Trial · NCT07891468
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 | Evaluate the safety of huCART19-IL18-CD428z cells | Up to 15 years post-infusion | Type, frequency, severity, and attribution of AEs/SAEs as assessed by CTCAE V6.0 |
| Primary | Evaluate the safety of huCART19-IL18-CD428z cells | 28 days post-huCART19-IL18-CD428z infusion | Occurrence of treatment-limiting toxicities (TLTs) |
| Secondary | Evaluate manufacturing feasibility | 2 months following enrollment | Occurrence of product release failures; occurrence of dose failures |
| Secondary | Overall Response Rate (ORR) - NHL/CLL/RT participants | Month 3 | Proportion of subjects with CR or PR at Month 3 as compared to baseline |
| Secondary | Overall Response Rate (ORR) - ALL participants | Day 28 | Proportion of subjects with CR/CRi/CRh/CRMRD- at Day 28 as compared to baseline. |
| Secondary | Best Overall Response (BOR) - NHL/CLL/RT participants | Month 3 - end of Primary Follow-Up | Proportion of subjects with a best overall response of CR or PR recorded between Month 3 and the end of Primary Follow-Up, as compared to baseline. |
| Secondary | Best Overall Response (BOR) - ALL participants | Day 28 - Month 6 | Proportion of subjects with a best overall response of CR/CRi/CRh/CRmrd- between Day 28 and Month 6, as compared to baseline. |
| Secondary | Duration of Response (DOR) - NHL/CLL/RT participants | Up to 15 years post-huCART19-IL18-CD428z infusion | Time from the date when the response criteria of CR/PR is first met (at or following Month 3), to the date of disease progression/relapse or death, whichever occurs first. |
| Secondary | Duration of Response (DOR) - ALL participants | Up to 15 years post-huCART19-IL18-CD428z infusion | Time from the date when the response criteria of CR/CRi/CRh/CRmrd- is first met (at or following Day 28), to the date of disease progression/relapse or death, whichever occurs first. |
| Secondary | Progression-free Survival (PFS) - NHL/CLL/RT participants | Up to 15 years post-huCART19-IL18-CD428z infusion | Duration of time from the huCART19-IL18-CD428z infusion to the date of confirmed disease progression or death, whichever occurs first. |
| Secondary | Event-free Survival (EFS) - ALL participants | Up to 15 years post-huCART19-IL18-CD428z infusion | Duration of time from the initial huCART19-IL18-CD428z infusion to the earliest date of disease progression/relapse, receipt of new anticancer therapy (including huCART19-IL18-CD428z retreatment and/or HSCT, even if in the setting of ongoing CR), or death |
| Secondary | Overall Survival (OS) | Up to 15 years post-huCART19-IL18-CD428z infusion | Duration of time from the first huCART19-IL18-CD428z infusion to the date of death |
| Secondary | Evaluate the effectiveness of huCART19-IL19-CD428z cells to delay or prevent viral rebound in the absence of antiretroviral therapy | Up to 2 years post-huCART19-IL18-CD428z infusion and in the setting of the analytical treatment interruption (ATI), if performed. | HIV viral rebound using Hologic's Aptima® HIV-1 Quant Dx Assay |
| Secondary | Evaluate the effectiveness of huCART19-IL19-CD428z cells to delay or prevent viral rebound in the absence of antiretroviral therapy | Up to 2 years post-huCART19-IL18-CD428z infusion and in the setting of the analytical treatment interruption (ATI), if performed. | Duration of Analytical Treatment Interruption (ATI) |
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/NCT07891468/registered