Evaluating CAR-T Cell Therapy for Relapsed B-Cell Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II open-label study aims to assess the safety and efficacy of autologous CD19-directed CAR T-cells in patients with relapsed or refractory B-cell non-Hodgkin lymphoma who are not eligible for hematopoietic stem cell transplantation. The study will involve patients who have histologically confirmed CD19 positive B-cell NHL and have not responded to previous treatments. Participants will receive locally manufactured CAR-T cells and will be monitored for treatment outcomes and safety.

Why it matters

Who can join: the full rules

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

Where it's running

• Universiti Kebangsaan Malaysia
  Bandar Tun Razak, Kuala Lumpur, Malaysia Recruiting

Study contacts

• Study coordinator: S Fadilah Abdul Wahid Dr.
• Email: sfadilah@hctm.ukm.edu.my
• Phone: +60391456450

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.