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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFM13 | Drug | weekly intravenous infusions of 200mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate Assessed by Independent Review Committee Based on PET-CT | Overall response by Positron Emission Tomography-Computed Tomography (PET-CT) as defined by achieving complete response and/or partial response assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014). | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate Assessed by Investigator Based on PET-CT | Overall response by Positron Emission Tomography-Computed Tomography (PET-CT) as defined by achieving complete response and/or partial response assessed by the investigator utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014). | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karenza Alexis, MD | Affimed Inc. | Study Director |
| Won Seog Kim, Dr | Samsung Medical Center | Principal Investigator |
| Steven Horwitz, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center) | Birmingham | Alabama | 35294 | United States | ||
All the subjects were screened for CD30 expression. Investigators assessed the subjects, and they were enrolled in the study if they met all inclusion criteria and none of the exclusion criteria.
This study was a Phase II open-label multicenter study to assess the efficacy and safety of AFM13 in subjects with relapsed or refractory CD30-positive peripheral T-cell lymphoma.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A | Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 31, 2023 | Sep 27, 2024 |
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| Overall Response Rate Assessed by Investigator Based on CT | Overall response by Computed Tomography (CT) as defined by achieving complete response and/or partial response assessed by the investigator utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014). | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). |
| Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT | Complete response and/or partial response by Positron Emission Tomography-Computed Tomography (PET-CT) assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014). | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). |
| Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT | Overall response by Computed Tomography (CT) as defined by achieving complete response and/or partial response assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014). | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). |
| Duration of Overall Response Assessed by Independent Review Committee Based on PET-CT | Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Positron Emission Tomography-Computed Tomography (PET-CT) by Independent Review Committee (IRC). | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). |
| Duration of Overall Response Assessed by Independent Review Committee Based on CT | Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Computed Tomography (CT) by Independent Review Committee (IRC). | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). |
| Duration of Overall Response Assessed by Investigator Based on PET-CT | Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Positron Emission Tomography-Computed Tomography (PET-CT) by the investigator. | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). |
| Duration of Overall Response Assessed by Investigator Based on CT | Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Computed Tomography (CT) by the investigator. | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). |
| Number of Subjects With Treatment Related Adverse Event | Number of subjects who had treatment (AFM13) related Adverse Events. | From the date of first treatment until the date of the last treatment + 37 days, up to 199 weeks. |
| Maximum Measured Concentration (Cmax) of AFM13 | Maximum measured concentration (Cmax) of the AFM13 in serum. Geometric coefficient of variation is given in percentages. | Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29. |
| Area Under the Concentration-Time Curve of AFM13 From 0 to Infinity (AUC 0-∞) | Area under concentration (AUC) versus time curve of the AFM13 in serum over time interval from 0 extrapolated to infinity. Geometric coefficient of variation is given in percentages. | Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29. |
| Volume of Distribution at Steady State (Vss) of AFM13 | Volume of distribution at steady state (Vss) of the AFM13. Geometric coefficient of variation is given in percentages. | Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 29. |
| The Terminal Half-life (t1/2) of AFM13 | The terminal half-life (t1/2) of the AFM13. Geometric coefficient of variation is given in percentages. | Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29. |
| European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D) | Quality of Life (QoL) as measured by the European QoL 5-dimensional questionnaire (EQ-5D) for Cohorts A. The EQ-5D comprises asks for the current health state in the five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Pain/discomfort scores assessed based on questionnaire. The categories of the response offer three levels pain/discomfort score: "no pain or discomfort" (score of 1), "moderate pain or discomfort" (score of 2), and "extreme pain and discomfort" (score of 3). Scores are presented from baseline to each visit for Cohort A. | At baseline and final study visit, up to 199 weeks. |
| European Quality of Life 5-dimensional Visual Analogue Scale Scores (EQ-5D) | Quality of Life (QoL) as measured by the European Quality of Life 5-dimensional questionnaire (EQ-5D) for Cohorts A. Visual Analogue Scale scores assessed based on drawn scale from 0(worst imaginable state) to 100(best imaginable state). Subjects chose their health state on scale based on their situation by themselves. A negative outcome indicates a decrease in score compared to the baseline value. | From baseline until final study visit, up to 199 weeks. |
| Number of Subjects Who Developed Anti-drug Antibodies (ADA) During Treatment | Number of subjects who had treatment (AFM13) and developed anti-drug antibodies (ADA). | Pre-dose Day 1 on cycle 1 and end of treatment, up to approximately 46 months. |
| City of Hope Comprehensive Cancer Center |
| Duarte |
| California |
| 91010 |
| United States |
| University of California Los Angeles (UCLA) Health | Los Angeles | California | 90404 | United States |
| Emory University Clinic/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Ochsner Clinic Foundation/Precision Cancer Therapies Program | New Orleans | Louisiana | 70121 | United States |
| University of Michigan Health | Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Center for Lymphoid Malignancies | New York | New York | 10019 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Washington Seattle Cancer Care Alliance | Seattle | Washington | 98109 | 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) |
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS): consist of all subjects who received at least one dose of AFM13.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A | Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate Assessed by Independent Review Committee Based on PET-CT | Overall response by Positron Emission Tomography-Computed Tomography (PET-CT) as defined by achieving complete response and/or partial response assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014). | The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13. | Posted | Number | 95% Confidence Interval | percentage | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months). |
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| Secondary | Overall Response Rate Assessed by Investigator Based on PET-CT | Overall response by Positron Emission Tomography-Computed Tomography (PET-CT) as defined by achieving complete response and/or partial response assessed by the investigator utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014). | The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13. | Posted | Number | 95% Confidence Interval | percentage | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). |
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| Secondary | Overall Response Rate Assessed by Investigator Based on CT | Overall response by Computed Tomography (CT) as defined by achieving complete response and/or partial response assessed by the investigator utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014). | The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13. | Posted | Number | 95% Confidence Interval | percentage | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). |
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| Secondary | Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT | Complete response and/or partial response by Positron Emission Tomography-Computed Tomography (PET-CT) assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014). | The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13. | Posted | Number | 95% Confidence Interval | percentage | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). |
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| Secondary | Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT | Overall response by Computed Tomography (CT) as defined by achieving complete response and/or partial response assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014). | The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13. | Posted | Number | 95% Confidence Interval | percentage | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). |
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| Secondary | Duration of Overall Response Assessed by Independent Review Committee Based on PET-CT | Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Positron Emission Tomography-Computed Tomography (PET-CT) by Independent Review Committee (IRC). | All subjects of the full analysis set (FAS) who had a response in PET assessed by IRC. | Posted | Median | 95% Confidence Interval | months | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). |
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| Secondary | Duration of Overall Response Assessed by Independent Review Committee Based on CT | Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Computed Tomography (CT) by Independent Review Committee (IRC). | All subjects of the full analysis set (FAS) who had a response in CT assessed by IRC. | Posted | Median | 95% Confidence Interval | months | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). |
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| Secondary | Duration of Overall Response Assessed by Investigator Based on PET-CT | Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Positron Emission Tomography-Computed Tomography (PET-CT) by the investigator. | All subjects of the full analysis set (FAS) who had a response in PET-CT assessed by investigator. | Posted | Median | 95% Confidence Interval | months | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). |
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| Secondary | Duration of Overall Response Assessed by Investigator Based on CT | Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Computed Tomography (CT) by the investigator. | All subjects of the full analysis set (FAS) who had a response in CT assessed by investigator. | Posted | Median | 95% Confidence Interval | months | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). |
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| Secondary | Number of Subjects With Treatment Related Adverse Event | Number of subjects who had treatment (AFM13) related Adverse Events. | The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment. | Posted | Count of Participants | Participants | From the date of first treatment until the date of the last treatment + 37 days, up to 199 weeks. |
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| Secondary | Maximum Measured Concentration (Cmax) of AFM13 | Maximum measured concentration (Cmax) of the AFM13 in serum. Geometric coefficient of variation is given in percentages. | The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram/milliliter | Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29. |
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| Secondary | Area Under the Concentration-Time Curve of AFM13 From 0 to Infinity (AUC 0-∞) | Area under concentration (AUC) versus time curve of the AFM13 in serum over time interval from 0 extrapolated to infinity. Geometric coefficient of variation is given in percentages. | The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/milliliter | Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29. |
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| Secondary | Volume of Distribution at Steady State (Vss) of AFM13 | Volume of distribution at steady state (Vss) of the AFM13. Geometric coefficient of variation is given in percentages. | The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 29. |
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| Secondary | The Terminal Half-life (t1/2) of AFM13 | The terminal half-life (t1/2) of the AFM13. Geometric coefficient of variation is given in percentages. | The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29. |
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| Secondary | European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D) | Quality of Life (QoL) as measured by the European QoL 5-dimensional questionnaire (EQ-5D) for Cohorts A. The EQ-5D comprises asks for the current health state in the five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Pain/discomfort scores assessed based on questionnaire. The categories of the response offer three levels pain/discomfort score: "no pain or discomfort" (score of 1), "moderate pain or discomfort" (score of 2), and "extreme pain and discomfort" (score of 3). Scores are presented from baseline to each visit for Cohort A. | The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13. | Posted | Count of Participants | Participants | At baseline and final study visit, up to 199 weeks. |
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| Secondary | European Quality of Life 5-dimensional Visual Analogue Scale Scores (EQ-5D) | Quality of Life (QoL) as measured by the European Quality of Life 5-dimensional questionnaire (EQ-5D) for Cohorts A. Visual Analogue Scale scores assessed based on drawn scale from 0(worst imaginable state) to 100(best imaginable state). Subjects chose their health state on scale based on their situation by themselves. A negative outcome indicates a decrease in score compared to the baseline value. | The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13. | Posted | Mean | Standard Deviation | score on a scale | From baseline until final study visit, up to 199 weeks. |
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| Secondary | Number of Subjects Who Developed Anti-drug Antibodies (ADA) During Treatment | Number of subjects who had treatment (AFM13) and developed anti-drug antibodies (ADA). | The safety set consisted of all subjects who received at least one dose of AFM13and had at least one post-baseline safety assessment. | Posted | Count of Participants | Participants | Pre-dose Day 1 on cycle 1 and end of treatment, up to approximately 46 months. |
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From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks.
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A | Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL). | 52 | 108 | 44 | 108 | 95 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Vascular access site infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Device Related Sepsis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
|
The sponsor has the right to review communications for 90 days prior to public release (whereby the sponsor may ask to consider modifications to ensure necessary protection of sponsor's IP). Any publication shall be not made before the first multi-centre publication if the study is a part of a multi-centred clinical trial. Also, if a publication concerns the analyses of data from a multi-centred clinical trial, the communication shall make reference to the relevant multi-centre publication
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Affimed GmbH | +49 621 560030 | trials@affimed.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2022 | May 8, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000723551 | AFM13 |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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