MB-CART19.1 cell therapy for relapsed or hard-to-treat acute lymphoblastic leukemia
Tests making MB-CART19.1 cells on site for children and adults with acute lymphoblastic leukemia.
Plain-language title generated from the registry record
Registry title: MB-CART19.1 in Relapsed/Refractory Acute Lymphoblastic Leukemia
Key facts
- Where
- Amman, JordanSee the site
Where in Jordan
- King Hussein Cancer CenterAmman, JordanTaking people
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
- King Hussein Cancer Center
- Trial code
- NCT07371403
- Record updated
- 5 August 2026
- Original description
Single-arm, prospective, open-label feasibility study evaluating the technical and operational feasibility of manufacturing autologous CD19-directed CAR-T cells (MB-CART19.1) at the point of care for the treatment of relapsed or refractory B-ALL in pediatric and adult patients.Read full original descriptionShow less
MB-CART19.1 in Patients With Relapsed/Refractory CD19-positive B Cell Acute Lymphoblastic Leukemia: A Feasibility Study
Single-arm, prospective, open-label feasibility study evaluating the technical and operational feasibility of manufacturing autologous CD19-directed CAR-T cells (MB-CART19.1) at the point of care for the treatment of relapsed or refractory B-ALL in pediatric and adult patients.
Inclusion: Age ≥ 1 year as long as if deemed fit by treating investigator; CD19 expression must be detected (≥20%) on the malignant cells by flow cytometry; Patients with relapsed or refractory disease with 0.01% or higher blasts in the bone marrow, or patients with confirmed disease progression as demonstrated by FDG PET-CT or CT/MRI of the affected lymph node or spleen after at least 2 cycles/lines of chemotherapy are eligible for enrollment. For patients with Philadelphia-positive disease, a second-generation or higher TKI must have been utilized in one of the treatment lines; Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active graft vs host disease, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment; Estimated life expectancy > 12 weeks; Karnofsky or Lansky (age dependent) performance score ≥ 60; Patients and/or parents must give their written informed consent/assent; CNS and/or testicular involvement are allowed, only if cleared and in the presence of systemic involvement.
Exclusion: Rapidly progressive, uncontrolled disease as assessed by the treating physician and/or principal investigator; Persistent extramedullary disease; Isolated CNS and/or testicular disease; Current autoimmune disease, or history of autoimmune disease with potential CNS involvement; Active hepatitis B, C or HIV; Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis); Pulmonary function: Patients with pre-existing severe lung disease (FEV1 or FVC < 65%) or an oxygen requirement of >28% O2 FiO2 or active pulmonary infection; Cardiac function: Left ventricular ejection fraction <50% by echocardiography; Renal function: Creatinine clearance <50 mL/min/1.73 m2; Liver function: patients with serum bilirubin ≥3 times upper limit of or AST or ALT > 5 times upper limit of normal, unless due to leukemic liver infiltration as determined by the investigators; Medications: systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing (<0.5 mg/kg/day of methylprednicone), tyrosine kinase inhibitors (TKI) within 7 days prior to leukapheresis, Fludarabine/clofarabine or immunosuppressive drugs and antibodies (e.g. rituximab, blinatumomab) or investigational drugs or donor lymphocyte; History of an additional malignancy (≤ 3 years) other than non-melanoma skin cancer or carcinoma in situ; Pregnant or breast-feeding females.