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Combination treatment for relapsed Hodgkin lymphoma and peripheral T cell lymphoma

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 Interventional Affimed GmbH · NCT05883449

This study is testing a new combination treatment for people with relapsed Hodgkin lymphoma and certain types of peripheral T cell lymphoma to see if it is safe and effective.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment154 (estimated)
Ages18 Years and up
SexAll
SponsorAffimed GmbH Industry-sponsored
Drugs / interventionsbrentuximab, CAR-T, chemotherapy
Locations15 sites (Birmingham, Alabama and 14 other locations)
Trial IDNCT05883449 on ClinicalTrials.gov

What this trial studies

This phase 2 study evaluates the safety and efficacy of AFM13 in combination with AB-101 for patients with relapsed or refractory classical Hodgkin lymphoma (HL) and CD30-positive peripheral T cell lymphoma (PTCL). The study begins with a safety run-in phase to assess the treatment's tolerability, followed by expansion cohorts based on the results. Participants will receive the combination treatment for a maximum of three cycles, with a focus on specific patient cohorts based on their lymphoma subtype. The study aims to identify effective dose levels for further evaluation.

Who should consider this trial

Good fit: Ideal candidates include individuals with relapsed or refractory classical Hodgkin lymphoma or select subtypes of CD30-positive peripheral T cell lymphoma who have previously undergone specific lines of therapy.

Not a fit: Patients who have not been previously treated for their lymphoma or those with non-FDG-avid tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat relapsed or refractory lymphomas.

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating relapsed lymphomas, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed or Refractory Hodgkin LymphomaPeripheral T Cell Lymphoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.