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Large B-cell LymphomaPhase 2NCT05472610

Study of Efficacy of BZ019 in Large B-cell Lymphoma

A Phase 2 study testing BZ019 in people with Large B-cell Lymphoma, run by Shanghai Mengchao Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single arm,open-label, non-randomized phase 2 study to determine the efficacy of BZ019 in relapsed or refractory CD19+ B-cell Lymphoma subjects. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Large B-cell Lymphoma
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
36 participants
Where
1 siteChina
Study dates
4 Jun 2021to Jan 2023
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1）Written informed consent must be obtained prior to any screening procedures;
  • 2）75 ≥Age ≥ 18 years subjects；
  • 3）Subjects who meet the following diagnostic and therapeutic requirements when screening: A）The diagnosis of B Cell NHL was consistent with WHO classification in 2017；
  • B） Subjects must be accepted adequate treatment before and have received at least 2 lines of treatment or relapse or progress after autologous hematopoietic stem cell transplantation, and the treatment history at least include:
  • a）Treatment by CD20 monoclonal antibody (Rituximab) except for CD20 negative; b) A chemotherapy regimen containing anthracyclines.
  • C）With Relapsed or refractory large B-cell lymphoma when screening:
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  • The definition of relapsing is as follows：PD occurs at least after remission (including PR or CR) with standard therapy (including Rituximab) b) The definition of refractory is as follows: i) No response to the last treatment, including:The best response to the latest treatment is PD or SD; ii)Disease progression after ASCT or recurrence within ≤ 12 months (recurrence must be confirmed by biopsy), or if receiving remedial treatment after ASCT, the subject must have no reaction or recurrence after the last treatment.
  • CD19+ which was detected by immunocytochemistry or flow cytometric ;
  • 4)According to the preliminary evaluation, staging and response evaluation recommendations for Hodgkin and non Hodgkin's lymphoma (2014 Edition), at least one measurable lesion was found in the screening period：the length diameter of the intranodal lesion was greater than 1.5cm,the diameter of the external lesion was greater than 1.0cm;
  • 5) Life expectancy ≥12 weeks;
  • 6)Baseline Eastern Cooperative Oncology Group (ECOG) score is 0 or 2 Baseline Eastern Cooperative Oncology Group (ECOG) score is 0 or 2 ;
  • 7)Adequate organ function:
  • A)Renal function defined as:
  • a）A serum creatinine of ≤1.5 x ULN or Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73 m^2;
  • B）Liver function defined as:
  • Alanine Aminotransferase (ALT) ≤ 5 x ULN；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; c） Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation > 91% on room air；
  • 8)Hemodynamically stable and Left Ventricle Ejection Fraction (LVEF) ≥ 50%, confirmed by echocardiogram or Multigated Radionuclide Angiography (MUGA)；
  • 9)No blood transfusion within 1 week before signing the informed consent, sufficient bone marrow reserve is available, which is defined as: A）Absolute neutrophil count (ANC) >1x10^9/L; B）Absolute lymphocyte count (ALC) ≥ 0.5x10^9/L; C）Platelets ≥ 50x10^9/L; D）Hemoglobin > 80 g/L, for patients with bone marrow invasion, hemoglobin > 60g/L can be considered into the group;
  • 10)Must have an apheresis product of non-mobilized cells accepted for manufacturing;
  • 11)If the patient uses the following drugs, the following conditions should be met: A)glucocorticoids: The treatment dose of glucocorticoids must be stopped 72 hours before BZ019 infusion. However, glucocorticoids of physiological alternative dose are allowed: prednisone or its equivalent ≤ 15 mg / day; B)Immunosuppression: Any immunosuppressive medication must be stopped ≥ 4 weeks prior to enrollment; C) Antiproliferative therapies other than lymphodepleting chemotherapy within two weeks of infusion; D) Antibody use including anti-CD20 therapy within 4 weeks prior to infusion or 5 half-lives of the respected antibody, whichever is longer; E)CNS disease prophylaxis must be stopped > 1 week prior to BZ019 infusion (e.g. intrathecal methotrexate);
  • 12)Women of child-bearing age and all male subjects must agree to use effective contraceptive methods until BZ019 are no longer present in the body (detected by PCR).

Who cannot join

  • • Patients who have previously received any anti-CD45, anti-CD19 or anti-CD3 therapy;
  • Patients who have previously received any adoptive T cell therapy or gene therapy products, including CAR-T 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.
  • Patients with positive hepatitis B (HBsAg and / or HBcAb positive, except for those with positive surface antibody alone) or hepatitis C serological markers;
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  • HIV positive or Treponema pallidum positive patients.
  • Patients with uncontrollable active or life-threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours before infusion);
  • Patients with unstable angina and / or myocardial infarction within 6 months before screening, or patients with serious or uncontrollable other diseases (such as unstable or uncompensated respiratory, heart, liver or kidney diseases) during 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.
  • Patients with uncontrolled arrhythmia.
  • Patients on oral anticoagulation therapy within 1 week prior to BZ019 infusion.
  • Patients with active neurological auto immune or inflammatory disorders(e.g. Guillain Barre Syndrome, Amyptrophic Lateral Sclerosis)
  • Other conditions, such as compliance, that the investigators consider should not be included in this clinical trial.

Trial locations and contacts

1 site in 1 country.

Zhang Yan, Ph. D contact

021-67091122

1r1-7v5o4ef29a@dingtalk.com

Liang Lijuan, Bachelor contact

021-67091022

lianglijuan3710@dingtalk.com

China1 site, 1 recruiting

  • Shanghai Mengchao Cancer Hospital

    Shanghai, Shanghai Municipality, 201805

    Liang Lijuan, Bachelor, 15618723710, lianglijuan3710@dingtalk.com

    Recruiting

Other trials in China

About this study

Official title: A Phase II Clinical Study of CD19-targeted Chimeric Antigen Receptor (CAR) T Cells Injection, for Relapsed and Refractory (R/R) Large B-cell Lymphoma

This is a single arm,open-label, non-randomized phase 2 study to determine the efficacy of BZ019 in relapsed or refractory CD19+ B-cell Lymphoma subjects.

Being tested
BZ019

What participants receive

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

  • BZ019Biological

    A treatment program will include lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by single-dose of BZ019 administered intravenously (IV).

Study groups in NCT05472610
Study groupRoleWhat they receive
BZ019ExperimentalThe subjects are enrolled into single-dose(1～5x10^6/kg) of BZ019 ( non viral vector CD19-targeted Chimeric Antigen Receptor (CAR) T Cells Injection).
Receives: Biological: BZ019

What is being measured

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

  1. Objective response rate (ORR)

    Clinical response will be assessed by RECIST 1.1.

    Measured: Month 3

Secondary outcomes (3)

  1. Pharmacokinetics (PK)

    Peak Plasma Concentration (Cmax)

    Measured: Month 12

  2. Pharmacodynamics (PD)

    PD of IL-2, IL-4, IL-6,IL-10, IL-15, IFN-γ, TNF-α will be analysed after CAR T cell infusion

    Measured: Month 12

  3. Quality of life（QOL）

    Quality of life will be assessed by EQ-5D health Index scale

    Measured: Month 12

Timeline

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

  1. First posted25 Jul 2022
  2. Study start4 Jun 2021
  3. Primary completionJan 2023 (estimated)
  4. Study completionJan 2023 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05472610
Sponsor's protocol ID
BZ019R-A-01
Status last verified
Jul 2022
First submitted
21 Jul 2022
Last updated
25 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang Y, Lin Z, Zhang F, Chen X, Yang Y, Fu X, Li Z, Sun Y, Qian Q. Rapid response in relapsed follicular lymphoma with massive chylous ascites to anti-CD19 CAR T therapy using Piggy Bac: A case report. Front Immunol. 2022 Dec 1;13:1007210. doi: 10.3389/fimmu.2022.1007210. eCollection 2022.

    PubMed 36532014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BZ019 in people with Large B-cell Lymphoma, run by Shanghai Mengchao Cancer Hospital 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 21 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 25 Jul 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Zhang Yan, Ph. D (021-67091122, 1r1-7v5o4ef29a@dingtalk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Month 3). 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 NCT05472610, which also lists 1 linked publication.

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 25 Jul 2022.

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