phase 2 study of afm13 in combination with ab-101 in subjects with r/r hl and cd30+ ptcl

Conditions: Relapsed or Refractory Hodgkin Lymphoma; Peripheral T Cell Lymphoma

Summary: afm13-203 is a phase 2, open-label, multi-center, multi-cohort study with a safety run-in followed by expansion cohorts. the study is evaluating the safety and efficacy of afm13 in combination with ab-101 in subjects with r/r classical hl and cd30-positive ptcl.

the study will start with a safety run-in exploring afm13/ab-101 combination treatment in subjects with classical hl. two dose levels of afm13 and ab-101, respectively, will be tested in 4 cohorts. cohort 1 and 2 will enroll in parallel. enrolment into cohort 3 and 4 will start only if the combination treatment has been well tolerated. following the safety run-in observation period, a thorough risk-benefit analysis will be performed to determine 2 of the 4 cohorts/dose levels that will be further evaluated in the main part of the study which will also include subjects with classical hl and will follow a simon two-stage design. an additional exploratory cohort (cohort 5) will enroll subjects with select cd30-positive ptcl subtypes after completion of the safety run-in. all subjects will be treated with afm13/ab-101 for a maximum of 3 cycles (cycle length is 48-days).

Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of fdg-avid relapsed or refractory classical hl or select subtypes of fdg-avid cd30-positive relapsed or refractory ptcl * for subjects with r/r ptcl a pre-enrollment tumor biopsy positive for cd30 locally assessed by ber-h2 targeted immunohistochemistry at ≥1% is mandatory (ptcl subtypes: ptcl-nos, angioimmunoblastic t-cell lymphoma, alcl, anaplastic lymphoma kinase (alk)-positive, alcl, alk-negative) * subjects with r/r classical hl must have received at least two lines of therapy including one prior line of combination chemotherapy. prior therapy must also have included brentuximab vedotin and a pd1 check point inhibitor. * subjects with r/r ptcl must have received at least one prior line of combination chemotherapy. subjects with alcl subtype of ptcl must have received or been intolerant to brentuximab vedotin. * subjects with r/r classical hl and r/r ptcl: prior asct is permitted if completed at least 3 months prior to the first dose of study treatment. prior allogeneic stem cell transplantation will be permitted if completed at least 1 year from study enrollment and there are no signs or symptoms of gvhd. prior car-t therapy is permitted if last car-t dose completed at least 6 months prior to the first dose of study treatment. * ability to understand and sign the icf exclusion criteria: * active central nervous system (cns) involvement (untreated or uncontrolled parenchymal brain metastasis or positive cytology of cerebrospinal fluid) * previous treatment with afm13 or cbnk cells * history of a solid organ allograft, or an inflammatory or autoimmune disease likely to be exacerbated by il-2 (including subjects requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that may require systemic steroids or immunosuppressive agents * treatment with any therapeutic mab or immunosuppressive medications * known active hepatitis b or c defined per protocol * active hiv infection * history of any other systemic malignancy, unless previously treated with curative intent and the subject has been disease free for 2 years or longer * active acute or chronic graft vs. host disease (gvhd) or gvhd requiring immunosuppressive treatment, clinically significant central nervous system (cns) dysfunction