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

NCT ID: NCT06698484

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-03
• Study Completion Date: 2026-06-02

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)

Conditions

Relapsed/Refractory B- Cell Non-Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient will infuse with autologous CD19 CAR-T cells

CD19 CAR-T cells

Group Type: EXPERIMENTAL

CAR-T cells

Intervention Type: DRUG

2×10\^6 CAR T cells/kg

Interventions

CAR-T cells

2×10\^6 CAR T cells/kg

Intervention Type: DRUG

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Plutonet Sdn Bhd

UNKNOWN

Sponsor Role: collaborator

National University of Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universiti Kebangsaan Malaysia

Bandar Tun Razak, Kuala Lumpur, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

S Fadilah Abdul Wahid Dr.

Role: CONTACT

sfadilah@hctm.ukm.edu.my

+60391456450

Facility Contacts

S Fadilah Abdul Wahid Dr.

Role: primary

sfadilah@hctm.ukm.edu.my

+60391456450

Other Identifiers

JEP-2021-224

Identifier Type: OTHER

Identifier Source: secondary_id

CAR-T NHL PTS Plutonet 2021

Identifier Type: -

Identifier Source: org_study_id