Phase 1 trial with AFM28 for patients with relapsed/refractory AML
Research type
Research Study
Full title
A Phase 1 Multicenter, Open Label, First-in-Human Dose Escalation Study of AFM28, a Bispecific ICE® that Targets CD123+ and CD16A, in patients with Relapsed/Refractory Acute Myeloid Leukemia
IRAS ID
1006906
Contact name
Sandra Schmid
Contact email
Sponsor organisation
Affimed GmbH
Eudract number
2022-002702-24
Clinicaltrials.gov Identifier
Research summary
Affimed GmbH is running a first-in-human Phase 1, open-label, non-randomised multiple ascending dose escalation study evaluating AFM28 as a monotherapy in participants with refractory or relapsed (R/R) CD123-positive acute myeloid leukaemia (AML) whose disease has progressed on or relapsed after treatment with previous anticancer therapies. AML is the most common acute leukaemia in adults, and is associated with a poor prognosis; only 10-15% elderly patients survive for >1 year from diagnoses. There is currently no standard-of-care AML treatment, due to poor tolerance of intensive therapies; there is an unmet need for effective R/R AML treatments. A protein called CD123 has been identified as a promising target for new therapies, due to it being highly expressed in leukaemic cancer cells, and its presence on healthy cells being limited. AFM28 is an antibody that specifically binds to the CD123 protein in leukaemic cells and activates signalling that causes cell death. AFM28 therefore aims to deplete the number of AML cancer cells. 50 participants diagnosed with CD123-positive AML are planned to take part in the study. Eligible participants will be assigned into groups, each of which will be given a varying intravenous dose of AFM28. The groups enrolled earlier in the study will receive lower doses of AFM28. If this low dose is found to be safe within the first 4 weeks of treatment, the next group of participants can receive the higher dose, and so on; this is a dose escalation study. The participants will receive AFM28 in treatment cycles, each of which will last 28 days. The number of cycles for each participant will differ, depending on if they are clinically benefitting from AFM28. Treatment will involve a minimum of 10 study visits, and will last a minimum of 9 weeks. Study assessments will include: vital signs, blood tests, ECGs, physical/neurological examination and bone marrow aspirates/biopsy.
Affimed GmbH is the sponsor and will organise/fund this study.REC name
London - Central Research Ethics Committee
REC reference
23/LO/0155
Date of REC Opinion
21 Mar 2023
REC opinion
Further Information Favourable Opinion