Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) Therapy for Treatment of B-cel
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 m
| Condition(s) | Lymphoma, Nonhodgkin, Leukemia, Lymphocytic |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 ≤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 |
| Ages | 1 Year |
| Sex | All |
| Lead sponsor | Chi Kong Li |
| Locations | Hong Kong, China |
| Start date | 2024-06-01 |
| NCT ID | NCT06462248 |
| Official listing | https://clinicaltrials.gov/study/NCT06462248 |