This phase 1/2 clinical trial will test the response to AFM13 in patients with relapsed or refractory cutaneous (on the skin) CD30 positive lymphomas. The primary outcome will be measured by immune system activity. This study will be conducted at the Center for Lymphoid Malignancies in New York, New York.
The details
AFM13 is an immunotherapy that uses the body’s own immune system to identify and kill cancerous B and T-cells. It is an antibody (a protein in the immune system) that binds to a protein found on certain types of cancerous immune cells. This allows other parts of the immune system to identify the malignant cells and initiate an attack. This therapy has the potential to promote a full-body immune response against cancerous B and T-cells.
The study will examine the immune system’s attacks on the cancer cells, number of immune cells, and level of immune system signaling for up to 2 years. The study will also observe the number of adverse (negative) side effects, response to treatment, and time to disease progression for up to 2 years.
Who are they looking for?
This trial is recruiting 18 patients with relapsed or refractory cutaneous CD30 positive lymphoma who have received prior treatment. Participants should have adequate organ and bone marrow function. Participants should present with at least one cancerous lesion on the skin.
Ideal candidates should not have received anticancer treatment or any major surgery within 2 weeks prior to entry. Patients with a history of previous malignancies must be disease free for at least 3 years. Participants should not have symptomatic or uncontrolled heart conditions within 6 months prior to treatment. Male and female participants must agree to use contraception for up to 30 days following treatment.
How will it work
Patients will be separated into 6 groups. Each group will receive specified doses of AFM13 intravenously (through IV into a vein) at given times for 8 weeks.
Group 1 will be given AFM13 once a week for weeks 1-8. Group 2 will receive AFM13 three times a week for weeks 1-8. Group 3 will receive a low dose of AFM13 three times a week during weeks 1 and 2 then a high dose once a week for weeks 3-8. Group 4 will receive AFM13 three times a week during weeks 1 and 2 then a high dose once a week for weeks 3-8. Group 5 will be given a high dose of AFM13 once a week for weeks 1-8. Group 6 will be given a mid-high dose three times a week for the first 2 weeks then a high dose once a week during week 3-8.
