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NCT05336409 (CNTY-101 IL-2 Lymphodepleting Chemotherapy in CD19-Positive B-Cell Malignancies): BVCT ex-ante prediction vs. reported outcome

On 14 Apr 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 3 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

Acronym
ELiPSE-1
Drug Name
CNTY-101 IL-2 Lymphodepleting Chemotherapy
Drug MoA
allogeneic anti-CD19 CAR-iNK cells with Allo-Evasion edits; IL-15 support; and EGFR safety switch
Drug Modality
CAR-NK cell therapy
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
CD19-Positive B-Cell Malignancies
Human Patients
75
Sponsor
Century Therapeutics
Phase
Phase 1

Prediction of , index 1546

Prospective Prediction
Prediction Index
1546
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit inferior to anti-CD19 CAR-T cell therapies)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
50 days in advance
Readout Data Interpretation
40-60% ORR (vs 74.1% ORR Anti-CD19 CAR-T cell therapy HR001).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
The ELiPSE-1 Study: A Phase 1, Multicenter, Open-Label Study of CNTY-101 in Subjects With Relapsed or Refractory CD19-Positive B-Cell Malignancies
Phase
Phase 1
Status
Terminated
Enrollment
28
Lead sponsor
Century Therapeutics, Inc.
Conditions
R/R CD19-Positive B-Cell Malignancies; Indolent Non-Hodgkin Lymphoma; Aggressive Non-Hodgkin Lymphoma
Interventions
BIOLOGICAL: CNTY-101; BIOLOGICAL: IL-2; DRUG: Lymphodepleting Chemotherapy
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2023-01-24
Primary completion
2025-07-01
Completion
2025-07-01
Primary outcomes
  • Maximum Tolerated Dose (MTD) as Determined by the Percentage of Participants With Dose Limiting Toxicities (DLTs) and DLTs Based on Severity (Up to 28 days)
  • Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC) (Up to 28 days)

NCT05336409 on ClinicalTrials.gov

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