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B-Cell Non Hodgkin LymphomaPhase 1NCT06027957

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

A Phase 1 study testing anti-CD19 CAR T-cells in people with B-Cell Non Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 1 year to 60 years
What is being tested?
anti-CD19 CAR T-cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteVietnam
Study dates
2 Aug 2023to 31 Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
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  • 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
  • Agree to use safe methods of contraception for female patients.

Who cannot join

  • 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.
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  • 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).
  • Unstable angina within 3 months prior to screening.
  • Any previous or concurrent malignancy was not B-cell lymphoma or B-ALL.
  • Medical history of clinically relevant central nervous system disease, such as epilepsy, convulsions, paralysis, aphasia, uncontrolled cerebrovascular disease, traumatic brain injury, and Parkinson's disease.
  • Intolerance to excipients from cellular products.
  • Pregnant women or those who expect to be pregnant or reastfeeding.
  • Other diseases or other conditions and circumstances that, according to the investigator's assessment, make it difficult to ensure compliance with study treatment.
  • Participation in another clinical trial at the time of screening

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Vinmec Research Institute of Stem Cell and Gene Technology

    Hanoi, Hanoi, 100000

Other trials in Vietnam

About this study

Official title: Phase I Clinical Trial Evaluating the Safety and Efficacy of Point-of-care CAR-T-cell Therapy in the Treatment of Relapsed/Refractory CD19+ Non-Hodgkin Lymphoma and Acute Lymphoblastic Leukemia

  • 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.
Read the detailed description

Objectives:

  • Evaluate the frequency and severity of adverse events and serious adverse events (AEs/SAEs) of the therapy.
  • Evaluate the response rate after CD19 CAR T-cell infusion according to the following criteria:
  • Proportion of patients with complete response and partial response after CD19 CAR T-cell infusion
  • Progression-free survival (PFS) after infusion of CD19 CAR T-cells
  • Event-free survival (EFS) after infusion of CD19 CAR T-cells
  • Overall survival (OS) after infusion of CD19 CAR T-cells
Being tested
anti-CD19 CAR T-cells
Medical subject headings
Lymphoma, B-Cell, Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-CD19 CAR T-cellsBiological

    Also called Chemotherapy Drug

    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.
Study groups in NCT06027957
Study groupRoleWhat they receive
Treatment RegimenExperimental* 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.
Receives: Biological: anti-CD19 CAR T-cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (4)

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

    Patients with B-ALL will receive bone marrow biopsy assessed on day 30 and day 90 to check blast frequency and MRD. The response will be classified according to NCCN guidelines.

    Patients with NHL will be examined PET-CT or CT on day 90. The response will be classified according to Cheson guidelines.

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

  2. Progression-free survival (PFS) (months)

    PFS is defined as the time from CAR T-cell infusion, until disease progression or death from any cause. Progression is defined as an increase of tumor load, the development of new lesions.

    Measured: 6 months

  3. Event-free survival (EFS) (months)

    EFS is defined as time to treatment failure (including complete remission with incomplete hematologic or platelet recovery), relapse from complete remission, or death from any cause.

    Measured: 6 months

  4. Overall survival (OS) (months)

    EFS is defined as time to death

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2023
  2. Study start2 Aug 2023
  3. Primary completion30 Jun 2025
  4. Study completion31 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06027957
Sponsor's protocol ID
ISC19.26
Status last verified
Aug 2025
First submitted
28 Jul 2023
Last updated
26 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing anti-CD19 CAR T-cells in people with B-Cell Non Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the frequency and severity of adverse events and serious adverse events (AEs/SAEs) of the therapy (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06027957.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.

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