Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AFM13 · 4 trials · 3 indications
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).
Measure occurrence of adverse events and monitor laboratory safety parameters. Immunogenicity of AFM13.
| Arm | Type | Description |
|---|---|---|
| Arm A | ACTIVE_COMPARATOR | AFM13 is administered three times a week (e.g. monday-wednesday-friday) for 8 consecutive weeks. Arm A ist closed. |
| Arm B | ACTIVE_COMPARATOR | AFM13 is administered three times a week (e.g. monday-wednesday-friday) for 2 consecutive weeks followed by a weekly appication 6 consecutive weeks. Arm B is closed. |
| Arm C | ACTIVE_COMPARATOR | AFM13 is administered for five consecutive days a week as continuous infusion for 8 consecutive weeks |
| Cohort A | EXPERIMENTAL | Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL). |
| AFM13 + Pembrolizumab | EXPERIMENTAL | Participants receive AFM13 in escalating doses intravenously (IV) for up to 25 weeks, pembrolizumab as a fixed dose intravenously (IV) for up to 52 weeks. |
| AFM13 | EXPERIMENTAL | IV (intravenous) infusion, dose escalation |
| Name | Type | Description |
|---|---|---|
| AFM13 | DRUG | - |
| Pembrolizumab | BIOLOGICAL | - |
| AFM 13 | DRUG | Cohort escalation then expansion phase design. Starting dose 0.01 mg/kg. 4 weekly drug administrations. |
Inclusion Criteria: * Patients with diagnosis of classical HL reconfirmed by histopathology and relapsed or refractory disease after standard therapy including brentuximab vedotin and anti-PD1 or PD-L1 antibodies * Age: 18 years or older (both genders) * ECOG performance status ≤2 * Life expectancy...
AFM13 is an investigational monoclonal antibody being studied for the treatment of Hodgkin Lymphoma and Peripheral T Cell Lymphoma. It is being developed by Affimed N.V. for use in oncology. The drug has received Fast Track designation from the FDA.
AFM13 is a monoclonal antibody that targets CD30, a protein expressed on certain lymphoma cells. By binding to CD30, AFM13 is designed to direct the immune system to attack and destroy these malignant cells. This mechanism is being evaluated in clinical trials for CD30-positive lymphomas.
AFM13 is being developed by Affimed N.V., a biopharmaceutical company. Affimed is focused on engineering targeted immunotherapies for cancer. The company's work on AFM13 includes clinical trials in Hodgkin Lymphoma and Peripheral T Cell Lymphoma.
AFM13 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and has not been approved by the FDA. The completed trials include studies in Hodgkin Lymphoma and Peripheral T Cell Lymphoma, with a total enrollment of 108 patients across all studies.
AFM13 has been studied in three completed clinical trials. NCT01221571 was a Phase 1 study in Hodgkin Lymphoma. NCT02321592 was a Phase 2 trial in relapsed or refractory Hodgkin Lymphoma. NCT02665650 was a Phase 1 combination study with pembrolizumab in classical Hodgkin Lymphoma. NCT04101331 was a Phase 2 study in CD30-positive T-cell lymphoma.
AFM13 is the primary name for this investigational drug. It is also referred to by its developmental code, AFM13, in clinical trial registrations. No other alternative names have been associated with this drug in the available clinical trial information.