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Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides

NCT04101331 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2024-11-05

Study results available
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Summary

This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A) recombinant antibody construct which is being developed to treat CD30-positive malignancies.

Patients who suffer from peripheral T-cell lymphoma or transformed mycosis fungoides, whose tumor expresses the surface marker CD30, and who have relapsed after an earlier treatment or have refractory disease will be enrolled into this study if all of the study entry criteria are fulfilled. Dependent on their disease type and the magnitude of CD30 expression, study participants will be assigned to one of 3 study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion).

The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of overall responses. Further goals are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the potential formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood.

Approx. 1 month after the last dose of AFM13 there will be a final study visit to assess the patients' health status after therapy, followed by quarterly phone contacts to check on their overall health status and long-term survival.

Conditions

  • Peripheral T Cell Lymphoma
  • Transformed Mycosis Fungoides

Interventions

DRUG

AFM13

weekly intravenous infusions of 200mg

Sponsors & Collaborators

  • Affimed GmbH

    lead INDUSTRY

Principal Investigators

  • Karenza Alexis, MD · Affimed Inc.

  • Won Seog Kim, Dr · Samsung Medical Center

  • Steven Horwitz, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-13
Primary Completion
2022-05-11
Completion
2024-01-11
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Italy
  • Poland
  • Russia
  • South Korea
  • Spain
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04101331 on ClinicalTrials.gov