Trial · NCT07897136
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From CAR-T cell infusion through 12 months after infusion. | Number of participants with at least one TEAE following CLL-1/CD70 CAR-T cell infusion, regardless of its relationship to treatment. TEAEs are adverse events that newly occur or worsen after infusion and include serious and non-serious events. Each participant will be counted once, irrespective of the number or type of TEAEs. Severity will be graded using NCI CTCAE v5.0, except that cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded using the ASTCT consensus criteria. Abnormal laboratory, vital sign, physical examination, and electrocardiogram findings will be included when they meet the protocol-defined adverse event criteria. |
| Secondary | Composite Complete Remission Rate (CRc) | At Months 1, 3, 6, 9, and 12 after CAR-T cell infusion. | Percentage of participants meeting the criteria for complete remission (CR), complete remission with partial hematologic recovery (CRh), or complete remission with incomplete hematologic recovery (CRi) at each prespecified assessment time point, according to the European LeukemiaNet (ELN) 2022 response criteria. |
| Secondary | Complete Remission (CR) Rate | At Months 1, 3, 6, 9, and 12 after CAR-T cell infusion. | Percentage of participants meeting the criteria for complete remission at each prespecified assessment time point. CR is defined as bone marrow blasts \<5%, absence of circulating blasts and extramedullary disease, an absolute neutrophil count ≥1.0 × 10\^9/L, and a platelet count ≥100 × 10\^9/L, according to the ELN 2022 response criteria. |
| Secondary | Complete Remission With Partial Hematologic Recovery (CRh) Rate | At Months 1, 3, 6, 9, and 12 after CAR-T cell infusion. | Percentage of participants meeting the criteria for CRh at each prespecified assessment time point. CRh is defined as meeting the morphologic criteria for CR, with an absolute neutrophil count ≥0.5 × 10\^9/L and a platelet count ≥50 × 10\^9/L, without meeting the criteria for CR, according to the ELN 2022 response criteria. |
| Secondary | Complete Remission With Incomplete Hematologic Recovery (CRi) Rate | At Months 1, 3, 6, 9, and 12 after CAR-T cell infusion. | Percentage of participants meeting the criteria for CRi at each prespecified assessment time point. CRi is defined as meeting the morphologic criteria for CR but with incomplete neutrophil or platelet recovery. Participants meeting the criteria for CR or CRh will not be included in this category. Response will be assessed according to the ELN 2022 criteria. |
| Secondary | No Response (NR) Rate | At Months 1, 3, 6, 9, and 12 after CAR-T cell infusion. | Percentage of response-evaluable participants who do not meet the criteria for CR, CRh, CRi, morphologic leukemia-free state (MLFS), or partial remission (PR) at each prespecified assessment time point. Response categories will be determined using the ELN 2022 criteria and the protocol-specified response assessment rules. |
| Secondary | Partial Remission (PR) Rate | At Months 1, 3, 6, 9, and 12 after CAR-T cell infusion. | Percentage of participants meeting the criteria for partial remission at each prespecified assessment time point. PR is defined as meeting all hematologic criteria for CR, with bone marrow blasts reduced to 5%-25% and a reduction of at least 50% from the pretreatment bone marrow blast percentage, according to the ELN 2022 response criteria. |
| Secondary | Morphologic Leukemia-Free State (MLFS) Rate | At Months 1, 3, 6, 9, and 12 after CAR-T cell infusion. | Percentage of participants meeting the criteria for MLFS at each prespecified assessment time point. MLFS is defined as bone marrow blasts \<5%, absence of circulating blasts and extramedullary disease, without requiring hematologic recovery. Bone marrow adequacy and response classification will be assessed according to the ELN 2022 criteria. |
| Secondary | Overall Survival (OS) | From CAR-T cell infusion through 12 months after infusion. | Time from CAR-T cell infusion to death from any cause, reported in months. Participants who have not died will be censored on the date they were last known to be alive. |
| Secondary | Event-Free Survival (EFS) | From CAR-T cell infusion through 12 months after infusion. | Time from CAR-T cell infusion to the first occurrence of a protocol-defined event: failure to achieve CR, CRh, or CRi at the protocol-specified response assessment; hematologic relapse after CR, CRh, or CRi; initiation of new anti-leukemia therapy; or death from any cause, whichever occurs first. Participants without an event will be censored on the date of their last adequate disease assessment. Time will be reported in months. |
| Secondary | Duration of Response (DOR) | From the first documented response through 12 months after CAR-T cell infusion. | Time from the first documented response to disease progression, relapse, or death from any cause, whichever occurs first, among participants achieving CR, CRh, CRi, MLFS, or PR. Duration will be reported in months. Censoring will follow the protocol-specified analysis rules. |
| Secondary | Cumulative Incidence of Relapse (CIR) | From the first documented remission through 12 months after CAR-T cell infusion. | Cumulative probability of hematologic relapse among participants achieving CR, CRh, or CRi, measured from the first documented achievement of remission. Death without prior relapse will be treated as a competing event. The cumulative incidence will be expressed as a percentage. |
| Secondary | Peripheral Blood CAR Transgene Copy Number | From CAR-T cell infusion through 12 months after infusion. | CAR transgene copy number in peripheral blood measured by quantitative polymerase chain reaction (qPCR) at each protocol-specified post-infusion sampling time point. Results will be reported as CAR transgene copies per microgram of genomic DNA (copies/µg genomic DNA). |
| Secondary | Maximum Observed Peripheral Blood CAR Transgene Copy Number (Cmax) | From CAR-T cell infusion through Day 28. | Maximum observed CAR transgene copy number in peripheral blood during the first 28 days after CAR-T cell infusion, determined from serial qPCR measurements. Cmax will be reported in copies/µg genomic DNA. |
| Secondary | Time to Maximum Observed Peripheral Blood CAR Transgene Copy Number (Tmax) | From CAR-T cell infusion through Day 28. | Elapsed time from CAR-T cell infusion to the maximum observed peripheral blood CAR transgene copy number during the first 28 days after infusion, determined from serial qPCR measurements. Tmax will be reported in days. |
| Secondary | Area Under the Peripheral Blood CAR Transgene Copy Number-Time Curve From Day 0 to Day 28 (AUC0-28d) | From CAR-T cell infusion through Day 28. | Area under the peripheral blood CAR transgene copy number-time curve from Day 0 to Day 28 after CAR-T cell infusion, calculated using the linear trapezoidal method. Results will be reported in copies·days/µg genomic DNA. Handling of the time-zero value and missing measurements will follow prespecified analysis rules. |
| Secondary | Measurable Residual Disease (MRD) Negativity Rate (Exploratory) | At Day 28 and Months 2, 3, 6, 9, and 12 after CAR-T cell infusion. | Percentage of participants with MRD-negative bone marrow at each prespecified post-infusion assessment time point among participants achieving CR, CRh, or CRi. MRD will be assessed by multiparameter flow cytometry with a target analytical sensitivity of 10\^-4. MRD negativity is defined as fewer than 0.01% leukemia-associated or different-from-normal immunophenotypic cells among CD45-expressing cells. Samples must meet assay quality requirements and include at least 500,000 assessed CD45-expressing cells to be evaluable for MRD negativity. Inadequate samples will not be classified as MRD-negative. |
| Secondary | Absolute Peripheral Blood CD3+ T-Cell Count | At screening, Day -1, Day 28, and Months 2, 3, 6, 9, and 12 after CAR-T cell infusion. | Absolute CD3+ T-cell count in peripheral blood measured by flow cytometry at each prespecified assessment time point. Results will be reported in cells/µL. |
| Secondary | Absolute Peripheral Blood CD4+ T-Cell Count | At screening, Day -1, Day 28, and Months 2, 3, 6, 9, and 12 after CAR-T cell infusion. | Absolute CD4+ T-cell count in peripheral blood measured by flow cytometry at each prespecified assessment time point. Results will be reported in cells/µL. |
| Secondary | Absolute Peripheral Blood CD8+ T-Cell Count | At screening, Day -1, Day 28, and Months 2, 3, 6, 9, and 12 after CAR-T cell infusion. | Absolute CD8+ T-cell count in peripheral blood measured by flow cytometry at each prespecified assessment time point. Results will be reported in cells/µL. |
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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