Trial · NCT07896213
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine the maximum tolerated dose (MTD) of CD19-CD34t metabolically programmed CAR-T cell therapy in adult patients with CD19-positive B-cell acute lymphocytic leukemia (B-ALL). | 28 days | The frequency and percentage of dose limiting toxicities (DLTs) summarized by dose level and overall. |
| Primary | Assess the safety of CD19-CD34t metabolically programmed CAR-T cell therapy | 28 days | The frequency and percentage of adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs) summarized by dose level and overall. |
| Primary | Determine the feasibility of manufacturing CD19-CD34t metabolically programmed CAR-T cell therapy within 15% of the target dose. | 28 days | Proportion of patients for whom their CAR-T cellular product is prepared within 15% of the target dose. Feasibility will be evaluated for initial and second infusion separately. |
| Secondary | Overall remission rate (ORR) | 28 days | Proportion of patients achieving a complete remission (CR) or a complete remission with incomplete recovery (CRi) for Cohort 1a. |
| Secondary | Rate of MRD-negative CR in bone marrow | 28 days | by NGS and/or flow cytometry in Cohort 1a, Cohort 1b, Retreatment cohort w/re-emergence of MRD) |
| Secondary | Stem cell transplantation prior to leukemia relapse | up to 5 years or a disease progression | Proportion of patients undergoing stem cell transplantation prior to leukemia relapse in Cohort 1a, Cohort 1b, Retreatment cohort w/relapse of CD19+ ALL |
| Secondary | Rate of B cell aplasia reinduction | up to 5 years or a disease progression | Reinduction of B cell aplasia retreatment cohort w/loss of B cell aplasia |
| Secondary | ORR after 2nd infusion | up to 5 years or disease progression | Proportion of patients achieving a complete remission (CR) or a complete remission with incomplete recovery (CRi) for Retreatment cohort w/relapse of CD19-positive ALL |
| Secondary | Rate of CR/CRi without stem cell transplantation or other subsequent therapy | up to 24 months | Proportion of patients in CR/CRi without stem cell transplant or other subsequent therapy at 6-, 12-, and 24-months following CAR-T infusion for Cohort 1a, Cohort 1b, Cohort 1c |
| Secondary | Rate of CD19-negative relapse | up to 5 years or disease progression | Incidence of CD19 negative relapse for Cohort 1a, Cohort 1b, Cohort 1c |
| Secondary | Progression-free survival (PFS) | up to 5 years or disease progression, relapse, or death | the time interval from first CAR-T cell infusion to disease progression, relapse, or death due to any cause in Cohort 1a, Cohort 1b, Cohort 1c |
| Secondary | Duration of response (DOR) | up to 5 years or response to disease progression or death | the time interval from first documented response to disease progression or death due to any cause. DOR is defined only among patients who experience a response to the CAR-T cell therapy Cohort 1a, Cohort 1b, Cohort 1c |
| Secondary | Overall survival (OS) | up to 5 years or death | the time interval from first CAR-T cell infusion to death due to any cause in Cohort 1a, Cohort 1b, Cohort 1c |
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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