Clinical Trials Logo
  1. Home
  2. Peripheral T-cell Lymphoma
  3. NCT04101331

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

Peripheral T Cell Lymphoma Clinical Trial

Official title:
A Phase II Open-label Multicenter Study to Assess the Efficacy and Safety of AFM13 in Patients With Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04101331
Study type Interventional
Source Affimed GmbH
Contact
Status Completed
Phase Phase 2
Start date November 13, 2019
Completion date January 11, 2024
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04526834 - Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma Phase 1
Recruiting NCT04390737 - Evaluate the Safety and Clinical Activity of HH2853 Phase 1/Phase 2
Recruiting NCT05559008 - A Umbrella Study in R/R PTCL Guided by Molecular Subtypes Phase 1/Phase 2
Recruiting NCT06083701 - Phase I/II Study of Linperlisib Plus Chidamide for R/R Peripheral T-cell Lymphoma: a Prospective, Multi-center Study Phase 1/Phase 2
Not yet recruiting NCT02856997 - Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma Phase 2
Recruiting NCT04083495 - CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma Phase 2
Not yet recruiting NCT05979792 - Clinical Study of CD7 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory CD7-positive Peripheral T Cell Lymphoma Early Phase 1
Recruiting NCT04984837 - Study of Lacutamab in Peripheral T-cell Lymphoma Phase 2
Recruiting NCT06072131 - To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL Phase 3
Completed NCT01716806 - A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL) Phase 2
Terminated NCT03947255 - A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma Phase 2
Recruiting NCT04028440 - γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) Early Phase 1
Not yet recruiting NCT05923502 - (CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)
Recruiting NCT05377827 - Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies Phase 1
Recruiting NCT05883449 - Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL Phase 2
Active, not recruiting NCT03586999 - Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas Phase 1/Phase 2
Recruiting NCT04489264 - The Role of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma
Recruiting NCT06151106 - Chidamide and Duvalisibon for the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma Phase 2
Recruiting NCT02753543 - Chidamide Plus Chemotherapy in the Treatment of Peripheral T-cell Lymphoma Phase 2
Not yet recruiting NCT06089941 - Circulating Tumor DNA Sequencing in Patients With Peripheral T-cell Lymphomas