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

Launched by AFFIMED GMBH · May 30, 2023

Keywords

ClinConnect Summary

This clinical trial, called AFM13-203, is studying a new treatment combining two drugs, AFM13 and AB-101, for patients with relapsed or refractory Hodgkin lymphoma (HL) and certain types of peripheral T-cell lymphoma (PTCL). The trial aims to see how safe and effective this combination is for people whose cancer has not responded to previous treatments. The study is currently recruiting participants aged 65 and older who have specific types of these lymphomas and meet certain health criteria.

To be eligible, participants must have had prior treatments, including specific therapies like brentuximab vedotin and a PD-1 inhibitor for HL, or at least one line of chemotherapy for PTCL. Before joining, patients will need to provide a biopsy of their tumor to confirm the presence of a specific marker (CD30). During the trial, participants will receive the study treatment and will be closely monitored for any side effects and how well the drugs work. It's important to know that individuals with certain health issues, like active infections or serious autoimmune conditions, cannot participate in this study.

Gender

ALL

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