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

NCT ID: NCT04101331

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-13
• Study Completion Date: 2024-01-11

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A

Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).

Group Type: EXPERIMENTAL

AFM13

Intervention Type: DRUG

weekly intravenous infusions of 200mg

Interventions

AFM13

weekly intravenous infusions of 200mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed CD30-positive PTCL (most subtypes allowed) or TMF per the revised World Health Organization 2016 classification (Swerdlow, 2016) by central assessment.
• Cohorts A and B (PTCL cohorts): measurable by the modified Lugano Classification (Cheson, 2014); measurable disease of ≥1.5 cm diameter by computed tomography (CT), assessed locally for eligibility. Note: fluorodeoxyglucose (FDG) avid disease by positron emission tomography (PET) recommended, if possible.
• Cohort C (TMF cohort): measurable by the Olsen Criteria (Olsen, 2011) including at least 1 cutaneous lymphoma lesion ≥2 cm in diameter, assessed locally for eligibility.
• Patients must have relapsed or refractory disease AND the following:
• Cohorts A and B (PTCL): patients must have received at least 1 prior line of systemic therapy. For patients with systemic ALCL, patients must have failed or be intolerant to brentuximab vedotin [BV]; Adcetris®
• Cohort C (TMF): patients must have received at least 1 prior line of systemic therapy; and have exhausted systemic therapies with regular approval for their disease

Exclusion Criteria

• Patients with the following subtypes of lymphoma: T-cell prolymphocytic leukemia; T-cell large granular lymphocytic leukemia; Chronic lymphoproliferative disorder of NK cells; Aggressive NK-cell leukemia; Extranodal NK-/T-cell lymphoma; Indolent T-cell lymphoproliferative disorder of the GI tract:
• Has had an allogenic tissue hematopoietic cell/solid organ transplant within the last 3 years. Note: Patients who have had a transplant >3 years ago are eligible as long as there are no signs/symptoms of graft versus host disease (GvHD).
• Requirement for systemic immunosuppressive therapy, e.g. GvHD therapy, <12 weeks prior to the first dose of study drug.
• Prior treatment with AFM13

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affimed GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karenza Alexis, MD

Role: STUDY_DIRECTOR

Affimed Inc.

Won Seog Kim, Dr

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Steven Horwitz, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)

Birmingham, Alabama, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

University of California Los Angeles (UCLA) Health

Los Angeles, California, United States

Emory University Clinic/Winship Cancer Institute

Atlanta, Georgia, United States

Ochsner Clinic Foundation/Precision Cancer Therapies Program

New Orleans, Louisiana, United States

University of Michigan Health | Rogel Cancer Center

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Center for Lymphoid Malignancies

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Washington Seattle Cancer Care Alliance

Seattle, Washington, United States

Royal Adelaide Hospital

Adelaide, , Australia

Flinders Medical Centre

Bedford Park, , Australia

Monash Health-Monash Medical Centre

Clayton, , Australia

Concord Repatriation General Hospital

Concord, , Australia

Gosford Hospital

Gosford, , Australia

Linear Clinical Research

Nedlands, , Australia

Centre Hospitalier Universitaire (CHU) de Bordeaux

Bordeaux, , France

Centre Hospitalier Universitaire de Brest

Brest, , France

CHD Vendée

La Roche-sur-Yon, , France

CHU Pontchaillou

Rennes, , France

Institut Gustave Roussy

Villejuif, , France

Kliniken Essen Sued - Evangelisches Krankenhaus Essen-Werden gGmbH

Essen, , Germany

University Hospital Leipzig

Leipzig, , Germany

Universitaetsmedizin Mainz

Mainz, , Germany

Rotkreuzklinikum Muenchen

München, , Germany

Ist.Ematologia E Oncologia Medica L.E A.Seragnoli

Bologna, , Italy

Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

Brescia, , Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

Meldola, , Italy

Azienda Ospedaliera Niguarda Ca' Granda

Milan, , Italy

Azienda Unita Sanitaria Locale di Ravenna - Ospedale S. Maria delle Croci di Ravenna

Ravenna, , Italy

Szpitale Pomorskie Sp. z o.o.. Szpital Morski im. PCK, Oddzial Hematologii i Transplantologii Szpiku

Gdynia, , Poland

Pratia MCM Krakow

Krakow, , Poland

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

Warsaw, , Poland

Instytut Hematologii i Transfuzjologii, Klinika Hematologii

Warsaw, , Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu. Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

Wroclaw, , Poland

Republic Hospital n.a. V.A. Baranov

Petrozavodsk, , Russia

First State Saint-Petersburg Pavlov Medical University

Saint Petersburg, , Russia

GUZ Leningrad Regional Clinical Hospital

Saint Petersburg, , Russia

Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency

Saint Petersburg, , Russia

Saratov State Medical University

Saratov, , Russia

Regional Clinical Hospital

Tula, , Russia

Chonbuk National University Hospital

Jeonju, , South Korea

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Duran I Reynals Hospital Catalan Institute Of Oncology

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol

Barcelona, , Spain

Institut Catala d' Oncologia Girona

Girona, , Spain

Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias

Madrid, , Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Institut Catala d'Oncologia Tarragona

Tarragona, , Spain

Ankara University Faculty of Medicine, Department of Internal Diseases, Hematology Division

Ankara, , Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim Arastirma Hastanesi Hematoloji Klinigi Ankara

Ankara, , Turkey (Türkiye)

Gazi University Faculty of Medicine, Department of Internal Diseases

Ankara, , Turkey (Türkiye)

Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırm Hastanesi

Ankara, , Turkey (Türkiye)

Istanbul Universitesi Istanbul Tip Fakultesi Ic Hastaliklari Anabilim Dali Hematoloji Bilim Dali Fatih

Istanbul, , Turkey (Türkiye)

Ege University Medical Faculty

Izmir, , Turkey (Türkiye)

Kocaeli University Faculty of Medicine, Department of Internal Diseases, Hematology Division

İzmit, , Turkey (Türkiye)

Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uyg. ve Egitim Merkezi

Samsun, , Turkey (Türkiye)

Tekirdag Namik Kemal Universitesi Saglik Uygulama ve Arastirma Hastanesi

Tekirdağ, , Turkey (Türkiye)

KaradenizTeknik Universitesi Tip Fakultesi Farabi Hastanesi

Trabzon, , Turkey (Türkiye)

Countries

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

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AFM13-202

Identifier Type: -

Identifier Source: org_study_id