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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 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG AFM13
Study Locations (20)
Other
- Royal Adelaide Hospital — Adelaide
- Flinders Medical Centre — Bedford Park
- Monash Health-Monash Medical Centre — Clayton
- Concord Repatriation General Hospital — Concord
- Gosford Hospital — Gosford
- Linear Clinical Research — Nedlands
- Centre Hospitalier Universitaire (CHU) de Bordeaux — Bordeaux
California
- City of Hope Comprehensive Cancer Center — Duarte
- University of California Los Angeles (UCLA) Health — Los Angeles
New York
- Center for Lymphoid Malignancies — New York
- Memorial Sloan Kettering Cancer Center — New York
Pennsylvania
- Abramson Cancer Center of the University of Pennsylvania — Philadelphia
- University of Pittsburgh Medical Center — Pittsburgh
Alabama
- University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center) — Birmingham
Georgia
- Emory University Clinic/Winship Cancer Institute — Atlanta
Louisiana
- Ochsner Clinic Foundation/Precision Cancer Therapies Program — New Orleans
Michigan
- University of Michigan Health | Rogel Cancer Center — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2019-11-13 |
| Est. Completion | 2024-01-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04101331
The ClinicalTrials.gov registry entry for NCT04101331 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Affimed, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Peripheral T Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention — of which AFM13 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04101331 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04101331 about?
NCT04101331 is a clinical study titled "Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides". 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 wh...
What is the current status of trial NCT04101331?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2019-11-13. Estimated completion is 2024-01-11.
What conditions does trial NCT04101331 study?
This clinical trial studies the following conditions: Peripheral T Cell Lymphoma, Transformed Mycosis Fungoides. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04101331?
The interventions under investigation include: AFM13 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04101331?
This trial is sponsored by Affimed, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04101331 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Louisiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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