CAR-T cell therapy for adults with returned or resistant B-cell acute lymphoblastic leukemia
Tests MB-CART19.1 cell therapy in adults with relapsed or resistant leukemia.
Plain-language title generated from the registry record
Registry title: CD19 CAR-T Cell Therapy in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: A Phase I/II Study
Key facts
- Where
- Monterrey, MexicoSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07890025, who can take part
Where in Mexico
- Hospital Universitario Dr. Jose E. GonzalezMonterrey, MexicoNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Universitario Dr. Jose E. Gonzalez
- Trial code
- NCT07890025
- Record updated
- 22 October 2026
- Original description
This is a Phase I/II study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL).Read full original descriptionShow less
An Open-Label, Single-Center, Phase I/II Study Evaluating the Safety and Efficacy of a CAR T Cell Therapy Targeting CD19, in Adult Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
This is a Phase I/II study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL).
Inclusion: From 18 to 60 years old; Signed informed consent prior to participation in the study; Diagnosis of relapsed or refractory B-cell ALL after at least two lines of treatment; Documented CD19 positivity either by immunohistochemistry analysis or flow cytometry in the last available evaluation; ECOG performance status ≤2; Women of childbearing potential must have a negative serum pregnancy test; Adequate renal, hepatic, pulmonary, and cardiac function; Bone marrow function specifications at least 48 hours prior to recruitment: hemoglobin ≥8 g/dL, absolute neutrophil count (ANC) ≥500/µL, absolute lymphocyte count ≥300/µL, platelet count ≥30,000/µL.
Exclusion: Recipient of CAR-T cell therapy outside this protocol; Active involvement of the central nervous system or meninges by any neoplasm (patients with a history of CNS or meningeal involvement must be in documented remission by CSF evaluation for at least 90 days before registration); History of active malignant neoplasm other than the underlying B-cell ALL, excluding non-melanoma skin cancer; Active or ongoing infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, pulmonary abnormalities, or psychiatric illnesses/social situations that would limit compliance with the study requirements; Active infection by human immunodeficiency virus (HIV); Serologic status that reflects active infection by hepatitis B or C; History of COVID-19 infection in the last 3 months; Pregnant or breastfeeding women; Evidence of myelodysplasia in bone marrow aspirate before the start of treatment; Grade 1 or higher adverse events associated with SARS-CoV-2, with the exception of peripheral neuropathy.