A Pharmacodynamically-Guided Dose Escalation Phase I Study to Assess the Safety of AFM13 (Recombinant Antibody Construct Against Human CD30 and CD16A) in Patients With Refractory and/or Relapsed Hodgkin Lymphoma
1. Histological diagnosis of relapsed or refractory Hodgkin lymphoma expressing the CD30
2. Age ≥18 years.
3. Both genders.
4. Patients who have relapsed or are refractory after at least two prior potentially
curative therapies including autologous stem cell transplantation (ASCT). Patients
with a progressive disease after the first-line therapy who are ineligible for, or
refused to receive high dose chemotherapy and/or ASCT for the second-line therapy, or
any other established curative therapy, are also eligible.
5. Completed radiotherapy, chemotherapy, and/or treatment with other investigational
agents at least 3 weeks prior to study entry.
6. Patients who received ASCT should have fully recovered prior to study entry.
7. Eastern Cooperative Oncology Group (ECOG) status of ≤2.
8. Laboratory data:
1. Platelet count >75,000/mm3;
2. Hemoglobin >9.0 g/dL (may be maintained by transfusion);
3. Absolute neutrophil count >1500/mm3;
4. ALT/AST (Alanine aminotransferase/Aspartate aminotransferase)<2.5 times the
upper limit of normal (ULN);
5. Total bilirubin <1.5 times ULN;
6. Creatinine <1.5 mg/dL.
9. Female patients of childbearing potential who are not surgically sterile or
postmenopausal and male patients who are not surgically sterile must agree to use
medically effective contraception during the treatment period and up to 60 days after
the last AFM13 administration. The patient must agree to sign his or her consent on
this particular inclusion criterion.
10. Ability to give written, informed consent prior to any study-specific screening
procedures, with the understanding that the consent may be withdrawn by the patient
at any time without prejudice.
11. Be willing and able to comply with the study protocol for the duration of the study.
1. Any significant diseases (other than HL (Hodgkin Lymphoma)) or clinically significant
findings, including psychiatric and behavioral problems, medical history and/or
physical examination findings that would preclude the patient from participating in
2. History or clinical evidence of central nervous system (CNS) HL.
3. Allogeneic SCT.
4. Major surgery within 4 weeks prior to study entry.
5. Known hypersensitivity to recombinant proteins or any excipient contained in the drug
6. Known history of another primary malignancy that has not been in remission for at
least 5 years. Non-concurrent non-melanoma skin cancer and cervical carcinoma in situ
or squamous intraepithelial lesions (e.g., cervical intraepithelial neoplasia [CIN]
or prostatic intraepithelial/intraductal neoplasia [PIN]) are allowed.
7. Any active viral, bacterial, or systemic fungal infection within 4 weeks prior to
8. Known to be positive for human immunodeficiency virus (HIV), hepatitis B virus
surface antigen (HBsAg), or hepatitis C virus (HCV).
9. History of significant chronic or recurrent infections requiring treatment.
10. Receiving systemic steroid prednisone or equivalent during the 3 weeks immediately
11. Pregnant or breast-feeding.