- Percentage of Intratumoral NK-cells and T-cells infiltration into tumors [ Time Frame: Up to 2 years ]
Quantified by multiplex Immuno-histochemistry (IHC) using tissue samples
- Number of immune cells (NK cells, T cells, and others) in tumor and peripheral blood [ Time Frame: Up to 2 years ]
Measured by multi-color flow cytometry and immunophenotyping technique
- Level of plasma cytokine production plus release in tumor and peripheral blood as a function of treatment [ Time Frame: Up to 2 years ]
Elisa test will be used to measure cytokine levels
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 2 years ]
Incidence of Treatment-Emergent Adverse Events [Safety and Toxicity] broken down by adverse event and CTCAE v4.0 grade of each event.
- Overall Response Rate (ORR) [ Time Frame: Up to 2 years ]
The sum of patients with partial responses and complete responses.
- Duration of Response (DOR) after treatment with AFM 13 [ Time Frame: Up to 2 years ]
The time of initial response until documented tumor progression.
- Progression Free Survival (PFS) after treatment with AFM 13 [ Time Frame: Up to 2 years ]
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
This is an open label, Phase Ib/IIa study designed to evaluate the biologic activity of AFM13 in patients with relapsed or refractory CD30-positive lymphomas with cutaneous involvement. Primary cutaneous CD30-positive lymphoproliferative disorders (LPD) represent a spectrum from lymphomatoid papulosis (LyP), to primary cutaneous anaplastic large cell lymphoma (C-ALCL), to transformed mycosis fungoides (TMF).
The most indolent form of primary cutaneous CD30-positive LPD is LyP, which is usually well controlled with low dose oral methotrexate, but control of the disease frequently requires life-long therapy. In contrast, TMF is an aggressive disease which does not have a standard of care, as patients are treated with various modalities of care with variable outcomes). The spectrum of other CD30-positive lymphomas with cutaneous presentation is very broad and involves systemic B and T cell lymphomas with various clinical behaviors.
Redirecting Natural Killer (NK) cells towards these CD30-positive malignancies through direct engagement with AFM13 is expected to induce tumor cell killing through NK cell-mediated and T cell-mediated cytotoxicity (i.e., cytotoxic T lymphocytes (CTL)).
The primary objective of this trial is to study the biologic and immunologic effects induced by the administration of various doses of AFM13, when given as a single agent.