Trial · NCT07909434
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Dose-Limiting Toxicities (DLTs) | Day 1 through Day 28 after SY001 infusion | DLTs are defined as protocol-specified treatment-related hematologic or non-hematologic toxicities occurring during the 28-day DLT observation period. |
| Primary | Maximum Tolerated Dose (MTD) of SY001 | During the dose-escalation phase, based on DLTs occurring from Day 1 through Day 28 after infusion. | The MTD is defined as the highest dose level at which no more than 1 of 6 evaluable participants experiences a DLT. If the MTD is not reached at the highest planned dose level and no further dose escalation is pursued, the highest evaluated dose may be designated as the MTD according to the protocol. |
| Secondary | Objective Response Rate (ORR) | 6 months | ORR is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR), as assessed by investigators according to RECIST Version 1.1. |
| Secondary | Disease Control Rate (DCR) | 12 months | DCR is defined as the proportion of participants who achieve a best overall response of CR, PR, or stable disease (SD), as assessed according to RECIST Version 1.1. |
| Secondary | Duration of Response (DOR) | 12 months | DOR is defined as the time from the first documented CR or PR until the first documented disease progression or death from any cause, whichever occurs first. |
| Secondary | Progression-Free Survival (PFS) | 12 months | PFS is defined as the time from the first SY001 infusion to the first documented disease progression or death from any cause, whichever occurs first. |
| Secondary | Overall Survival (OS) | 24 months | OS is defined as the time from the first SY001 infusion to death from any cause. |
| Secondary | Maximum Observed CAR-Mix Copy Number in Peripheral Blood (Cmax) | 28 days | Cmax is defined as the maximum observed CAR-Mix copy number in peripheral blood following SY001 infusion, determined from serial blood samples collected at protocol-specified time points. |
| Secondary | Time to Maximum Observed CAR-Mix Copy Number in Peripheral Blood (Tmax) | 28 days | Tmax is defined as the elapsed time from SY001 infusion to the time at which the maximum CAR-Mix copy number is observed in peripheral blood. Tmax will be expressed in days. |
| Secondary | Area Under the CAR-Mix Copy Number-Time Curve From 0 to Tmax in Peripheral Blood (AUC 0-Tmax) | 28 days | AUC 0-Tmax is defined as the area under the CAR-Mix copy number-time curve in peripheral blood from the time of SY001 infusion to the time of maximum observed copy number (Tmax). |
| Secondary | Change from Baseline in IL-1β (pg/mL) Concentration | 28 days | The concentration of interleukin-1 beta (IL-1β) will be measured in peripheral blood serum and, when available, ascites supernatant using the protocol-specified cytokine assay. Changes from baseline will be evaluated following SY001 infusion. |
| Secondary | Change from Baseline in IL-2 (pg/mL) Concentration | 28 days | The concentration of interleukin-2 (IL-2) will be measured in peripheral blood serum and, when available, ascites supernatant using the protocol-specified cytokine assay. Changes from baseline will be evaluated following SY001 infusion. |
| Secondary | Change from Baseline in IL-6 (pg/mL) Concentration | 28 days | The concentration of interleukin-6 (IL-6) will be measured in peripheral blood serum and, when available, ascites supernatant using the protocol-specified cytokine assay. Changes from baseline will be evaluated following SY001 infusion. |
| Secondary | Change from Baseline in IL-10 (pg/mL) Concentration | 28 days | The concentration of interleukin-10 (IL-10) will be measured in peripheral blood serum and, when available, ascites supernatant using the protocol-specified cytokine assay. Changes from baseline will be evaluated following SY001 infusion. |
| Secondary | Change from Baseline in TNF-α (pg/mL) Concentration | 28 days | The concentration of tumor necrosis factor-alpha (TNF-α) will be measured in peripheral blood serum and, when available, ascites supernatant using the protocol-specified cytokine assay. Changes from baseline will be evaluated following SY001 infusion. |
| Secondary | Change from Baseline in IFN-γ (pg/mL) Concentration | 28 days | The concentration of interferon-gamma (IFN-γ) will be measured in peripheral blood serum and, when available, ascites supernatant using the protocol-specified cytokine assay. Changes from baseline will be evaluated following SY001 infusion. |
| Secondary | Incidence of Anti-SY001/CAR-Mix Antibodies | 12 months | Immunogenicity will be evaluated by assessing anti-CAR-Mix antibodies (anti-drug antibodies \[ADA\]) in peripheral blood and, when available, ascites. |
| Other | Changes in the Immune Microenvironment | 6 months | Changes in immune cell phenotypes and immune cell subsets in peripheral blood and, when available, ascites and tumor tissues will be explored using single-cell profiling and other protocol-specified immune analyses. |
| Other | Correlation Between Baseline Mesothelin Expression and Best Percentage Change in Target Lesion Size | 12 months | The Spearman rank correlation coefficient (rho) will be calculated to evaluate the correlation between baseline mesothelin (MSLN) expression and antitumor response. Baseline MSLN expression will be measured as the percentage of MSLN-positive tumor cells (%) using immunohistochemistry (IHC). Antitumor response will be measured as the best percentage change from baseline in the sum of target lesion diameters (%), assessed by CT according to RECIST Version 1.1 during the first 12 months following SY001 infusion. Only participants with evaluable baseline MSLN expression and post-baseline tumor measurements will be included. |
| Other | Tumor Infiltration of CAR-Mix Cells | 24 months | When tumor biopsy samples are available, infiltration of CAR-Mix cells into tumor tissue and associated changes in the tumor immune microenvironment will be explored. |
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.
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