Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) Therapy for Treatment of B-cell Hematological Malignancies
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1+
SponsorChi Kong Li
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
CUCART19
Druganti-CD19 chimeric antigen receptor modified T-cell (CAR-T)
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: single armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Production efficiency of CAR-T cell manufacturing
At least 90% of patients enrolled should be able to achieve successful production of CAR T cells as deomonstrated by CAR-T cell proliferation and persisteance of CAR-T cells in recipients for at least one month after infusion
Time frame
18 monthsSecondary outcomes
1
survival outcome
Achieve a leukemia free survival at 3 months of 60% or higher, and overall survival of B cell ALL patients at 6 months of 50% or higher. Overall and progression free survival of patients with B cell NHL
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chi Kong Li
Lead sponsor
Prince of Wales Hospital, Shatin, Hong Kong
Sponsor institution
Hong Kong Children's Hospital
Collaborator
Source ClinicalTrials.gov