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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
2×10\^6 CAR T cells/kg
Universiti Kebangsaan Malaysia
Bandar Tun Razak, Kuala Lumpur, Malaysia
RECRUITINGOverall response rate (ORR)
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.
Time frame: From day 30, then 3 monthly until 24 months after infusion of CAR-T cells
overall survival
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.
Time frame: OS at day 30, 6 months and one year, and 2 years following CAR-T cells infusion
Incidence of adverse events
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.
Time frame: From the time of infusion up to 24 months after infusion of CAR-T cells
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