Actively Recruiting
To Evaluate Safety and Efficacy of Autologous CD19 Chimeric Antigen Receptor (CAR)-T Cells in Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL)
Led by National University of Malaysia · Updated on 2024-11-21
20
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
N
National University of Malaysia
Lead Sponsor
P
Plutonet Sdn Bhd
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Phase II Open-Label Single-arm Study to Evaluate Safety and Efficacy of locally manufactured autologous CD19-directed CAR T-cells in Patients with Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL) or patients not eligible for hematopoietic stem cell transplantation (HCT)
CONDITIONS
Official Title
To Evaluate Safety and Efficacy of Autologous CD19 Chimeric Antigen Receptor (CAR)-T Cells in Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed CD19 positive B-cell Non-Hodgkin Lymphoma according to WHO classification
- Patients refractory to second-line treatment or relapsed after first-line treatment without curative options like hematopoietic stem cell transplantation, or relapse within one year of autologous HSCT
- At least one measurable lesion per revised IWG response criteria
- Age between 13 and 75 years
- Adequate organ function: creatinine clearance >40 ml/min, ALT <5 times normal, bilirubin <3 times normal, left ventricular ejection fraction >45%
- Absolute neutrophil count ≥1500/µl, hemoglobin ≥7 g/dl, platelets ≥50000/µl
- Life expectancy greater than 12 weeks
- ECOG performance status ≤2
- Females of childbearing age must have a negative pregnancy test and use two effective contraception methods
- Male patients must use two effective contraception methods
You will not qualify if you...
- Active central nervous system lymphoma detected by imaging or cerebrospinal fluid analysis
- Active cancers other than Non-Hodgkin Lymphoma or receiving cancer treatment
- Severe lung, heart (NYHA class III/IV, arrhythmia, heart block, uncontrolled hypertension), liver, or renal failure, or severe neurological disorder
- Active autoimmune disease requiring immunosuppressive therapy
- HIV positivity
- Active Hepatitis B or C infection
- Uncontrolled infection
- Pregnant or nursing females
- Receiving autologous or allogeneic stem cell transplant within 12 weeks of enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Universiti Kebangsaan Malaysia
Bandar Tun Razak, Kuala Lumpur, Malaysia
Actively Recruiting
Research Team
S
S Fadilah Abdul Wahid Dr.
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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