Actively Recruiting
MB-CART19.1 in Relapsed/Refractory Acute Lymphoblastic Leukemia
Led by King Hussein Cancer Center · Updated on 2026-03-25
12
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MB-CART19.1 in Relapsed/Refractory Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1 year or older, if deemed fit by the treating investigator
- Detection of CD19 expression of 20% or more on malignant cells by flow cytometry
- Relapsed or refractory disease with more than 5% blasts in bone marrow after at least one frontline and one salvage chemotherapy regimen
- For Philadelphia-positive disease, use of a second generation or higher tyrosine kinase inhibitor in treatment
- Patients who relapsed after allogeneic stem cell transplant at least 100 days prior, with no active graft versus host disease and no immunosuppressive drugs for at least 30 days before enrollment
- Estimated life expectancy greater than 12 weeks
- Karnofsky or Lansky performance score of 60 or higher
- Written informed consent or assent provided by patients and/or parents
- Central nervous system and/or testicular involvement allowed if cleared and systemic involvement present
You will not qualify if you...
- Rapidly progressive or uncontrolled disease as assessed by physician
- Persistent extramedullary disease
- Isolated central nervous system and/or testicular disease
- Current autoimmune disease or history of autoimmune disease with possible CNS involvement
- Active hepatitis B, hepatitis C, or HIV infection
- Active significant central nervous system dysfunction, including uncontrolled seizures, cerebrovascular events, dementia, or paralysis
- History of another malignancy within the past 3 years, except non-melanoma skin cancer or carcinoma in situ
- Severe lung disease with FEV1 or FVC less than 65%, oxygen requirement above 28% FiO2, or active lung infection
- Left ventricular ejection fraction below 50% by echocardiography
- Creatinine clearance below 50 mL/min/1.73 m2
- Liver function with serum bilirubin 3 times or more above upper limit or AST or ALT more than 5 times above upper limit unless due to leukemic liver infiltration
- Pregnant or breastfeeding females
- Use of systemic chemotherapy, corticosteroids above physiologic replacement dose, tyrosine kinase inhibitors within 7 days before leukapheresis, fludarabine, clofarabine, immunosuppressive drugs, antibodies, investigational drugs, or donor lymphocyte infusion
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Trial Site Locations
Total: 1 location
1
King Hussein Cancer Center
Amman, Jordan, 11941
Actively Recruiting
Research Team
D
Dr. Zaid Abdel Rahman, Consultant,Hematology/Oncology
CONTACT
D
Dr. Hasan Hashem, Consultant,Hematology/Oncology
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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