Phase 2 Study of AFM13 and AB-101 for Treating Relapsed or Refractory Hodgkin Lymphoma and CD30+ Peripheral T-Cell Lymphoma

Sponsor: Affimed GmbH

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05883449

Provider View

This clinical trial is testing a new combination of drugs, AFM13 and AB-101, to see if they are safe and effective for patients with relapsed or refractory Hodgkin Lymphoma and CD30-positive Peripheral T-Cell Lymphoma.

Patient Parameters

Program Overview

The study is designed to evaluate the safety and effectiveness of combining two drugs, AFM13 and AB-101, in patients with relapsed or refractory classical Hodgkin Lymphoma (HL) and CD30-positive Peripheral T-Cell Lymphoma (PTCL). It begins with a safety phase to test different doses, followed by an expansion phase to further assess the treatment in more patients.

Description

The trial starts with a safety phase where different doses of AFM13 and AB-101 are tested in patients with classical Hodgkin Lymphoma. There are four groups, and the first two groups will start at the same time. The other two groups will only start if the treatment is well tolerated. After this phase, researchers will decide which two dose levels to continue testing in the main part of the study, which will also include patients with classical Hodgkin Lymphoma. This part of the study will follow a specific design to evaluate the treatment's effectiveness. Additionally, a separate group will explore the treatment in patients with certain types of CD30-positive Peripheral T-Cell Lymphoma after the safety phase is complete. All participants will receive the AFM13 and AB-101 treatment for up to three cycles, with each cycle lasting 48 days.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with relapsed or refractory classical Hodgkin Lymphoma or certain types of CD30-positive Peripheral T-Cell Lymphoma.
  • For PTCL patients, a tumor biopsy showing CD30 positivity is required.
  • Hodgkin Lymphoma patients must have had at least two previous treatments, including combination chemotherapy, brentuximab vedotin, and a PD1 inhibitor.
  • PTCL patients must have had at least one previous combination chemotherapy treatment. ALCL subtype patients must have tried or been intolerant to brentuximab vedotin.
  • Previous autologous stem cell transplant is allowed if done at least 3 months before the study. Allogeneic stem cell transplant is allowed if done at least 1 year before the study and there are no signs of graft vs. host disease.
  • Previous CAR-T therapy is allowed if completed at least 6 months before the study.
  • Must be able to understand and sign the informed consent form.

Exclusion Criteria

  • Active cancer in the brain or spinal fluid.
  • Previous treatment with AFM13 or CBNK cells.
  • History of organ transplant or autoimmune disease that could worsen with IL-2 treatment.
  • Recent treatment with certain antibodies or immunosuppressive drugs.
  • Active Hepatitis B or C infection.
  • Active HIV infection.
  • History of another cancer unless treated and disease-free for at least 2 years.
  • Active graft vs. host disease or significant central nervous system issues.

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