Relapsed/Refractory B- Cell Non-Hodgkin Lymphoma
Conditions
Keywords
RR B- NHL, CD19 CAR-T cells, malaysia
Brief summary
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)
Interventions
DRUGCAR-T cells
2×10\^6 CAR T cells/kg
Sponsors
Plutonet Sdn Bhd
National University of Malaysia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | From day 30, then 3 monthly until 24 months after infusion of CAR-T cells | The ORR is the sum of patients achieving complete response (CR) and partial response (PR) at day 30, then 3 monthly up to 24 months after receiving CAR T-cells determined by the investigator following Lugano criteria in non-Hodgkin Lymphoma (NHL). Response assessment will be determined using a PET CT scan, or other relevant imaging studies and compared to the baseline (pre-CAR-T infusion) study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | OS at day 30, 6 months and one year, and 2 years following CAR-T cells infusion | Overall survival (OS) is defined as the time from the date of CAR-T cell infusion to the date of death from any cause. Patients who are still alive will be censored at the date of last contact. |
| Incidence of adverse events | From the time of infusion up to 24 months after infusion of CAR-T cells | Cumulative incidence of CAR-T cell treatment-related adverse events (AEs) graded by ASCT consensus grading criteria for cytokine release syndrome (CRS) and Immune Effector cell-associated Neurotoxicity Syndrome (ICANS) and by common terminology criteria adverse events (CTCAE) versions 5.0 for other AEs in p\[articular hematotoxicity and infection. |
Countries
Malaysia
Contacts
Primary ContactS Fadilah Abdul Wahid Dr.
Outcome results
None listed