Actively Recruiting
Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) Therapy for Treatment of B-cell Hematological Malignancies
Led by Chi Kong Li · Updated on 2024-06-17
20
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
Sponsors
C
Chi Kong Li
Lead Sponsor
H
Hong Kong Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) Therapy for Treatment of B-cell Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Paediatric or adult patients aged 0-60 years with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia (ALL), including those in first or subsequent relapse, relapse after stem cell transplant, or persistent minimal residual disease positive
- ECOG performance score of 2 or less if older than 16 years, or Lansky performance score above 50 if 16 years or younger at screening
- Post allogeneic stem cell transplant patients with B cell ALL eligible if more than 3 months post-transplant and off immunosuppression for at least 1 month
- Patients with active leukemia who have significant organ impairment and cannot tolerate conventional chemotherapy
- For women of childbearing potential, a negative pregnancy test prior to apheresis
- Patients with histologically confirmed refractory diffuse large B-cell lymphoma, primary mediastinal B cell lymphoma, transformed follicular lymphoma, or other B-cell lymphoma per WHO classification
- Confirmed CD19 positivity in tissue sample at diagnosis or relapse
- Received at least two prior treatments including at least one intensive systemic therapy
- Disease progression or relapse within 12 months after autologous stem cell transplant
- Sufficient organ function to tolerate CAR-T cell therapy
- ECOG performance score of 2 or less if older than 16 years, or Lansky performance score above 50 if 16 years or younger at screening
- For women of childbearing potential, a negative pregnancy test prior to apheresis
You will not qualify if you...
- Active infection
- B cell ALL patients post allogeneic transplant with active graft-versus-host disease or on immunosuppression
- Recent donor lymphocyte infusion less than 6 weeks before CAR-T infusion
- Current autoimmune disease or history of autoimmune disease with potential central nervous system involvement
- Active clinically significant central nervous system dysfunction including uncontrolled seizures, stroke, dementia, or paralysis
- Positive for hepatitis B surface antigen, hepatitis C RNA, or HIV infection
- Pulmonary function with grade 1 dyspnea and oxygen saturation above 91% on room air
- Cardiac function with fractional shortening below 28% or left ventricular ejection fraction below 45% by echocardiography
- Renal function with creatinine clearance below 50 mL/min/1.73 m2
- Liver function with serum bilirubin more than 3 times upper limit of normal or AST/ALT more than 5 times upper limit unless due to leukemic liver infiltration
- Rapidly progressive disease that would compromise ability to complete study therapy as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Hong Kong, China
Actively Recruiting
Research Team
C
Chi Kong Li, MD
CONTACT
Y
Yvonne Chu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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