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NCT05878184 (SC291 in r/r B-cell malignancies): BVCT ex-ante prediction vs. reported outcome

On 21 Oct 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 4 Nov 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably significant and commercially insufficient.

Clinical Trial

NCTID
NCT05878184
Acronym
ARDENT
Drug Name
SC291
Drug MoA
anti-CD19 CAR T cell therapy
Drug Modality
CAR-T therapy
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
r/r B-cell malignancies
Human Patients
16
Sponsor
Sana Biotechnology
Phase
Phase 1

Prediction of , index 1298

Prospective Prediction
Prediction Index
1298
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit due to inferior efficacy for NHL and non-superior efficacy for CLL compared with other anti-CD19 CAR T cell therapies)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
14 days in advance
Readout Data Interpretation
SC291 development discontinued without further disclosure of data
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably 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 Study Evaluating SC291, a Hypoimmune, Allogeneic CD19-directed CAR T Cell Therapy, in Relapsed and/or Refractory B-cell Malignancies (ARDENT)
Phase
Phase 1
Status
Active not recruiting
Enrollment
16
Lead sponsor
Sana Biotechnology
Conditions
Non Hodgkin Lymphoma; Chronic Lymphocytic Leukemia
Interventions
DRUG: SC291
Design
Single group · None
Primary purpose
Treatment
Start
2023-05-02
Primary completion
2025-11-04
Completion
2038-11-04
Primary outcomes
  • Evaluate safety and tolerability of SC291 (24 months)

NCT05878184 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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