BioinvestGPT ApS · Research use only

NCT05020678 (NKX019 in relapsed/refractory B cell malignancies): BVCT ex-ante prediction vs. reported outcome

On 15 Feb 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 7 Nov 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably insignificant and commercially probably insufficient.

Clinical Trial

Drug Name
NKX019
Drug MoA
allogeneic anti-CD19 CAR-NK cell therapy
Drug Modality
cell therapy
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
relapsed/refractory B cell malignancies
Human Patients
150
Sponsor
Nkarta
Phase
Phase 1

Prediction of , index 1471

Prospective Prediction
Prediction Index
1471
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit inferior to anti-CD19 CAR-T cell therapies)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
266 days in advance
Readout Data Interpretation
NKX019's further development has been forgone based on data review
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably insignificant and commercially probably insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With B-cell Malignancies
Phase
Phase 1
Status
Active not recruiting
Enrollment
150
Lead sponsor
Nkarta, Inc.
Conditions
Lymphoma, Non-Hodgkin; B-cell Acute Lymphoblastic Leukemia; Large B-cell Lymphoma; Mantle Cell Lymphoma; Indolent Lymphoma; Waldenstrom Macroglobulinemia; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Aggressive Lymphoma; Large-cell Lymphoma
Interventions
BIOLOGICAL: NKX019
Design
Single group · None
Primary purpose
Treatment
Start
2021-08-20
Primary completion
2025-03-31
Completion
2038-12
Primary outcomes
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (30 days after last dose of NKX019)
  • Proportion of subjects experiencing dose-limiting toxicities of NKX019 (28 days from first dose of NKX019)
  • Objective response rate to NKX019 in Part 2 (Primary assessment: 28 days after the first dose of NKX019 followed up to 2 years after the last dose of NKX019])

NCT05020678 on ClinicalTrials.gov

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