Approval Probability
TA Base Rate
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ML Risk
Also known as AFM 13
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 CD30-positive lymphomas, specifically relapsed or refractory Hodgkin lymphoma and peripheral T cell lymphoma, including transformed mycosis fungoides. It is not approved for any indication and remains in clinical development.
AFM13 is a bispecific monoclonal antibody that targets CD30 on lymphoma cells and CD16A on natural killer cells, bridging the two to enhance antibody-dependent cellular cytotoxicity. This mechanism is designed to direct immune effector cells to CD30-positive tumors.
AFM13 is being developed by Affimed N.V., a clinical-stage biopharmaceutical company. Affimed trades on the Nasdaq under the ticker symbol AFMD.
AFM13 is in Phase 2 clinical development. It has received Fast Track designation from the FDA but is not approved for any indication. All completed trials to date include Phase 1 and Phase 2 studies.
AFM13 has been evaluated in completed trials including NCT04101331 (Phase 2 in peripheral T cell lymphoma), NCT02665650 (Phase 1 with pembrolizumab in Hodgkin lymphoma), NCT02321592 (Phase 2 in Hodgkin lymphoma), and NCT01221571 (Phase 1 in Hodgkin lymphoma). No active trials are currently listed.
Yes, AFM13 and AFM 13 refer to the same investigational drug candidate developed by Affimed N.V. The spacing is a formatting variation of the same name.