Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL

Stopped early · Phase 2

Conditions studied: Relapsed or Refractory Hodgkin Lymphoma, Peripheral T Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT05883449

Run by

Affimed GmbH

People needed

25

Starts

2023-10-10

Expected to finish

2025-06-13

Last updated by the study team

2025-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• O'Neal Comprehensive Cancer Center at UAB — Birmingham, Alabama, United States
• City of Hope National Medical Center — Duarte, California, United States
• UC Irvine Health — Orange, California, United States
• Sarah Cannon Research Institute — Denver, Colorado, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Beth Israel Deaconess Medical — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• John Theurer Cancer Center — Hackensack, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• UNC Immunotherapy Team, University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pennsylvania, Abramson Cancer Center — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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