Actively Recruiting
Study of CART Cell (MB-CART19.1) in Patients With Relapsed or Refractory CD19 Positive NHL
Led by King Hussein Cancer Center · Updated on 2025-12-09
26
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Prospective Single Center, open label, Non-randomized, Single Arm, Single Dose, Phase II Clinical Trial. Adult patients \>18-year-old with CD19+ Non-Hodgkin lymphoma are eligible for the study if they meet eligibility criteria. Patients will receive a fresh single dose of MB-CART-19.1 and will be followed for 12 months and evaluated for efficacy and safety.
CONDITIONS
Official Title
Study of CART Cell (MB-CART19.1) in Patients With Relapsed or Refractory CD19 Positive NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of aggressive Non-Hodgkin lymphoma after progression on at least one standard chemotherapy and one salvage regimen, or ineligible for allogeneic stem cell transplant, or relapsed at least 100 days post transplant without active graft-versus-host disease
- Patients with central nervous system disease are eligible only if it has been successfully cleared before enrollment
- Malignant cells must show CD19 expression confirmed by flow cytometry or immunohistochemistry
- Age between 18 and 75 years and deemed fit by the treating investigator
- Baseline absolute CD3+ T cell count of at least 100/µl
- Eastern Cooperative Oncology Group (ECOG) performance score between 0 and 2 at screening
- No active Hepatitis B, Hepatitis C, or HIV I/II infections
- Women with childbearing potential must have a negative pregnancy test within 7 days prior to lymphodepletion chemotherapy
- Signed and dated informed consent before any study-specific procedures
You will not qualify if you...
- Residual central nervous system disease
- Current or history of autoimmune disease involving the central nervous system
- Active significant central nervous system dysfunction such as uncontrolled seizures, stroke, dementia, or paralysis
- History of another malignancy except non-melanoma skin cancer or carcinoma in situ unless disease free for 3 or more years
- Severe lung disease or lung function with DLCO less than 50% or active pulmonary infiltrates
- Cardiac ejection fraction less than 50% by echocardiogram
- Renal function with creatinine clearance less than 50 mL/min/1.73 m2
- Liver function with serum bilirubin 3 times above normal or AST/ALT greater than 5 times normal unless due to lymphoma
- Rapidly progressive disease that may prevent completing study therapy
- Pregnant or breastfeeding females
- Use of systemic chemotherapy, corticosteroids beyond replacement dosing, immunosuppressive drugs, investigational drugs, or radiation therapy within specified time frames before apheresis
- Unwillingness to use effective birth control from enrollment through three months after dosing
- Participation in another interventional trial that could interfere with this study
- Other investigational treatment within 4 weeks prior to CAR T-cell infusion
- Cerebral dysfunction or legal incapacity
- Committal to an institution by judicial or official order
AI-Screening
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Trial Site Locations
Total: 1 location
1
King Hussein Cancer Center
Amman, Jordan, 11941
Actively Recruiting
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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