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

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.

Conditions

Relapsed or Refractory Hodgkin Lymphoma, Peripheral T Cell Lymphoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Relapsed or Refractory Hodgkin Lymphoma
Intervention / Treatment

-

Contacts and Locations

Birmingham

O'Neal Comprehensive Cancer Center at UAB, Birmingham, Alabama, United States, 35294

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010

Orange

UC Irvine Health, Orange, California, United States, 92868

Denver

Sarah Cannon Research Institute, Denver, Colorado, United States, 80218

Louisville

Norton Cancer Institute, Louisville, Kentucky, United States, 40207

Boston

Beth Israel Deaconess Medical, Boston, Massachusetts, United States, 02215

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Minneapolis

Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States, 55455

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Hackensack

John Theurer Cancer Center, Hackensack, New Jersey, United States, 07601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Affimed GmbH,

Wunderle Lydia, MD, STUDY_DIRECTOR, Affimed Inc.

Study Record Dates

2027-11-30