Universiti Kebangsaan Malaysia
Bandar Tun Razak, Kuala Lumpur, Malaysia
Location status: Recruiting
Location contact
S Fadilah Abdul Wahid Dr
PRINCIPAL_INVESTIGATOR
S Fadilah Abdul Wahid Dr.
CONTACT
NCT Number: NCT06698484
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)
Interested in participating?
Request Info13 year–75 year
All sexes
Interventional
Phase 2
Bandar Tun Razak, Kuala Lumpur, Malaysia
Location status: Recruiting
S Fadilah Abdul Wahid Dr
PRINCIPAL_INVESTIGATOR
S Fadilah Abdul Wahid Dr.
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2×10^6 CAR T cells/kg
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
National University of Malaysia
Other
A Phase II Open Label Single-arm Study to Evaluate Safety and Efficacy of Autologous CD19 CAR-T Cells in Patients With Relapsed/Refractory B- Non-Hodgkin Lymphoma
Acronym: CAR-T for NHL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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