CD19 CAR T-Cell Therapy for R/​R Non-Hodgkin Lymphoma and Acute Lymphoblastic Leukemia

Overview

Non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL) are malignant hematologic diseases that often progress rapidly, are life-threatening, and require intensive, prolonged treatment. Although current standard regimens such as chemotherapy, chemo-immunotherapy, and hematopoietic stem cell transplantation have significantly improved prognosis for many patients, a substantial proportion still experience relapse or are refractory to treatment, with very poor outcomes. This highlights an urgent need for newer, more effective and more personalized therapies.
Biologically, malignant B cells in NHL and ALL frequently express the surface molecule Cluster of Differentiation 19 (CD19). This feature allows the use of CD19-specific chimeric antigen receptor T cells (CD19 CAR T-cells) to selectively recognize and eliminate CD19+ tumor cells.
Study objective
To evaluate the safety and efficacy of a single dose of CD19-targeted CAR T-cell therapy in patients with relapsed or refractory CD19+ NHL and ALL. This is an open-label, single-arm Phase I clinical trial in which patients receive a single infusion of CD19 CAR T-cells.

Inclusion Criteria

Diagnosis
– B-cell ALL: relapsed or refractory after ≥2 cycles of chemotherapy or after hematopoietic stem cell transplantation.
– B-cell NHL: relapsed or refractory after ≥2 chemotherapy regimens or after hematopoietic stem cell transplantation.
1–60 years, male or female.
Organ function requirements
– Kidney: Creatinine ≤ 1.5 × upper limit of normal (ULN) or eGFR ≥ 60 mL/min/1.73 m².
– Liver: ALT/AST ≤ 5 × ULN; bilirubin ≤ 2.0 mg/dL.
– Heart: Left ventricular ejection fraction (LVEF) ≥ 45%, no heart failure, no severe arrhythmias.
– Lungs: SpO₂ > 92% on room air, no severe chronic lung disease.
Laboratory tests
– Absolute neutrophil count (ANC) ≥ 1,000/mm³
– Platelets ≥ 75,000/mm³
– Hemoglobin (Hb) ≥ 8 g/dL
Tumor cells are CD19+ (confirmed by immunohistochemistry or flow cytometry).
Patient agrees to participate in the study and to use appropriate contraceptive measures (if female).

Exclusion Criteria

Central nervous system involvement at the time of screening.
History of severe disease, including:
– Veno-occlusive disease (VOD)
– Acute liver failure, severe heart failure (NYHA III–IV), or requiring vasopressor support
– Neurologic autoimmune disease (e.g., neuromyelitis)
– Primary immunodeficiency.
– Active infection or systemic infection not responding to treatment.
– Acute, progressive, or chronic graft-versus-host disease (GvHD).
– Current use of immunosuppressive drugs, except ≤30 mg prednisolone (or equivalent).
– Critical condition or poor short-term prognosis (ECOG performance status ≥3).
– Severe uncontrolled comorbidities (e.g., uncontrolled hypertension, heart failure, unstable angina).
– Malignancies other than B-cell lymphoma or B-ALL.
– Clinically significant central nervous system disorders (seizures, stroke, Parkinson’s disease, etc.).
– Hypersensitivity or intolerance to any excipient of the cell product.
– Pregnant or breastfeeding, or planning to become pregnant.
– Participation in another clinical trial at the time of screening.

PI

Prof. MD Nguyễn Thanh Liêm – Vinmec Research Institute of Stem Cell and Gene Technology (VRISG), Vinmec Times City Internation Hospital

Contact