Evaluating CAR-T Cell Therapy for Relapsed B-Cell Lymphoma
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
This study is testing a new CAR-T cell therapy to see if it can help people with relapsed B-cell lymphoma who haven't responded to other treatments and can't have a stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 13 Years to 75 Years |
| Sex | All |
| Sponsor | National University of Malaysia Academic / other |
| Drugs / interventions | CAR T |
| Locations | 1 site (Bandar Tun Razak, Kuala Lumpur) |
| Trial ID | NCT06698484 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients aged 13 to 75 with confirmed CD19 positive B-cell NHL who have relapsed after first-line treatment or are refractory to second-line treatment.
Not a fit: Patients who have not been diagnosed with CD19 positive B-cell NHL or those who are eligible for hematopoietic stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with limited alternatives for relapsed or refractory B-cell non-Hodgkin lymphoma.
How similar studies have performed: Other studies involving CAR-T cell therapies have shown promising results, indicating potential success for this approach in treating similar conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bandar Tun Razak, Kuala Lumpur
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.