Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides
Conditions
Interventions
Product Name: AFM13
Product Code: AFM13
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Not applicable
Curren
Sponsors
Affimed GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent in accordance with federal, local, and institutional guidelines. 2. Age =18 years at time of provision of informed consent. 3. Histologically confirmed CD30-positive (via Ber-H2 targeted assay;cut-offs listed in protocol) PTCL (allowed subtypes listed in protocol) or TMF per the revised WHO 2016 classification (Swerdlow, 2016) by central assessment. The required cut-offs for the CD30-positivity are: • Cohort A (PTCL): =10% by IHC • Cohort B (PTCL): =1 to 1,000/mm3; d) Alanine transaminase/aspartate transaminase =3 x the upper limit of normal (ULN) or =5 x for patients with documented hepatic involvement with lymphoma; e) Total bilirubin =1.5 x ULN or 1.5 x ULN; 11. If female of child-bearing potential, must not be pregnant or be breastfeeding and required to have a negative urine or serum pregnancy test within 3 days prior to the first dose of study drug. Note: Urine pregnancy tes
Exclusion criteria
Exclusion criteria: 1. Patients with the following subtypes of lymphoma: •T-cell prolymphocytic leukemia •T-cell large granular lymphocytic leukemia •Chronic lymphoproliferative disorder of NK cells •Aggressive NK-cell leukemia •Extranodal NK-/T-cell lymphoma (ATLL). •Indolent T-cell lymphoproliferative disorder of the GI tract 2. Current evidence of central nervous system involvement. 3. Has had an allogenic tissue hematopoietic cell/solid organ transplant within the last 3 years. Note: Patients who have had a transplant 3 years ago are eligible as long as there are no signs/symptoms of graft versus host disease (GvHD). 4. Requirement for systemic immunosuppressive therapy e.g. GvHD therapy, <12 weeks prior to the first dose of study drug. 5. Major surgery =4 weeks prior to first dose of study drug. 6. Any active, concurrent, significant illness or disease (other than T-cell lymphoma) or clinically significant findings including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the patient from participation in the study such as: a) active infection requiring systemic therapy =10 days before the first dose of study drug; b) unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association [NYHA] II, III, IV; Appendix C of protocol). C), myocardial infarction =6 months prior to first study drug, uncontrolled cardiac arrhythmia e.g. atrial fibrillation/flutter, cerebrovascular accidents =6 months before first dose of study drug; c) any severe or uncontrolled other disease or condition which might increase the risk associated with study participation; d) known active Hepatitis B e.g. hepatitis B surface antigen reactive, or Hepatitis C e.g. hepatitis C virus RNA (qualitative) is detected. 7. Known history of Human Immunodeficiency Virus (HIV) i.e. presence of HIV 1/2 antibodies. 8. Diagnosis of immunodeficiency or requirement for systemic steroid therapy or any other form of immunosuppressive therapy <7 days prior to the first dose study drug. Topical steroid creams for symptomatic relief for patients in Cohort C (TMF) are exceptions to this rule. Also, the use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor/Medical Monitor. 9. Any other malignancy known to be active, with the exception of treated cervical intra-epithelial neoplasia and non-melanoma skin cancer. 10. General intolerance of any protocol medication or its excipients. 11. Patient´s inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly. 12. Patient is unwilling to comply with the protocol; including the required biopsies and PK sampling. 13. Prior treatment with AFM13.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antitumor activity of AFM13 by Independent Review Committee confirmed objective response rate (ORR);Primary end point(s): To assess the antitumor activity of AFM13 by an Independent Review Committee (IRC)-confirmed objective response rate (ORR); Secondary Objective: •To assess the antitumor activity of AFM13 by Investigator-assessed ORR (defined as ORR-2) • To assess the duration of response (DOR) to AFM13 • To assess the safety and tolerability of AFM13 • To assess the serum pharmacokinetics (PK) of AFM13 • To assess the immunogenicity of AFM13 • To assess Quality of Life (QOL) of patients while on treatment with AFM13 ;Timepoint(s) of evaluation of this end point: ORR (CR + PR) as confirmed by an IRC as assessed by the modified Lugano Classification (Cheson, 2014) for Cohorts A and B (PTCL) and after at least 8 weeks from the first assessment as assessed by Olsen Criteria (Olsen, 2011) for Cohort C (TMF)(see Appendix F of protocol) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) To assess the antitumor activity of AFM13 by: o IRC-confirmed CR and PR rates and PET-CT-based ORR o Investigator-assessed ORR (defined as ORR-2) 2)To assess the duration of response (DOR) to AFM13 3) To assess the safety and tolerability of AFM13 4) To assess the pharmacokinetics (PK) of AFM13 5) To assess the immunogenicity of AFM13 6) To assess Quality of Life (QOL) of patients while on treatment with AFM13 ; Timepoint(s) of evaluation of this end point: 1) At Screening and every 8 weeks for the first 3 assessments, then every 12 weeks thereafter. 2) Every 8 weeks for the first 3 assessments, then every 12 weeks thereafter. 3) Predose and at the end of each infusion (EOI), and laboratory safety evaluations. Cytokine levels in blood samples will be tested predose and EOI on Cycle 1 Day 1. 4) Evaluation of the levels of AFM13 in serum will be performed at the time points according to protocol. 5) Predose at Cycle 1 onwards on Days 1 and 29, for assessment of anti-drug antibodies against AFM13. 6) At the screening phase and then again at the beginning of treatment cycle 2 and 3 and at then at the final study visit. | — |
Countries
Australia, France, Germany, Italy, Korea, Republic of, Poland, Russian Federation, Spain, Turkey, United States
Contacts
Public ContactMichael Karl
ICON Clinical Research GmbH
Outcome results
None listed