NCT06698484 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 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National University of Malaysia |
| Condition | Relapsed/Refractory B- Cell Non-Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-06-03 |
| Primary Completion | 2025-06-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2021-06-03 with a primary completion date of 2025-06-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06698484 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 75 Years, studying Relapsed/Refractory B- Cell Non-Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06698484 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06698484 currently recruiting?
Yes, NCT06698484 is actively recruiting participants. Contact the research team at sfadilah@hctm.ukm.edu.my for enrollment information.
Where is the NCT06698484 trial being conducted?
This trial is being conducted at Bandar Tun Razak, Malaysia.
Who is sponsoring the NCT06698484 clinical trial?
NCT06698484 is sponsored by National University of Malaysia. The trial plans to enroll 20 participants.