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
Qualifiers
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
Treatments tested in this trial
- CUCART19
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Chi Kong Li
Lead sponsor
Prince of Wales Hospital, Shatin, Hong Kong
Sponsor institution
Hong Kong Children's Hospital
Collaborator
Source ClinicalTrials.gov