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Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) Therapy for Treatment of B-cell Hematological Malignancies

RecruitingPhase 2Ages 1 Year - anyAllChi Kong Li
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In plain words

What the trial is, and whether it could suit you

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. It is imperative to develop cost effective, closed circuit manufacturing systems for CAR-T cells to make CAR-T cells a point-of care production option. Hong Kong Institute of Biotechnology has established a certified GMP facility and utilize the Prodigy system to manufacture CAR-T cells for clinical application. Prince of Wales Hospital and Hong Kong Children's Hospital will conduct the phase II clinical trial to confirm the efficacy and safety of local manufactured CAR-T cell product.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion 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 Disease (MRD) positive disease * ECOG performance score of โ‰ค2 if \>16 years old, or Lansky performance score of \>50 if โ‰ค16 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 โ‰ค2 if \>16 years old, or Lansky performance score of \>50 if โ‰ค16 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 Exclusion criteria 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.
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What it tests

  • CUCART19
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Where

1 site
Prince of Wales Hospital
Hong Kong, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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