Clinical trial NCT06698484: To Evaluate Safety and Efficacy of Autologous CD19 Chimeric Antigen Receptor (CAR)-T Cells in Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Relapsed/Refractory B- Cell Non-Hodgkin Lymphoma
Keywords: RR B- NHL
CD19 CAR-T cells
malaysia
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
Collaborators: name: Plutonet Sdn Bhd
First posted: 2024-11-21
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: From day 30, then 3 monthly until 24 months after infusion of CAR-T cells
Secondary outcomes:
measure: overall survival
timeFrame: OS at day 30, 6 months and one year, and 2 years following CAR-T cells infusion
measure: Incidence of adverse events
timeFrame: From the time of infusion up to 24 months after infusion of CAR-T cells
Other outcomes:
Locations:
city: Bandar Tun Razak
country: Malaysia
facility: Universiti Kebangsaan Malaysia
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
References: