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A Safety Study of SGN-40 in Patients With Non-Hodgkin's Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Safety Study of SGN-40 in Patients With Non-Hodgkin's Lymphoma

A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Non-Hodgkin's Lymphoma

NCT00103779•Seagen Inc.

Summary

This is an open-label, multi-dose, Phase I, dose escalation study to define the safety profile and preliminary anti-tumor activity of SGN-40 in patients with refractory or recurrent non-Hodgkin B-cell lymphomas.

Detailed Description

A minimum of 3 patients will be entered into each dose-level cohort for 5 weeks. A dose-escalation schema will be employed in cohorts. The initial dose starts at 1 mg/kg on Day 1 and 4 followed by 2mg/kg on Day 8. Dose escalation will occur on weeks 3-5 with a maximum weekly dose of 8 mg/kg. Patients who meet criteria of at least partial response will be eligible for additional 4 weekly doses at highest dose tolerated.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have a histological diagnosis of B cell non-Hodgkin's lymphoma, including diffuse large B-cell, mantle cell, follicular, small lymphocytic, and marginal zone lymphoma by the World Health Organization criteria.
•Patients must have an archived paraffin or fresh tumor specimen available for immunohistologic evaluation of CD40, CD20, \& CD79a.
•Patients must have relapsed lymphoma and must have failed frontline chemotherapy.
•Patients who have not received autologous stem cell transplant must have refused or be ineligible for it.
•Patients must have completed radiotherapy, chemotherapy, and/or treatment with investigational anti-cancer agents 4 weeks prior to registration. Patients must have completed any monoclonal antibody treatment, including rituximab, 6 months prior to registration.
•Patients must have completed autologous bone marrow transplant 4 months prior to registration.
•Patient must have at least one site of measurable disease defined by unidimensional lesion ≥ 2 cm by conventional CT scan.
•Patients must have an ECOG performance status ≤ 2 and a life expectancy \> 3 months.
•Patients must have the following required baseline laboratory data:
•* Platelet count ≥ 75,000/mm3,
+9 more criteria

Exclusion Criteria

•Patients with history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma.
•Patients with a documented history within 6 months of registration of a cerebral vascular event, myocardial infarction, deep venous thrombosis or other vascular event that has required medical or surgical intervention. Patients must have completed anticoagulant therapy at least 3 months prior to registration. Prophylactic anticoagulant therapy for indwelling catheters is acceptable.
•Patients who have received an allogeneic stem cell transplant.
•Patients who have had major surgery within 4 weeks prior to registration.
•Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
•Patients with a history of another primary malignancy that has not been in remission for at least 5 years (non-melanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear are exempt from the five year limit).
•Patients with any active systemic viral, bacterial, or fungal infection within four weeks prior to registration.
•Patients with known positivity for HIV, hepatitis B or hepatitis C infection.
•Patients with a history of significant chronic or recurrent infections requiring treatment.
•Patients with a history of migraines or severe headaches requiring medical therapy within 12 months of enrollment.
+4 more criteria

Locations (5)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Stanford University

Stanford, California, United States

University of Miami

Miami, Florida, United States

Cornell University

New York, New York, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

December 1, 2004

Primary Completion Date

March 1, 2007

Completion Date

March 1, 2007

Last Updated

December 18, 2014

Enrollment

ACTUAL participants

Conditions

Non-Hodgkin Lymphoma

Interventions

SGN-40 (anti-huCD40 mAb)

DRUG

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

NCT06189391

Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

View study

RECRUITINGPHASE1/PHASE2

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716

B-cell MalignancyMarginal Zone Lymphoma+7 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Safety Study of SGN-40 in Patients With Non-Hodgkin's Lymphoma

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

A Study to Assess Safety and Efficacy of CHO-H01 as a Single Agent/Combined With Lenalidomide in Subjects With Refractory or Relapsed Non-Hodgkin's Lymphoma

A Study of (LY3527727) Pirtobrutinib in Participants With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma

Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma