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 therapy being studied for Hodgkin lymphoma and peripheral T cell lymphoma, including transformed mycosis fungoides. It is a CD30-directed monoclonal antibody developed for patients with relapsed or refractory disease. AFM13 has not been approved for commercial use and remains in clinical development.
AFM13 targets CD30, a receptor expressed on the surface of Hodgkin lymphoma and certain T cell lymphoma cells. By binding CD30, AFM13 is designed to direct the immune system toward CD30-positive tumor cells. Its clinical program has focused on CD30-positive lymphomas, and trials have used biomarker selection for CD30 expression.
AFM13 is being developed by Affimed N.V., a clinical-stage biopharmaceutical company that trades on the Nasdaq under the ticker symbol AFMD. Affimed has sponsored the clinical trials evaluating AFM13 in Hodgkin lymphoma and peripheral T cell lymphoma, including studies combining AFM13 with pembrolizumab.
AFM13 is in clinical development, with trials conducted across Phase 1 and Phase 2. It is investigational and has not been approved by the FDA. The FDA has granted AFM13 a Fast Track designation, which is intended to expedite review of drugs addressing serious conditions with unmet medical need.
AFM13 has been evaluated in completed studies including NCT04101331 in relapsed or refractory CD30-positive T cell lymphoma or transformed mycosis fungoides, NCT02665650 combining AFM13 with pembrolizumab in Hodgkin lymphoma, NCT02321592 in relapsed or refractory Hodgkin lymphoma, and NCT01221571 in Hodgkin lymphoma. These trials enrolled a total of 189 participants.
Yes, AFM13 and AFM 13 refer to the same investigational monoclonal antibody developed by Affimed N.V. The spacing difference is only a formatting variation used in some references. Both names describe the CD30-targeted therapy studied in Hodgkin lymphoma and peripheral T cell lymphoma.