Phase I Dose Escalation Study of IMMU-114 in Relapsed or Refractory NHL and CLL

Summary

IMMU-114 will be studied at different dose schedules and dose levels in order to assess the highest dose safely tolerated. IMMU-114 will be administered subcutaneously (under the skin). IMMU-114 will be given 1-2 times weekly for 3 weeks followed by one week of rest. This is considered one cycle. Treatment cycles will be repeated until toxicity or worsening of disease.

Timeline

Start

2013-03

Primary completion

2017-03

Completion

2017-03

Outcome

Outcome not reported

Stopped (Enrollment): “Study was stopped due to insufficient efficacy and very slow accrual”

Publications

• Background Park KH, Sawada T, Murakami T, Ishii Y, Yasuo M, Fuchinoue S, Goldenberg DM, Kubota K. Anti-class II -DR humanized monoclonal antibody, IMMU-114, blocks allogeneic immune response. Am J Surg. 2012 Oct;204(4):527-34. doi: 10.1016/j.amjsurg.2011.11.017. Epub 2012 Jun 1.
• Background Chen X, Chang CH, Stein R, Goldenberg DM. The humanized anti-HLA-DR moAb, IMMU-114, depletes APCs and reduces alloreactive T cells: implications for preventing GVHD. Bone Marrow Transplant. 2012 Jul;47(7):967-80. doi: 10.1038/bmt.2011.203. Epub 2011 Oct 24.
• Background Rossi EA, Rossi DL, Cardillo TM, Stein R, Goldenberg DM, Chang CH. Preclinical studies on targeted delivery of multiple IFNalpha2b to HLA-DR in diverse hematologic cancers. Blood. 2011 Aug 18;118(7):1877-84. doi: 10.1182/blood-2011-03-343145. Epub 2011 Jun 16.
• Background Stein R, Balkman C, Chen S, Rassnick K, McEntee M, Page R, Goldenberg DM. Evaluation of anti-human leukocyte antigen-DR monoclonal antibody therapy in spontaneous canine lymphoma. Leuk Lymphoma. 2011 Feb;52(2):273-84. doi: 10.3109/10428194.2010.535182. Epub 2010 Dec 6.
• Background Stein R, Gupta P, Chen X, Cardillo TM, Furman RR, Chen S, Chang CH, Goldenberg DM. Therapy of B-cell malignancies by anti-HLA-DR humanized monoclonal antibody, IMMU-114, is mediated through hyperactivation of ERK and JNK MAP kinase signaling pathways. Blood. 2010 Jun 24;115(25):5180-90. doi: 10.1182/blood-2009-06-228288. Epub 2010 Jan 25.

Drugs

Indications