Last updated 4 days ago
CD19 CAR-T Cell Therapy in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: A Phase I/II Study
30 patients around the world
Available in Mexico
This Phase I/II, open-label, single-center, single-arm, dose-escalation study is designed to evaluate the safety and efficacy of MB-CART19.1 in adult patients with r/r B-cell ALL. The primary objective is to determine the safety and tolerability of MB-CART19.1 and to establish the recommended Phase II dose (RP2D). Secondary objectives include the overall response rate (ORR), complete remission rate (CR), overall survival (OS), event-free survival (EFS), and leukemia-free survival (LFS).
Adult patients (18 to 60 years of age) with r/r B-cell ALL who have received at least two prior lines of therapy will be enrolled. Consented patients will go through the following five sequential stages: screening, leukapheresis, pre-conditioning, treatment, and follow-up. A 3+3 dose-escalation design will be used, and all patients will receive a single infusion of MB-CART19.1 on Day 0, at a dose level assigned according to the disease burden at the time of pre-conditioning.
Hospital Universitario Dr. Jose E. Gonzalez
1Research sites
30Patients around the world
This study is for people with
Leukemia
Acute lymphoblastic leukemia
Requirements for the patient
To 60 Years
All Gender
Medical requirements
- 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.
- 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.Pregnant or breastfeeding women.Evidence of myelodysplasia in bone marrow aspirate before the start of treatment.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.Grade 1 or higher adverse events associated with SARS-CoV-2, with the exception of peripheral neuropathy.
Sites
Hospital Universitario Dr. José Eleuterio González
StudyCARLLA-B1
SponsorHospital Universitario Dr. Jose E. Gonzalez
Study typeInterventional
Conditions
Acute lymphoblastic leukemia
Requirements
To 60 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07890025
