Actively Recruiting
CD19 Chimeric Antigen Receptor (CAR) T Cells in Adults With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia
Led by King Faisal Specialist Hospital & Research Center · Updated on 2026-01-22
24
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
K
King Faisal Specialist Hospital & Research Center
Lead Sponsor
M
Miltenyi Biomedicine GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase Ia, open label, dose finding single center trial designed to evaluate the maximum tolerated dose, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of CD19 CAR T cells targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in adults (age 18 - 75) with relapsed/refractory acute lymphoblastic leukemia (ALL).
CONDITIONS
Official Title
CD19 Chimeric Antigen Receptor (CAR) T Cells in Adults With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 to 75 years old
- Signed informed consent form
- Ability to comply with the study protocol
- Relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) with specific conditions including second or greater bone marrow relapse, primary or chemo-refractory disease, Philadelphia chromosome-positive ALL with failed tyrosine kinase inhibitor therapy, or relapse after allogeneic stem cell transplant
- Bone marrow with at least 5% lymphoblasts by morphologic assessment at screening
- Documentation of CD19 tumor expression in bone marrow or peripheral blood within 1 month of study entry for relapsed patients
- Patients with prior central nervous system involvement must be in clinical remission
- Alanine aminotransferase (ALT) no more than 5 times the upper limit of normal
- Bilirubin no more than 2 times the upper limit of normal
- Good renal function with creatinine clearance of at least 60 cc/min
- Absolute neutrophil count (ANC) of at least 1.0 x 10^9/L without growth factors
- Platelet count of at least 50 x 10^9/L without transfusion support within 7 days
- Absolute lymphocyte count of at least 0.5 x 10^9/L
- Adequate organ function including renal, hepatic, pulmonary (oxygen saturation at least 93%), and cardiac function (left ventricular ejection fraction at least 45%)
- Grade 1 or less dyspnea and oxygen saturation over 93% on room air
- Karnofsky performance status of at least 70% and/or ECOG 0-2
- Women of childbearing age must have a negative pregnancy test within 7 days prior to enrollment
- Use of effective birth control for women from 1 month prior to screening until 12 months after infusion and condom use by males for 6 months after infusion
- Meet criteria for leukapheresis or have an acceptable stored leukapheresis product
You will not qualify if you...
- Active central nervous system involvement by malignancy
- Uncontrolled seizure disorder unrelated to ALL
- Significant cardiovascular problems such as recent stroke, transient ischemic attack, myocardial infarction, symptomatic heart failure, unstable angina, or arrhythmias requiring therapy
- Left ventricular ejection fraction less than 45%
- Creatinine clearance below 60
- Genetic bone marrow failure syndromes (except Down syndrome)
- Burkitt lymphoma/leukemia
- Prior malignancy except treated carcinoma in situ of skin or cervix with no active disease
- Prior gene therapy products except prior CAR T-cell therapy
- Positive HIV test within 8 weeks
- Active hepatitis B or C infection with positive PCR
- Received investigational drug within 30 days prior to screening
- Pregnant or lactating women
- Inadequate contraception use for women of childbearing potential and males
- Use of systemic steroids, TKIs, hydroxyurea, or certain chemotherapy drugs within specified washout periods prior to lymphodepletion
- Recent pegylated asparaginase use within 4 weeks prior to infusion
- Recent CNS or non-CNS radiation therapy within specified timeframes
- History of severe allergic reactions to study agents or related compounds
- Autologous transplant within 6 weeks prior to CAR T-cell infusion
- Evidence of myelodysplasia or cytogenetic abnormality indicating myelodysplasia
- Known primary immunodeficiency disorders
- Recent live vaccine administration within 4 weeks prior to enrollment or within 6 weeks prior to lymphodepleting chemotherapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
King Faisal Specialist Hospital and Research Center
Riyadh, Riyadh Region, Saudi Arabia
Actively Recruiting
Research Team
R
Riad El Fakih
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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