Trial · NCT07896213
Metabolically Fit CD19 CAR T Cells With CD34 Selection Markers in Adults With CD19-Positive B-Cell Acute Lymphocytic Leukemia
NCT07896213, Phase 1, Not yet recruiting, Medical University of South Carolina
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Metabolically Fit CD19 CAR T Cells With CD34 Selection Markers in Adults With CD19-Positive B-Cell Acute Lymphocytic Leukemia. Trials, record NCT07896213. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07896213
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metabolically Fit CD19 CAR T Cells With CD34 Selection Markers in Adults With CD19-Positive B-Cell Acute Lymphocytic Leukemia
- NCT number
- NCT07896213
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 18 participants, estimated
- Lead sponsor
- Medical University of South Carolina
- Conditions
- CD19 Positive, B-ALL, B-cell Acute Lymphocytic Leukemia, Chimeric Antigen Receptor T-cell, CAR-T Cell Therapy, MRD Positive Leukemia
- Interventions
- Fludarabine, Cyclophosphamide, Levetiracetam, CD19 CAR-T cells
- First posted
- 2026-10-26
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07896213
GET https://conductscience.org/api/trials/v1/NCT07896213/registered