Trial · NCT05993299
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | Up to approximately 36 months | Modified intent-to-treat (mITT) population included all participants who received any dose of Lete-cel. | percentage of participants | NUMBER |
| SECONDARY | Time to Response (TTR) | Up to approximately 54 months | |||
| SECONDARY | Duration of Response (DOR) | Up to approximately 54 months | |||
| SECONDARY | Disease Control Rate (DCR) | Up to approximately 36 months | Modified intent-to-treat (mITT) population included all participants who received any dose of Lete-cel. | Percentage of Participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Up to approximately 54 months | |||
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Up to approximately 54 months | |||
| SECONDARY | Number of Participants With AEs of Special Interest (AESIs) | Up to approximately 54 months | |||
| SECONDARY | Number of Participants With TEAEs and TESAEs by Severity | Up to approximately 54 months | |||
| SECONDARY | Number of Participants With AESIs by Severity | Up to approximately 54 months | |||
| SECONDARY | Percentage of Participants With Replication Competent Lentivirus (RCL) Positive | Up to approximately 54 months | |||
| SECONDARY | Instances of Insertional Oncogenesis (IO) | Up to approximately 54 months | |||
| SECONDARY | Maximum Transgene Expansion (Cmax) | Day 1 to Day 14 | Pharmacokinetic (PK) population included participants in the safety population from whom at least one persistence sample was obtained, analyzed and was measurable. | Copies per microgram genomic DNA | GEOMETRIC_MEAN |
| SECONDARY | Time to Cmax (Tmax) | Day 1 to Day 14 | Pharmacokinetic (PK) population | Days | MEDIAN |
| SECONDARY | Area Under the Time Curve From Zero to Time 28 Days (AUC[0-28]) | Up to 28 days | Pharmacokinetic (PK) population | Days*copies per microgram genomic DNA | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05993299/outcomes