To Evaluate Safety and Efficacy of Autologous CD19 Chimeric Antigen Receptor (CAR)-T Cells in Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL) (CAR-T for NHL)

National University of Malaysia

Status and phase: Enrolling; Phase 2

Conditions: Relapsed/Refractory B- Cell Non-Hodgkin Lymphoma

Treatments: Drug: CAR-T cells

Study type: Interventional

Funder types: Other

Identifiers

NCT06698484

JEP-2021-224 (Other Identifier)

CAR-T NHL PTS Plutonet 2021

Details and patient eligibility

About

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)

Enrollment: 20 estimated patients

Sex: All

Ages: 13 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Patient will infuse with autologous CD19 CAR-T cells

Experimental group

Description:

CD19 CAR-T cells

Treatment:

Drug: CAR-T cells