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NCT04503278 (BTN211-01 in Advanced solid tumors): BVCT ex-ante prediction vs. reported outcome

On 9 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 17 Sep 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically maybe significant (against placebo) and commercially TBD.

Clinical Trial

NCTID
NCT04503278
Drug Name
BTN211-01
Drug MoA
anti-CLDN6 CAR-T cell and CLDN6 mRNA vaccine
Drug Modality
CAR-T
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced solid tumors
Human Patients
145
Sponsor
BioNTech
Phase
Phase 1

Prediction of , index 1734

Prospective Prediction
Prediction Index
1734
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS as monotherapy or in combination with CLDN6 mRNA vaccine)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in ORR/PFS as monotherapy or in combination with CLDN6 mRNA vaccine)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
39 days in advance
Readout Data Interpretation
BTN211-01 with/without CARVac achieved 5% real ORR (not counting tumor marker responses; there were 3/64 patients who achieved PR or CR) in testicular/ovarian cancer; very low efficacy.
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically maybe significant (against placebo) and commercially TBD
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of CLDN6 CAR-T With or Without CLDN6 RNA-LPX in Patients With CLDN6-positive Relapsed or Refractory Advanced Solid Tumors
Phase
Phase 1
Status
Active not recruiting
Enrollment
214
Lead sponsor
BioNTech Cell & Gene Therapies GmbH
Conditions
Solid Tumor
Interventions
BIOLOGICAL: CLDN6 CAR-T; BIOLOGICAL: CLDN6 uRNA-LPX/CLDN6 modRNA-LPX
Design
Non randomized · Factorial · None
Primary purpose
Treatment
Start
2020-09-16
Primary completion
2028-08
Completion
2041-08
Primary outcomes
  • Occurrence of treatment-emergent adverse events (TEAEs) including ≥ Grade 3, serious, fatal TEAEs by relationship (up to 25 months)
  • Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAEs (up to 25 months)
  • Occurrence of dose-limiting toxicity (DLT) during the DLT evaluation period (Day 1 to day 28)

NCT04503278 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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