Trial · NCT07903857
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities | From the start of lymphodepleting chemotherapy (Day -5) through Day 28 after SND002 Cell Injection infusion | Safety was assessed by treatment-emergent adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, serious adverse events, dose-limiting toxicities, clinical laboratory tests (hematology, serum chemistry, coagulation, urinalysis, cardiac enzymes, troponin, and thyroid function), 12-lead electrocardiogram, physical examination, and vital signs. |
| Primary | Recommended cell-dose range (cells) for further study as determined by the Safety Review Committee | Through completion of the dose-escalation part (Part A) | The recommended dose was defined as the cell-dose range selected for the expansion part on the basis of dose-limiting toxicities observed during dose escalation under a modified 3+3 design. |
| Primary | Percentage of participants with an objective response (complete response or partial response) assessed by RECIST 1.1 | From SND002 Cell Injection infusion through Week 24 | Objective response rate was defined as the proportion of participants whose best overall response was complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator. |
| Primary | Percentage of participants with disease control (complete response, partial response, or stable disease) assessed by RECIST 1.1 | From SND002 Cell Injection infusion through Week 24 | Disease control rate was defined as the proportion of participants whose best overall response was CR, PR, or stable disease (SD) according to RECIST 1.1. Stable disease was required to persist for at least 6 weeks. |
| Secondary | Progression-free survival (time from infusion to progression or death from any cause) assessed by the investigator according to RECIST 1.1 | From infusion until disease progression or death from any cause, whichever occurs first (up to 1 year) | |
| Secondary | Percentage of participants alive and progression-free at 1 year after infusion | At 1 year after infusion | |
| Secondary | Overall survival (time from infusion to death from any cause) | From infusion until death from any cause (up to 1 year) | |
| Secondary | Percentage of participants alive at 1 year after infusion | At 1 year after infusion | |
| Secondary | Time to response in participants with an objective response | From infusion to first documentation of CR or PR (up to 1 year) | |
| Secondary | Duration of response in participants with an objective response | From first documentation of CR or PR to first documentation of progression or death, whichever occurs first (up to 1 year) | |
| Secondary | Change from baseline in the percentage of SND002-specific T-cell receptor clones in peripheral blood | Before lymphodepleting chemotherapy (within 3 days) and on Day 7, Week 8, Week 24, Week 48, and Week 52 | Change from baseline in the percentage of SND002-specific T-cell receptor clones in peripheral blood. |
| Secondary | Change from baseline in peripheral blood immune cell subsets | Before lymphodepleting chemotherapy (within 3 days) and on Day 7, Week 8, Week 24, Week 48, and Week 52 | CD45+CD3+, CD3-CD19+, CD3-CD56+, CD3-CD14+, CD8+CD39-CD69-, CD4+CD39-CD69-, CD8+PD1+, CD4+PD1+, CD8+TIGIT+, and CD4+TIGIT+ |
| Secondary | Change from baseline in serum cytokine concentrations | Before lymphodepleting chemotherapy (within 3 days) and on Day 7, Week 8, Week 24, Week 48, and Week 52 | Including IFN-γ, TNF-α, IL-2, IL-6, GM-CSF, IL-4, IL-5, IL-8, IL-13, VEGF, MIP-1α, and IP-10 |
| Other | Change from baseline in circulating tumor cells and tumor markers | Before lymphodepleting chemotherapy (within 3 days) and on Day 7, Week 8, Week 24, Week 48, and Week 52 |
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.
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GET https://conductscience.org/api/trials/v1/NCT07903857/registered