CAR-T therapy for treating B-cell blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

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• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

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• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

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• Using golcadomide and rituximab to prepare patients for CAR T-cell therapy in aggressive B-cell lymphoma

  This study is testing if a combination of golcadomide and rituximab can help patients with aggressive B-cell lymphoma get ready for CAR T-cell therapy.

  Recruiting at 7 sites Phase 2 Mayo Clinic · Scottsdale, Arizona and 6 other locations · NCT06834373

• Loncastuximab tesirine plus rituximab as bridging therapy before CAR-T for relapsed or refractory large B‑cell lymphoma

  This trial tries loncastuximab tesirine with rituximab as a bridge before commercial CD19 CAR‑T therapy for adults with relapsed or refractory large B‑cell lymphoma to see if it is safe and helps control disease before CAR‑T.

  Recruiting at 2 sites Phase 2 University of Utah · Chapel Hill, North Carolina and 1 other locations · NCT06788964

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.