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New treatment option for Lymphoma, Nonhodgkin
Official title Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) Therapy for Treatment of B-cell Hematological Malignancies
ClinicalTrials.gov ID: NCT06462248
What this study is testing
What is CUCART19?
CUCART19 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lymphoma, nonhodgkin.
Also referred to as anti-CD19 CAR-T.
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
- CAR-T therapy is now available as a commercial product for treatment of relapsed /refractory acute lymphoblastic leukaemia and B-lymphoma. There is limited access to this new treatment as the product is very expensive.
- 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 1 and older
You may be able to join if
- Acute Lymphoblastic Leukaemia
- Paediatric or adult patients with relapsed or refractory CD19+ B cell ALL. (Age 0-60 years). Patients should be in first or subsequent relapse, or...
- ECOG performance score of ≤2 if \>16 years old, or Lansky performance score of \>50 if ≤16 years old at screening
- Post allogeneic stem cell transplant patients with B cell ALL will be eligible \> 3 months after transplant and off immunosuppression for at least 1...
- Patients with active leukaemia who developed significant organ impairment that cannot tolerate conventional chemotherapy,
You likely can't join if
- of both cohorts
- Patients with active infection
- Patients with B cell ALL post allogeneic transplant with active GVHD or on immunosuppression
- Recent donor lymphocyte infusion (DLI) after allogeneic transplant, less than 6 weeks between DLI and CAR T infusion
- Current autoimmune disease, or history of autoimmune disease with potential CNS involvement
- Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischaemia or haemorrhage...
See the full eligibility criteria
- Acute Lymphoblastic Leukaemia
- Paediatric or adult patients with relapsed or refractory CD19+ B cell ALL. (Age 0-60 years). Patients should be in first or subsequent relapse, or relapse after prior stem cell transplant, or persistent Minimal Residual...
- ECOG performance score of ≤2 if \>16 years old, or Lansky performance score of \>50 if ≤16 years old at screening
- Post allogeneic stem cell transplant patients with B cell ALL will be eligible \> 3 months after transplant and off immunosuppression for at least 1 month.
- Patients with active leukaemia who developed significant organ impairment that cannot tolerate conventional chemotherapy,
- For women of childbearing potential, a negative pregnancy test prior to apheresis B-cell lymphoma
- Patients with histologically confirmed refractory Diffuse Large B-cell Lymphoma, primary mediastinal B cell lymphoma or transformed follicular lymphoma or other B-cell lymphoma according to WHO classification
- Confirmed CD19 positivity status in tissue sample obtained at diagnosis or relapse
- Received at least two prior treatment which must include at least one intensive systemic therapy.
- Disease progression or relapsed disease within 12 months after autologous stem cell transplant
- ECOG performance score of ≤2 if \>16 years old, or Lansky performance score of \>50 if ≤16 years old at screening
- Has sufficient organ function to tolerate treatment with CAR-T cell therapy
- For women of childbearing potential, a negative pregnancy test prior to apheresis
- of both cohorts
- Patients with active infection
- Patients with B cell ALL post allogeneic transplant with active GVHD or on immunosuppression
- Recent donor lymphocyte infusion (DLI) after allogeneic transplant, less than 6 weeks between DLI and CAR T infusion
- Current autoimmune disease, or history of autoimmune disease with potential CNS involvement
- Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischaemia or haemorrhage, dementia, paralysis)
- Patients who are positive for HBsAg, HCV RNA positive or with HIV infection
- Pulmonary function: Grade 1 dyspnea and pulse oxygenation \> 91% on room air
- Cardiac function: Fractional shortening \<28% or left ventricular ejection fraction \<45% by echocardiography.
- Renal function: Creatinine clearance \<50 mL/min/1.73 m2
- Liver function: Patients with a serum bilirubin \>3 times upper limit of normal or an AST or ALT \> 5 times upper limit of normal, unless due to leukaemic liver infiltration in the estimation of the investigator
- Rapidly progressive disease that in the estimation of the investigator would compromise ability to complete study therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 1 year and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, China. 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.