18 and older, any sex, with Peripheral T Cell Lymphoma or Transformed Mycosis Fungoides. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate Assessed by Independent Review Committee Based on PET-CTPrimary· Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).
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).
Group
Value
95% CI
Cohort A
32.4
23.7 – 42.1
Overall Response Rate Assessed by Investigator Based on PET-CTSecondary· Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
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).
Group
Value
95% CI
Cohort A
32.4
23.7 – 42.1
Overall Response Rate Assessed by Investigator Based on CTSecondary· Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
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).
Group
Value
95% CI
Cohort A
30.6
22.1 – 40.2
Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CTSecondary· Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
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).
Complete response rate (CR rate)
Group
Value
95% CI
Cohort A
12.0
6.6 – 19.7
Partial response rate (PR rate)
Group
Value
95% CI
Cohort A
20.4
13.2 – 29.2
Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CTSecondary· Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
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).
Overall response rate (ORR)
Group
Value
95% CI
Cohort A
25.0
17.2 – 34.3
Complete response rate (CR rate)
Group
Value
95% CI
Cohort A
7.4
3.3 – 14.1
Partial response rate (PR rate)
Group
Value
95% CI
Cohort A
17.6
10.9 – 26.1
Duration of Overall Response Assessed by Independent Review Committee Based on PET-CTSecondary· Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
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).
Group
Value
95% CI
Cohort A
2.3
1.9 – 8.7
Duration of Overall Response Assessed by Independent Review Committee Based on CTSecondary· Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
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).
Group
Value
95% CI
Cohort A
5.3
1.9 – 6.9
Duration of Overall Response Assessed by Investigator Based on PET-CTSecondary· Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
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.
Group
Value
95% CI
Cohort A
3.3
1.9 – 8.7
Duration of Overall Response Assessed by Investigator Based on CTSecondary· Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
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.
Group
Value
95% CI
Cohort A
6.3
2.0 – 8.7
Number of Subjects With Treatment Related Adverse EventSecondary· From the date of first treatment until the date of the last treatment + 37 days, up to 199 weeks.
Number of subjects who had treatment (AFM13) related Adverse Events.
Group
Value
95% CI
Cohort A
105
Maximum Measured Concentration (Cmax) of AFM13Secondary· 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.
Maximum measured concentration (Cmax) of the AFM13 in serum. Geometric coefficient of variation is given in percentages.
Cycle 1 - day 1
Group
Value
95% CI
Cohort A
26232
± 270
Cycle 1 - day 29
Group
Value
95% CI
Cohort A
24435
± 364
Area Under the Concentration-Time Curve of AFM13 From 0 to Infinity (AUC 0-∞)Secondary· 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 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.
Cycle 1 - day 1
Group
Value
95% CI
Cohort A
612361
± 60.3
Cycle 1 - day 29
Group
Value
95% CI
Cohort A
749717
± 35
Adverse events — posted to ClinicalTrials.gov
Time frame: From the date of first treatment till the date of the last treatment + 37 days, up to 199 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort A
Serious: 44/108 (41%)
Deaths: 52/108
Serious adverse events (44 terms)
Reaction
System
Cohort A
COVID-19
Infections and infestations
—
Pneumonia
Infections and infestations
—
Infusion related reaction
Injury, poisoning and procedural complications
—
Acute kidney injury
Renal and urinary disorders
—
Herpes zoster
Infections and infestations
—
Septic shock
Infections and infestations
—
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
—
Pyrexia
General disorders
—
Diffuse large B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Other Affimed GmbH trials
Trials by the same sponsor.
NCT05883449 — Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL
· Phase 2
· terminated
NCT05817058 — First-in-Human Dose Escalation Study of AFM28 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
· Phase 1
· terminated
NCT05109442 — Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers
· Phase 1, PHASE2
· terminated
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· Phase 1, PHASE2
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Affimed GmbH
Last refreshed: 5 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04101331.