Trial · NCT07890025
CD19 CAR-T Cell Therapy in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: A Phase I/II Study
NCT07890025, Phase 1, Phase 2, Not yet recruiting, Hospital Universitario Dr. Jose E. Gonzalez
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CD19 CAR-T Cell Therapy in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: A Phase I/II Study. Trials, record NCT07890025. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07890025
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CD19 CAR-T Cell Therapy in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: A Phase I/II Study
- NCT number
- NCT07890025
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Conditions
- Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
- Interventions
- MB-CART19.1
- First posted
- 2026-10-22
- Last updated
- 2026-10-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of dose-limiting toxicities (DLTs) and determination of the recommended Phase II dose (RP2D) | 30 days post-infusion | Safety and tolerability of MB-CART19.1 assessed by the incidence of dose-limiting toxicities (DLTs), defined as grade \>=3 adverse events considered related to MB-CART19.1 or the lymphodepletion regimen occurring within 30 days after infusion. The RP2D is defined as the maximum tolerated dose (MTD), or the highest dose level studied if the MTD is not reached, using a 3+3 dose-escalation design. |
| Primary | Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) | Up to 24 months post-infusion | Overall safety of MB-CART19.1 assessed by the frequency and severity of treatment-emergent AEs and SAEs. |
| Secondary | Overall response rate (ORR) | Day 30 and Day 100 post-infusion | Proportion of patients achieving an overall response, defined as complete remission (CR) plus complete remission with incomplete hematologic recovery (CRi), assessed by bone marrow morphology and flow cytometry. |
| Secondary | Complete remission rate with negative measurable residual disease (MRD) | Day 30 and Day 100 post-infusion | Proportion of patients achieving complete remission with negative MRD, defined as \<0.001% residual leukemic cells in bone marrow by multiparameter flow cytometry. |
| Secondary | Overall survival (OS) | Up to 24 months post-infusion | Time from study entry to death from any cause. |
| Secondary | Event-free survival (EFS) | Up to 24 months post-infusion | Time from MB-CART19.1 infusion to the first of the following events: absence of response, disease progression, relapse after achieving CR or CRi, or death from any cause. |
| Secondary | Leukemia-free survival (LFS) | Up to 24 months post-infusion | Time from documentation of complete remission to disease relapse or death related to the disease, whichever occurs first. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT07890025
GET https://conductscience.org/api/trials/v1/NCT07890025/registered