CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
AFM13drug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Age 18 years or older
  • ✓Histologically confirmed CD30-positive lymphoma with cutaneous involvement
  • ✓Failure or intolerance to at least one prior therapy for the current disease
  • ✓Presence of one or more cutaneous lesions measuring at least 1 cm × 1 cm
Key exclusion· 9
  • ✕Any cancer-related therapy for the current disease within 2 weeks of screening
  • ✕Major surgery within 2 weeks prior to first dose of study drug
  • ✕Evidence of active central nervous system (CNS) involvement
  • ✕Requirement for systemic immunosuppressive therapy (e.g., GVHD therapy) within 12 weeks before first dose

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03192202
NCT03192202Phase 2Completed
CompareCT.gov

Clinical and Biological Evaluation of the Novel CD30/CD16A Tetravalent Bispecific Antibody (AFM13) in Relapsed or Refractory CD30-Positive Lymphoma With Cutaneous Presentation: A Biomarker Phase Ib/IIa Study

Ahmed Sawas·interventional·Posted Jun 20, 2017·Updated Jul 20, 2023

In Brief

A Phase 2 clinical trial evaluating AFM13 for Lymphoma, T-Cell, Cutaneous. Completed, enrolled 18 participants across 1 site.

Detailed Summary

The investigators plan to investigate AFM13 and evaluate its ability to facilitate and redirect the Natural Killer (NK) cells in eliminating CD30-positive lymphoma targets in the skin and, by inference, other organs involved by the lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, T-Cell, Cutaneous
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 20, 2017
Enrollment StartJul 17, 2017
Primary CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.0 years ago

Interventions

AFM13drug

AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.