Trial · NCT06743503
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with adverse events as assessed by CTCAE v5.0 | up to 24 months | Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities |
| Primary | Maximum tolerated dose (MTD) or maximum administered dose (MAD) of UB-VV400 alone and in combination with rapamycin. | up to 24 months | |
| Secondary | Objective response rate (ORR) per the Investigator using the Lugano 2014 criteria. | up to 24 months | |
| Other | Quantification of Immune cell subset frequencies (T/B/NK cells) | up to 24 months | |
| Other | Complete response (CR) rate, as determined by the Investigator using the Lugano 2014 criteria. | up to 24 months | |
| Other | Durability of response (DOR), the duration of response for subjects who acheived PR and CR as determined by the Investigator using the Lugano 2014 criteria. | up to 24 months | |
| Other | Progression-free survival (PFS) and Overall survival (OS). | up to 24 months | |
| Other | Quantification of plasma cytokines. | up to 24 months | |
| Other | Detection of integrated UB-VV400 transgene sequence and expression of CAR in peripheral blood. | up to 24 months | |
| Other | Maximum concentration (Cmax) of UB-VV400 particle and CAR-T cells. | up to 24 months | |
| Other | Time of maximum concentration (Tmax) of UB-VV400 particle and CAR-T cells. | up to 24 months | |
| Other | Area under the concentration versus time curve: UB-VV400 AUC0-7; CAR-T cell AUC0-28. | up to 24 months | |
| Other | Rate of incidence of anti-drug antibody, as determined by antibodies to UB-VV400 cocal glycoprotein (UB-VV400 pseudotyping) and anti-CD22 CAR (payload protein). | up to 24 months | |
| Other | Characterization of target antigen expression and biomarkers associated with immune cell infiltration and immunosuppression, as determined by CD22, CD4, CD8, FOXP3, CD56, CD3, CD20 expression. | up to 24 months | |
| Other | Analysis of correlation between CD22 expression frequency/levels and depth of response (PR or CR). | up to 24 months | |
| Other | Analysis of correlation between CD22 expression frequency/levels and the incidence rate and severity of AE. | up to 24 months |
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/NCT06743503/registered