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Diffuse Large B Cell LymphomaPhase 1NCT04067414

Exploratory Study of CD19-targeted Chimeric Antigen Receptor T Cells(BZ019) for Relapsed and Refractory B-cell Lymphoma

A Phase 1 study testing BZ019 in people with Diffuse Large B Cell Lymphoma and High-grade B-cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

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

This is an open-label, multicenter, dose-escalation phase 1 study to determine the safety and efficacy of BZ019 in relapsed or refractory CD19+ B-cell Lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BZ019
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
8 Jun 2018to 4 Jun 2021
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent must be obtained prior to any screening procedures
  • Age ≥ 18 years subjects with Relapsed or refractory large B-cell lymphoma, including: DLBCL,NOS, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, transformed B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBCL).
  • No response for the last chemotherapy:
  • Progressive disease after the last chemotherapy or
  • Stable disease after the last chemotherapy, and the maintenance time for stable disease was no longer than 6 month after last dose.
  • Either having failed autologous Hematopoietic stem cell transplantation (ASCT), or being ineligible for or not consenting to ASCT
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  • Refractory disease after ASCT or relapsed disease within 12 months after last ASCT (histologically confirmed) or
  • No response or relapsed disease for the last therapy after ASCT.
  • Subjects must be accepted adequate treatment, including at least:
  • Treated by CD20 monoclonal antibody (Rituximab) except for CD20 negative.
  • Chemotherapy including anthracycline
  • Measurable disease at time of enrollment according to the revised international working group response criteria for malignant lymphoma.
  • Life expectancy ≥12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening.
  • Adequate organ function:
  • Renal function defined as:
  • A serum creatinine of ≤1.5 x Upper Limit of Normal(ULN) or
  • Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73 m2
  • Liver function defined as:
  • Alanine Aminotransferase (ALT) ≤ 5 times the ULN for age
  • Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert-Meulengracht syndrome; patients with Gilbert-Meulengracht syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
  • Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation > 91% on room air
  • Hemodynamically stable and Left Ventricle Ejection Fraction (LVEF) ≥ 45% confirmed by echocardiogram or Multigated Radionuclide Angiography (MUGA)
  • Adequate bone marrow reserve without transfusions defined as:
  • Absolute neutrophil count (ANC) > 1000/μL
  • Absolute lymphocyte count (ALC) ≥ 300/μL
  • Platelets ≥ 50000/μL
  • Hemoglobin > 8.0 g/dl
  • Must have an apheresis product of non-mobilized cells accepted for manufacturing.
  • The following medications are excluded:
  • Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to BZ019 infusion. However, the following physiological replacement doses of steroids are allowed: < 6 - 12 mg/m2/day hydrocortisone or equivalent
  • Immunosuppression: Any immunosuppressive medication must be stopped ≥ 4 weeks prior to enrollment
  • Antiproliferative therapies other than lymphodepleting chemotherapy within two weeks of infusion
  • Antibody use including anti-CD20 therapy within 4 weeks prior to infusion or 5 half-lives of the respected antibody, whichever is longer
  • CNS disease prophylaxis must be stopped > 1 week prior to BZ019 infusion (e.g. intrathecal methotrexate)
  • Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants must agree to use highly effective methods of contraception for at least 12 months following BZ019 infusion and until CAR T cells are no longer present by PCR on two consecutive tests

Who cannot join

  • Prior treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy
  • Treatment with any prior gene therapy product, include CAR-T cell therapy.
  • Active Central Nervous System (CNS) involvement by malignancy or secondary CNS involvement
  • History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or self-immune disease with CNS involvement.
  • Prior allogeneic HSCT
  • Eligible for and consenting to ASCT
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  • Chemotherapy other than lymphodepleting chemotherapy within 2 weeks of infusion
  • Investigational medicinal product within the last 30 days prior to screening
  • Prior radiation therapy within 2 weeks of infusion
  • Active replication of or prior infection with hepatitis B or active hepatitis C( HCV RNA positive )
  • HIV positive patients
  • Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
  • Unstable angina and/or myocardial infarction within 6 months prior to screening
  • Previous or concurrent malignancy with the following exceptions:
  • Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)
  • In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study
  • A primary malignancy which has been completely resected and in complete remission for ≥ 5 years
  • Pregnant or nursing (lactating) women
  • Cardiac arrhythmia not controlled with medical management
  • Patients on oral anticoagulation therapy within 1 week prior to BZ019 infusion.
  • Prior treatment with any adoptive T cell therapy
  • Patients with active neurological auto immune or inflammatory disorders(e.g. Guillain Barre Syndrome, Amyotrophic Lateral Sclerosis)
  • Other protocol-related inclusion/exclusion may apply.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, 300020

Other trials in China

About this study

Official title: A Single Cohort, Open-label, Multicenter, Dose-escalation Study of Safety and Efficacy of BZ019 for Adult CD19 Positive Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

This is an open-label, multicenter, dose-escalation phase 1 study to determine the safety and efficacy of BZ019 in relapsed or refractory CD19+ B-cell Lymphoma.

Read the detailed description

This is an open-label, multicenter, phase 1 study to determine the safety and antitumor activity of BZ019 in adult patients with R/R large B cell lymphoma (DLBCL),including: DLBCL, not otherwise specified (NOS), transformed DLBCL, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements and primary mediastinal B-cell lymphoma (PMBCL).The safety and efficacy of a single dose of different target doses of BZ019 will be evaluated in the dose-escalation phase and dose-expansion phase.

Upon enrollment, subjects will undergo leukapheresis to enable BZ019 product generation. A baseline tumor biopsy (in subjects with accessible disease) and bone marrow aspirate and biopsy will be obtained.

Upon successful BZ019 product generation, subjects will enter the treatment phase and receive BZ019 infusion. A completed treatment program will include lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by single-dose of BZ019 infusion. BZ019 will be administered 2 to 14 days after the completion of lymphodepleting chemotherapy.

After the infusion of BZ019, subjects will be in the follow-up period upon 12 months for evaluation the safety and efficacy of BZ019. Subjects will be followed for long-term safety, overall survival even after disease progression.

Being tested
BZ019
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • BZ019Biological

    Subjects will be enrolled in three dose-groups:

    Dose 1: 1×10^6/kg CAR+ cells; Dose 2: 3×10^6/kg CAR+ cells; Dose 3: 6×10^6/kg CAR+ cells.

Study groups in NCT04067414
Study groupRoleWhat they receive
BZ019 treatmentExperimentalSubjects will receive lymphodepleting chemotherapy of fludarabine and cyclophosphamide (flu/cy) followed by single-dose of BZ019 infusion. A 3×3 dose escalation design of BZ019 will be adopted.
Receives: Biological: BZ019

What is being measured

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

  1. Number of adverse events

    Number of BZ019 therapy associated adverse events, such as cytokine release syndrome(CRS), chimeric antigen receptor (CAR)-T cell related encephalopathy syndrome(CRES) or other adverse events.

    Measured: up to 1 year after BZ019 infusion.

Secondary outcomes (2)

  1. proliferation of BZ019 in vivo

    measured by PCR

    Measured: up to 1 year after BZ019 infusion.

  2. Overall response rate

    CR+PR

    Measured: up to 1 year after BZ019 infusion.

Timeline

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

  1. First posted26 Aug 2019
  2. Study start8 Jun 2018
  3. Primary completion4 Jun 2021
  4. Study completion4 Jun 2021

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
Sequential
Model description
A treatment program will include lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by single-dose of BZ019 administered intravenously (IV). A 3×3 dose escalation design of BZ019 will be adopted.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04067414
Sponsor's protocol ID
QT2018002
Status last verified
May 2024
First submitted
7 Jan 2019
Last updated
11 Feb 2026
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 BZ019 in people with Diffuse Large B Cell Lymphoma and High-grade B-cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

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 36 inclusion and 23 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 11 Feb 2026. 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 China. 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?

Number of adverse events (time frame: up to 1 year after BZ019 infusion.). 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 NCT04067414.

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 11 Feb 2026.

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