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NCT05817058 (AFM28 in Relapsed/​Refractory Acute Myeloid Leukemia): BVCT ex-ante prediction vs. reported outcome

On 29 Feb 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 9 Dec 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically maybe significant and commercially insufficient.

Clinical Trial

NCTID
NCT05817058
Drug Name
AFM28
Drug MoA
CD123 x CD16A tetravalent NK cell engager
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Relapsed/​Refractory Acute Myeloid Leukemia
Human Patients
30
Sponsor
Affimed
Phase
Phase 1

Prediction of , index 1490

Prospective Prediction
Prediction Index
1490
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in ORR/CR)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
284 days in advance
Readout Data Interpretation
AFM28 achieved 31% CR/CRi (5/16 for 250mg and 300mg); inferior to SoC that achieved 69% CR/CRi (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically maybe significant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official 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 CD123-Positive Relapsed/Refractory Acute Myeloid Leukemia
Phase
Phase 1
Status
Terminated
Enrollment
30
Lead sponsor
Affimed GmbH
Conditions
Acute Myeloid Leukemia
Interventions
DRUG: AFM28
Design
Single group · None
Primary purpose
Treatment
Start
2023-03-21
Primary completion
2024-11-28
Completion
2025-06-13
Primary outcomes
  • The Incidence of dose limiting toxicities (28 days following the first dose of study treatment)

NCT05817058 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials