Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) Therapy for Treatment of B-cell Hematological Malignancies
Recruiting
Phase 2Interventional Study
Lymphoma, NonhodgkinLeukemia, Lymphocytic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
1 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Chi Kong Li · Other
Who this trial is looking for
This trial is looking for patients with certain types of B-cell blood cancers. Participants will receive CAR-T cell therapy made locally to see if it is safe and effective.
Are You a Good Fit for This Trial?
You may be able to join if
I have relapsed or refractory acute lymphoblastic leukaemia and am between 0-60 years old.
I have refractory B-cell lymphoma confirmed by a doctor.
I have received at least two treatments for my lymphoma.
I have a performance score of 2 or less.
I have enough organ function to tolerate treatment.
I am at least 3 months post stem cell transplant and off immunosuppression for at least 1 month.
I have a negative pregnancy test if I am a woman who can get pregnant.
You may not be able to join if
I have an active infection.
I have had a recent donor lymphocyte infusion.
I have current or past autoimmune disease that affects my brain.
I have active central nervous system problems.
I am positive for certain viral infections like HIV or Hepatitis.
I have severe lung, heart, kidney, or liver issues.
I have a rapidly progressing disease that might impact my treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 Biotec…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility 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 dis…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.