A Safety Study of SGN-CD19A for B-Cell Lymphoma

Study Overview
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Brief Summary
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This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin lymphoma (B-NHL)

Official Title
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A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma

Conditions
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Burkitt Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Precursor B-cell Lymphoblastic Leukemia-Lymphoma

Intervention / Treatment
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* Drug: SGN-CD19A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma Grade 3, diffuse large B-cell lymphoma (DLBCL), including transformed follicular histology, Burkitt lymphoma, or B-lineage lymphoblastic lymphoma Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy. Patients with DLBCL or follicular lymphoma Grade 3 must have also received intensive salvage therapy. Eastern Cooperative Oncology Group status of 0 or 1 Measurable disease Exclusion Criteria: Allogeneic stem cell transplant (SCT)

Ages Eligible for Study
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Minimum Age: 12 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGN-CD19A<br>SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks) | Drug: SGN-CD19A<br>* SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Through 1 month post last dose | 
| Incidence of laboratory abnormalities |  | Through 1 month post last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response according to revised response criteria for malignant lymphoma (Cheson 2007) |  | Through up to approximately 6 week post last dose | 
| Duration of response |  | Until disease progression or start of new anticancer treatment, an expected average of 6 months | 
| Overall survival |  | Until death or study closure, an expected average of 1 year | 
| Blood concentration of SGN-CD19A and metabolites |  | Through up to approximately 6 weeks post last dose | 
| Incidence of antitherapeutic antibodies |  | Through up to approximately 6 weeks post last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD19, B-Lineage Lymphoblastic Lymphoma, Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, B-Cell Lymphoma, Drug Therapy, Monomethylauristatin F, Follicular Lymphoma Grade 3