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A Phase 2, Open-Label, Multi-Center Study of Innate Cell Engager AFM13 in Combination with Allogeneic Natural Killer Cells (AB-101) in Subjects with Recurrent or Refractory Hodgkin Lymphoma and CD-30 Positive Peripheral T-Cell Lymphoma


Description

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 subty

Trial Eligibility

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

Study Info

Organization

Affimed GmbH


Primary Outcome

Objective Response Rate by Independent Radiology Committee


Outcome Timeframe From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

NCTID NCT05883449

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2023-10-10

Completion Date 2026-04-30

Enrollment Target 154

Interventions

DRUG AFM13

DRUG AB-101

DRUG Cyclophosphamide

DRUG Fludarabine

DRUG Interleukin-2

Locations Recruiting

O'Neal Comprehensive Cancer Center at UAB

United States, Alabama, Birmingham


City of Hope National Medical Center

United States, California, Duarte


UC Irvine Health

United States, California, Orange


Sarah Cannon Research Institute

United States, Colorado, Denver


Norton Cancer Institute

United States, Kentucky, Louisville


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