CAR-T therapy for treating B-cell blood cancers
A Single Arm, Open-labelled Phase II Clinical Trial of Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) for Treatment of B-cell Haematological Malignancies
This study is testing a new way to make CAR-T therapy for patients with relapsed or hard-to-treat B-cell blood cancers to see if it is safe and effective.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Prince of Wales Hospital, Shatin, Hong Kong Academic / other |
| Drugs / interventions | CAR-T, CAR T, chemotherapy, CART |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06462248 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety and effectiveness of CD19 specific CAR-T cells produced using the CliniMACS prodigy system for patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) and B-cell Non-Hodgkin Lymphoma (NHL). The study aims to develop a cost-effective, point-of-care manufacturing system for CAR-T cells, which are critical for treating these hematological malignancies. Participants will undergo lymphapheresis to collect their T-cells, which will then be processed and activated in a certified GMP facility. The trial will be conducted at Prince of Wales Hospital and Hong Kong Children's Hospital, focusing on both pediatric and adult patients.
Who should consider this trial
Good fit: Ideal candidates include pediatric and adult patients aged 0-60 with relapsed or refractory CD19+ B-cell ALL or specific types of B-cell NHL.
Not a fit: Patients with non-CD19+ B-cell malignancies or those who are not in a relapsed state may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more accessible and cost-effective treatment option for patients with relapsed B-cell malignancies.
How similar studies have performed: Other studies have shown success with CAR-T therapies, but this specific approach using the CliniMACS prodigy system is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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 ≤2 if \>16 years old, or Lansky performance score of \>50 if ≤16 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.
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, China (Recruiting)
Study contacts
- Principal investigator: Chi Kong Li, MD — Chinese University of Hong Kong
- Study coordinator: Chi Kong Li, MD
- Email: ckli@cuhk.edu.hk
- Phone: 852-35051019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.