Trial · NCT07882641
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose limited toxicity (DLT) (phase 1) | Within 28 days post-infusion | DLT is defined as any of the following adverse events (AEs) related to BEX101 injection infusion occurring within 28 days after BEX101 injection infusion (CRS and ICANS will be graded according to the ASTCT 2019 criteria, and other AEs will be evaluated using CTCAE v6.0): * Grade ≥ 3 neurotoxicity and/or CRS that does not resolve to Grade ≤ 2 within 7 days after therapeutic intervention; * Grade ≥ 3 non-hematologic toxicities other than CRS and neurotoxicity that do not resolve to Grade ≤ 2 within 14 days despite appropriate clinical treatment and management, excluding clinically insignificant laboratory abnormalities; * Grade ≥ 4 hematologic toxicities, including decreased neutrophil count and decreased platelet count, persisting for \> 28 days after infusion of BEX101 injection. |
| Primary | Incidence and severity of AEs and serious AEs (SAEs) (phase 1) | Within 24 months post-infusion | AEs refer to any adverse medical events occurring in subjects from the initiation of BEX101 administration during clinical trials. SAEs denote events involving death, life-threatening conditions, significant disability/incapacity, hospitalization or prolonged hospitalization arising after BEX101 administration in subjects. |
| Primary | Incidence and severity of AEs of special interest (AESI) (phase 1) | Within 24 months post-infusion | AESI including grade ≥ 3 CRS, ICANS, and infections |
| Primary | Objective Response Rate (ORR) (phase 2) | Within 24 months post-infusion | ORR includes CR and PR. |
| Secondary | Incidence and severity of AEs (phase 2) | Within 24 months post-infusion | AEs refer to any adverse medical events occurring in subjects from the initiation of BEX101 administration during clinical trials. |
| Secondary | ORR (phase 1) | Within 24 months post-infusion | ORR includes CR and PR. |
| Secondary | Duration of Response (DOR) (phase 1 and phase 2) | Within 24 months post-infusion | Time from first documented PR or CR to relapse or disease progression, or death from any cause. |
| Secondary | Progression-Free Survival (PFS) (phase 1 and phase 2) | Within 24 months post-infusion | Time from administration to disease progression or death from any cause, which ever occurs first. |
| Secondary | Overall Survival (OS) (phase 1 and phase 2) | Within 24 months post-infusion | Time from administration to death from any cause. |
| Secondary | Number of CAR-positive T cells (phase 1 and phase 2) | Within 24 months post-infusion | Number of CAR-positive T cells in peripheral blood. |
| Secondary | CAR gene copy number (phase 1 and phase 2) | Within 24 months post-infusion | CAR gene copy number in peripheral blood. |
| Secondary | Number of CD19-positive cells (phase 1 and phase 2) | Within 24 months post-infusion | Number of CD19-positive cells in peripheral blood. |
| Secondary | Levels of cytokines (phase 1 and phase 2) | Within 24 months post-infusion | Levels of cytokines in peripheral blood. |
| Other | Infiltration of CAR-T cells (phase 1 and phase 2) | Within 3 months post-infusion | Infiltration of CAR-T cells in tumor tissue or bone marrow, or cerebrospinal fluid. |
| Other | Characteristics of the edited T cells and their in vivo evolutionary dynamics after infusion (phase 1 and phase 2) | Within 24 months post-infusion | Retain finished CAR-T product samples post-manufacturing, and perform phenotypic and multi-omics profiling on CAR-T cells at Day 0 (fresh finished product), peak expansion, and late time points following infusion. |
| Other | Correlation between subjects' baseline T-cell characteristics and CAR-T expansion and treatment response (phase 1 and phase 2) | Within 24 months post-infusion | To analyze the correlations between the immunophenotypic and omics characteristics of patients' baseline peripheral blood T cells and the peak expansion, persistence, and response of CAR-T cells after infusion. |
| Other | Changes in subjects' immune status from baseline to post-infusion (phase 1 and phase 2) | Within 24 months post-infusion | To analyze the patterns of change in innate and adaptive immune cells in patients' peripheral blood before and after infusion. |
| Other | Residual lentiviral levels (phase 1 and phase 2) | At 3 h and 24 h after CAR-T infusion. | To measure the level of residual lentivirus in peripheral blood collected from patients at 3 h and 24 h after CAR-T infusion. |
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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