TERMINATED

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

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Conditions

Relapsed or Refractory Hodgkin LymphomaPeripheral T Cell Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-10-10
Study Completion:2025-06-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05883449

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects with a diagnosis of FDG-avid relapsed or refractory classical HL OR select subtypes of FDG-avid CD30-positive relapsed or refractory PTCL
  2. * 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)
  3. * 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.
  4. * 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.
  5. * 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.
  6. * Ability to understand and sign the ICF
  1. * Active central nervous system (CNS) involvement (untreated or uncontrolled parenchymal brain metastasis or positive cytology of cerebrospinal fluid)
  2. * Previous treatment with AFM13 or CBNK cells
  3. * 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
  4. * Treatment with any therapeutic mAb or immunosuppressive medications
  5. * Known active Hepatitis B or C defined per protocol
  6. * Active HIV Infection
  7. * History of any other systemic malignancy, unless previously treated with curative intent and the subject has been disease free for 2 years or longer
  8. * Active acute or chronic graft vs. host disease (GVHD) or GVHD requiring immunosuppressive treatment, clinically significant central nervous system (CNS) dysfunction

Contacts and Locations

Principal Investigator

Wunderle Lydia, MD
STUDY_DIRECTOR
Affimed Inc.

Study Locations (Sites)

O'Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama, 35294
United States
City of Hope National Medical Center
Duarte, California, 91010
United States
UC Irvine Health
Orange, California, 92868
United States
Sarah Cannon Research Institute
Denver, Colorado, 80218
United States
Norton Cancer Institute
Louisville, Kentucky, 40207
United States
Beth Israel Deaconess Medical
Boston, Massachusetts, 02215
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
John Theurer Cancer Center
Hackensack, New Jersey, 07601
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
UNC Immunotherapy Team, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States

Collaborators and Investigators

Sponsor: Affimed GmbH

  • Wunderle Lydia, MD, STUDY_DIRECTOR, Affimed Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-10
Study Completion Date2025-06-13

Study Record Updates

Study Start Date2023-10-10
Study Completion Date2025-06-13

Terms related to this study

Additional Relevant MeSH Terms

  • Relapsed or Refractory Hodgkin Lymphoma
  • Peripheral T Cell Lymphoma