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

NCT06027957 | Completed Phase 1 DMC

• 1 other identifier: ISC19.26
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

• Brief Summary: Cluster of differentiation 19 (CD19) is expressed on B cells. CD19+ tumor cells in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia can be targeted using T cells expressing CD19-specific chimeric antigen receptor (CAR).
• Objective: This study aims to evaluate the safety and efficacy of single-dose anti-CD19 CAR T-cell therapy in the treatment of relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia.
• Eligibility: People aged 1 to 60 years with relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia.
• Design: Phase 1 clinical trial, uncontrolled, single dose of CD19 CAR T-cells.

Conditions

B-Cell Non Hodgkin Lymphoma; B-Cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Assessment of the frequency and severity of adverse events and serious adverse events (AEs/SAEs) of the therapy

  The incidence of adverse events (AEs) and serious adverse events (SAEs) will be recorded and classified according to CTCAE v5 (grade 1-5). CRS and ICANs will be classified using the ASTCT criteria (grade 1-5). These parameters will be used to assess the safety of the therapy.

  6 months

Secondary Outcomes (4)

• Proportion of patients with complete response and partial response after CD19 CAR T-cell infusion (%)

  Day 30 and day 90 after CAR-T infusion for B-ALL; day 90 after CAR-T infusion for NHL

• Progression-free survival (PFS) (months)

  6 months

• Event-free survival (EFS) (months)

  6 months

• Overall survival (OS) (months)

  6 months

Study Arms (1)

Treatment Regimen

EXPERIMENTAL

* Experimental: Treatment Regimen. * Leukapheresis to collect white blood cells using Spectra Optia Apheresis system. * T cells selection, transduction, and CAR T-cell manufacturing using CliniMACS Prodigy. During this process, T cells will be genetically modified to express CD19 CAR. * Lymphodepleting chemotherapy conditioning regimen for 3 days. * CAR T-cells targeting CD19 will be infused intravenously at a dose between 1 and 2x10e6 cells/kg for 15-30 minutes. * Following the T-cell infusion, patients will stay in the clinic for approximately 21-28 days to monitor toxicity. * Outpatient follow-up will take place after 1 month, 3 months, and 6 months after infusion.

Biological: anti-CD19 CAR T-cells

Interventions

anti-CD19 CAR T-cells BIOLOGICAL

For Biological: CD19 CAR T-cells * Dose: 1-2.10e6 cells/kg of weight * Route: intravenous infusion For Chemotherapy Drug: * Fludarabine (30 mg/m2/day) given intravenously (IV) on day -5 to -3. * Cyclophosphamide 500 mg/m2/day for NHL and 250 mg/m2/day for ALL given IV from day -5 to -3. * Mesna 500 mg/m2/day for NHL and 250 mg/m2/day for ALL, divided in three infusions: one day before the cyclophosphamide infusion, and 4 and 8 hours after.

Also known as: Chemotherapy Drug

Treatment Regimen

Eligibility Criteria

• Age: 1 Year - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• B-cell acute lymphoblastic leukemia: refractory to two cycles of chemotherapy, relapsed after chemotherapy, or hematopoietic stem cell transplantation.
• B-cell non-Hodgkin lymphoma: refractory to two lines of chemotherapy, relapsed after chemotherapy, or hematopoietic stem cell transplantation.
• Age: From 1 to 60 years old (both males and females)
• Adequate organ functions:
• Serum creatinine ≤ 1.5 x ULN or eGFR ≥ 60 mL/min/1.73 m2
• ALT and AST ≤ 5 x ULN; Bilirubin ≤ 2.0 mg/dl
• No chronic lung diseases, such as obstructive pulmonary disease or bronchial asthma, required continuous medications without respiratory failure (SpO2 oxygen saturation \> 92% at room temperature).
• No arrhythmia, no intracardiac thrombus or vascular wall, no heart failure, LVEF ≥ 45%
• Blood test:
• Absolute neutrophil count (ANC) ≥ 1,000/mm3 (1 G/l) without filgrastim
• Absolute lymphocyte count ≥ 100/mm3 (0.1 G/l)
• Absolute platelet count ≥ 75,000/mm3 (75 G/l)
• Hemoglobin ≥ 8.0 g/dl
• Positive for CD19 measured by immunohistochemistry or flow cytometry.
• Agree to participate in the study

You may not qualify if:

• Involved central nervous system invasion at the time of screening.
• Medical history of veno-occlusive disease (VOD).
• Required acute treatment due to tumors such as intestinal obstructions, vascular compression, or respiratory failure.
• Having active hemolytic anemia.
• Diagnosed with primary immunodeficiency.
• Medical history of autoimmune neurological diseases or neuromyelitis.
• Receiving immunosuppressive medication, except for ≤ 30 mg prednisolone or equivalent at the time of CAR-T-cell transfusion.
• Having acute, progressive, or chronic graft-versus-host disease (GvHD).
• Having active infectious diseases determined by clinical, imaging, or other laboratory tests (blood culture, PCR, etc.)
• Patients who are critically ill or at risk of premature death characterized by:
• Acute liver failure requiring dialysis
• Heart failure requiring vasopressors
• Systemic infection unresponsive to antibiotics
• ECOG performance status ≥ 3 points at the time of screening
• Having other severe concomitant diseases (e.g., uncontrolled arterial hypertension, heart failure NYHA III-IV).

Sponsors & Collaborators

• Vinmec Research Institute of Stem Cell and Gene Technology: lead
• National Institute of Hematology and Blood Transfusion, Vietnam: collaborator

Study Sites (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Hanoi, 100000, Vietnam

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Study Officials

• Thanh Liem Nguyen, PhD

  Vinmec Research Institute of Stem Cell and Gene Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: September 7, 2023
• Study Start: August 2, 2023
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)