To Evaluate Safety and Efficacy of Autologous CD19 Chimeric Antigen Receptor (CAR)-T Cells in Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL)
About this study
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)
- Condition
- Relapsed/Refractory B- Cell Non-Hodgkin Lymphoma
- Tested
- CAR-T cells
- Sponsor
- National University of Malaysia
Who can join
- Age
- 13 to 75 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 13
- Minimum age: 13 years
- Maximum age: 75 years
- Study condition: Relapsed/Refractory B- Cell Non-Hodgkin Lymphoma
- Patients with histologically confirmed diagnosed with CD19 positive B cell NHL in accordance with WHO classification
- Patients who are refractory to second-line treatment or patients who relapsed after first-line treatment with no available curative options such as autologous or allogeneic haematopoietic stem cell transplantation (HSCT) or relapse within one year of autologous HSCT
- At least one measurable lesion according to revised IWG response criteria
- Age between ≥13to ≤75 years
- Adequate organ function as defined by a creatinine clearance \>40 ml/min, serum alanine transaminase (ALT) \< 5 times the normal value, serum bilirubin \< 3 times the normal value, left ventricular ejection fraction\> 45%
- Absolute neutrophil count ≥ 1500/μl, haemoglobin level ≥ 7 g/dl, platelets ≥ 50000/μl.
- Life expectancy \>12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Female of childbearing age must have a negative pregnancy test and is on two effective contraception methods
- Male patients must use two effective contraception methods
Exclusion 9
- Active central nervous system (CNS) lymphoma (detected by Imaging study or cerebrospinal fluid (CSF) analysis)
- Active cancer(other than NHL) or receiving cancer treatment
- Evidence of severe lung, heart (New York Heart Association class III/IV, arrhythmia, heart block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder
- Presence of active autoimmune disease requiring immunosuppressive therapy
- Human Immunodeficiency Virus (HIV) positivity
- Active Hepatitis B, and Hepatitis C infection
- Uncontrolled infection
- Pregnant/nursing female.
- Receiving autologous or allogeneic stem cell transplant within 12 weeks of enrolment
Where
1 site, 1 recruiting
Universiti Kebangsaan Malaysia
Bandar Tun Razak, Kuala Lumpur, Malaysia
Contact
-
S Fadilah Abdul Wahid Dr.
+60391456450 sfadilah@hctm.ukm.edu.my
Potential match only. Final eligibility is determined by the study team.