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NCT06121297 (CABA-201 in Systemic Lupus Erythematosus): BVCT ex-ante prediction vs. reported outcome

On 30 Nov 2023, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 14 Jun 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (despite moderate toxicity).

Clinical Trial

NCTID
NCT06121297
Acronym
RESET-SLE
Drug Name
CABA-201
Drug MoA
anti-CD19 CAR T
Drug Modality
cell therapy
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Systemic Lupus Erythematosus (SLE)
Human Patients
12
Sponsor
Cabaletta Bio
Phase
Phase 1 Phase 2

Prediction of , index 1359

Prospective Prediction
Prediction Index
1359
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient clinical benefit despite moderate toxicity)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
197 days in advance
Readout Data Interpretation
CABA201 reduced SLEDAI-2K score from 26 at baseline to 10 at week 4 of follow-up; an LN patient experienced dose-limiting Grade 4 ICANS.
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (despite moderate toxicity)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 1/2, Open-label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Systemic Lupus Erythematosus
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
28
Lead sponsor
Cabaletta Bio
Conditions
Systemic Lupus Erythematosus; Lupus Nephritis
Interventions
BIOLOGICAL: CABA-201; BIOLOGICAL: CABA-201
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2024-02-16
Primary completion
2029-12
Completion
2029-12
Primary outcomes
  • To evaluate incidence of adverse events (Up to 28 days after CABA-201 infusion)

NCT06121297 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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