HuMax-CD4 (Zanolimumab), a Fully Human Monoclonal Antibody: Early Results of an Ongoing Clinical Trial in CD4⁺ Peripheral T-Cell Lymphoma of Non-Cutaneous Type.

HuMax-CD4 (zanolimumab) is a fully human monoclonal IgG1k antibody, targeting the CD4 molecule on T-cells. It exhibits cytotoxic and anti-proliferative effects and has previously shown efficacy in cutaneous T-cell lymphoma. We report initial clinical efficacy and safety of treatment with 980 mg of HuMax-CD4 in 8 patients diagnosed with biopsy-proven, treatment-refractory or relapsed CD4⁺ peripheral T-cell lymphoma (PTCL) of non-cutaneous type. Patients were enrolled with the following diagnoses; enteropathy-type T-cell lymphoma (n=1), anaplastic large T-cell lymphoma (n=3, 2 ALK⁻ subtype, 1 unknown), angioimmunoblastic T-cell lymphoma (n=1) and PTCL, unspecified (n=3). Primary endpoint was objective tumor response. Responses were based on CT scan and clinical examination and classified according to the Cheson criteria. Out of the 8 patients enrolled, 2 responses have been seen; 1 PR and 1 CRu (verified by CT scan). Further, clinical improvements (marked decrease in the size of peripheral lymph nodes) were recorded by the physicians in 3 other patients. In total, 9 SAEs have been reported. Of these, 1 case of febrile neutropenia was judged related. 8 unrelated SAEs were recorded; knee pain, viremia (n=2), condition aggravated, and disease progression (n=4). Three unrelated deaths have been reported, all due to disease progression. In conclusion, HuMax-CD4 was well tolerated in heavily pre-treated patients and the present results indicate efficacy in the treatment of PTCL.