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NCT05883449 (AFM13 AB-101 Cyclophosphamide Fludarabine… in Relapsed or Refractory Hodgkin Lymphoma Peripheral…): BVCT ex-ante prediction vs. reported outcome

On 29 Feb 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 12 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05883449
Acronym
LuminICE-203
Drug Name
AFM13 AB-101 Cyclophosphamide Fludarabine Interleukin-2
Drug MoA
CD30 x CD16A tetravalent NK cell engager
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Relapsed or Refractory Hodgkin Lymphoma Peripheral T Cell Lymphoma
Human Patients
154
Sponsor
Affimed
Phase
Phase 2

Prediction of , index 1489

Prospective Prediction
Prediction Index
1489
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
104 days in advance
Readout Data Interpretation
87.5% ORR (lower than 100% ORR for AFMD alone).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant 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 2, Open-Label, Multi-Center Study of Innate Cell Engager AFM13 in Combination With Allogeneic Natural Killer Cells (AB-101) in Subjects With Recurrent or Refractory Hodgkin Lymphoma and CD-30 Positive Peripheral T-Cell Lymphoma
Phase
Phase 2
Status
Terminated
Enrollment
25
Lead sponsor
Affimed GmbH
Conditions
Relapsed or Refractory Hodgkin Lymphoma; Peripheral T Cell Lymphoma
Interventions
DRUG: AFM13; DRUG: AB-101; DRUG: Cyclophosphamide; DRUG: Fludarabine; DRUG: Interleukin-2
Design
Randomized · Sequential · None
Primary purpose
Treatment
Start
2023-10-10
Primary completion
2024-11-07
Completion
2025-06-13
Results first posted
2025-08-20
Primary outcomes
  • Objective Response Rate (ORR) by Independent Radiology Committee (Disease assessments were conducted on Day 43 (+- 3 days) of each cycle. All subjects were treated for a maximum of 3 cycles.)

NCT05883449 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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