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Tests treatment safety and results for Relapsed/Refractory B- Cell Non-Hodgkin Lymphoma
Official title To Evaluate Safety and Efficacy of Autologous CD19 Chimeric Antigen Receptor (CAR)-T Cells in Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL)
ClinicalTrials.gov ID: NCT06698484
What this study is testing
What is CAR-T cells?
CAR-T cells is an investigational medicine, being studied as a potential treatment for relapsed/refractory b- cell non-hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 75
You may be able to join if
- 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...
- 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) \ 45%
You likely can't join if
- 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...
- Presence of active autoimmune disease requiring immunosuppressive therapy
- Human Immunodeficiency Virus (HIV) positivity
- Active Hepatitis B, and Hepatitis C infection
See the full eligibility 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...
- 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) \ 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bandar Tun Razak, Kuala Lumpur, Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bandar Tun Razak, Kuala Lumpur, Malaysia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.