Trial · NCT07905261
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting toxicities (DLTs) | Dose-limiting toxicities (DLTs) will be assessed 28 days after the first dose. | |
| Primary | Occurrence of Adverse Events (AE) | Up to 24 months after administration of 6055 | |
| Primary | Occurrence of Serious Adverse Events (SAE) | Up to 24 months after administration of 6055 | |
| Primary | Recommended Phase 2 Dose (RP2D) of SYS6055 | through study completion, an average of 3 years | |
| Primary | Maximum Tolerated Dose (MTD) of SYS6055 | through study completion, an average of 3 years | |
| Secondary | Objective Response Rate (ORR) | through study completion, an average of 3 years | |
| Secondary | Time to Response（TTR ） | through study completion, an average of 3 years | |
| Secondary | Duration of Response (DoR) | through study completion, an average of 3 years | |
| Secondary | Progression-free survival (PFS) | through study completion, an average of 3 years | |
| Secondary | Overall Survival (OS) | through study completion, an average of 3 years | |
| Secondary | PK, CD19-CAR copy number and CD19 CAR-T cell content of SYS6055 | 2 years | The levels of CD19 CAR RNA and DNA in peripheral blood will be determined by qPCR, with the proportion of CD19 CAR-T cells assessed by flow cytometry. |
| Secondary | PK, CD19 CAR-T cell phenotypes | 2 years | CD19 CAR-T cell phenotypes will be analyzed by flow cytometry, including CD4/CD8 ratio, naïve cells, memory cells, and effector cells. |
| Secondary | PD | 2 years | Levels of cytokines in peripheral blood (IL-6, IL-10, IFN-γ, TNF-α, etc.). |
| Secondary | PD | 2 years | CRP |
| Secondary | PD | 2 years | ferritin levels |
| Secondary | PD | 2 years | immunoglobulin levels (IgG, IgA, IgM) |
| Secondary | PD | 2 years | peripheral blood lymphocyte subsets (proportion of T, B, and NK cells)，Lymphocyte subsets will be analyzed by flow cytometry. |
| Secondary | PD | 2 years | peripheral blood lymphocyte subsets (absolute counts of T, B, and NK cells). Lymphocyte subsets will be analyzed by flow cytometry. |
| Secondary | Immunogenicity | 2 years | Incidence of anti-CD19-CAR antibodies and antiviral antibodies. |
| Secondary | Viral shedding | 2 years | Peripheral blood, urine, saliva, and fecal samples will be collected at predefined time points for the assessment of viral shedding. |
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
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GET https://conductscience.org/api/trials/v1/NCT07905261/registered