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Non-Hodgkin Lymphoma, B-cellEarly Phase 1NCT06446128

A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)

A Early Phase 1 study testing CD19/CD20/BCMA CAR T cells in people with Non-Hodgkin Lymphoma, B-cell, run by Shanghai Cell Therapy Group Co.,Ltd at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed or refractory B cell non-Hodgkin lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin Lymphoma, B-cell
What is being tested?
CD19/CD20/BCMA CAR T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
7 May 2024to 31 Dec 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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

  • Patients who are diagnosed with relapsed/refractory B cell non-Hodgkin lymphoma , especially
  • Diffuse Large B Cell Lymphoma, not other specified (DLBCL,NOS),
  • Primary Mediastinal Large B Cell Lymphoma (PMBCL)
  • Transformation Follicular Lymphoma (TFL)
  • High grade B-cell lymphoma(HGBCL)
  • High grade B-cell lymphoma (HGBCL) with MYC(myelocytomatosis oncogene) and BCL2(B-cell lymphoma2) /BCL6 (B-cell lymphoma6) rearrangement
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  • Refractory diseases are defined as one of the following
  • No response to last line of therapy: i. Progressive disease (PD) as best response to most recent therapy regimen; ii. Stable disease (SD) as best response to most recent therapy regimen
  • Not candidate for autologous stem cell transplant (ASCT) or refractory post-ASCT: i. Disease progression (PD) or relapsed ≤12 months of ASCT (must have biopsy proven recurrence in relapsed individuals) ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy
  • Individuals must have received adequate prior therapy including at a minimum:
  • anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative and
  • an anthracycline containing chemotherapy regimen
  • Immunohistochemical staining shows at least two of B cell surface receptor antigen CD19,CD20, BCMA are positive(including weak, medium and strong positive)
  • At least one measurable lesion during the screening based on the recommendation for initial evaluation, staging and response assessment of Hodgkin and non-Hodgkin lymphoma.
  • Life expectancy ≥ 12 weeks
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  • Adequate renal, hepatic, pulmonary and cardiac function defined as:
  • Renal function: Serum creatinine ≤ 1.5 upper limit of normal(ULN), or eGFR ≥ 60 mL/min/1.73m2 [eGFR(estimated glomerular filtration rate)=186×age^-0.203×SCr^-1.154（mg/dl）,female×0.742]
  • Hepatic function: i: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 ULN and ii: total bilirubin ≤ 2 ULN, except in individuals with Gilbert syndrome (in Gilbert's syndrome patients, those with total bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN can be enrolled).iii: International normalized ratio (INR) or prothrombin time (PT) ≤1.5 ULN Pulmonary: Have the minimum level of pulmonary reserve, defined as ≤ CTCAE (Common Terminology Criteria for Adverse Events) grade 1 dyspnea and the SaO2(oxygen saturation)≥ 91% on room air
  • Cardiac: left ventricular ejection fraction (LVEF) ≥50% determined by echocardiogram(ECG) or multigated acquisition scan (MUGA)
  • Adequate bone marrow function, define as:
  • absolute neutrophil count (ANC) ≥1 ×10^9/L
  • absolute lymphocyte count (ALC)≥ 0.5 ×10^9/L
  • Platelets ≥50 ×109/L；
  • Hemoglobulin ≥80 g/L; patients with bone marrow involvement can be enrolled if globulin>60 g/L
  • Female of child-bearing age and male participants must agree to use effective contraceptive methods until no CAR-T cells can be detected by PCR(polymerase chain reaction) test.

Who cannot join

  • Individuals who have antiCD45 or antiCD3 therapy
  • Individuals with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of primary or secondary CNS (central nervous system) lymphoma, cerebrospinal fluid malignant cells or brain metastases
  • Presence or history of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
  • History of allogeneic stem cell transplantation
  • Any of the following situations:
  • HBsAg/ HBeAg positive; HBeAb/HBcAb positive and HBV(hepatitis B virus) DNA copies above the lower test limit;
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  • HCV(hepatitis C virus) RNA positive
  • HIV(human immunodeficiency virus) positive or treponema pallidum positive
  • Presence of active or life-threatening fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
  • Individuals presence of unstable angina or myocardial infarction within 6 months of screening, or other severe/uncontrolled diseases during the screening (eg. Unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
  • Presence of uncontrolled arrhythmia with treatment
  • Pregnancy or breastfeeding women
  • Other protocol defined inclusion/exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jinxing Lou contact

021-67091399

loujx@shcell.com

China1 site, 1 recruiting

  • Mengchao Cancer Hospital

    Shanghai, Shanghai Municipality, 201800

    Jinxing Lou, 18911335396, loujx@shcell.com

    Jinxing Lou

    Recruiting

Other trials in China

About this study

Official title: A Dose Escalating Study of CD19/CD22/BCMA Three Targets Autologous Chimeric Antigen Receptor T (CAR-T) Cell Therapy in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed or refractory B cell non-Hodgkin lymphoma.

Read the detailed description

This is a single arm, open-label, dose escalation investigator initiated (IIT) study, the primary objective is to evaluate the safety and tolerability of CD19/CD22/BCMA CAR-T therapy in patients with B cell non-Hodgkin lymphoma, and determine the maximum tolerated dose (MTD). For the secondary objectives, pharmacokinetics(PK), survival of CAR-T cells in vivo, pharmacodynamics (PD) and efficacy in R/R B cell NHL will be evaluated.

This study flow comprises of a screening phase( ≤28 days prior to apheresis), apheresis phase (occur upon enrollment, ≤10 days prior to infusion), lymphodepletion phase (from Day -5 to Day -3) ,infusion of CD19/CD22/BCMA CAR-T cells on Day0, DLT assessments phase from Day1 to Day 28 and post-treatment follow-up phase (Day 29 and up to end of the study).

Being tested
CD19/CD20/BCMA CAR T cells
Keywords
B cell non-hodgkin lymphoma, CAR-T, CD19, CD22, BCMA
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, B-Cell

What participants receive

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

  • CD19/CD20/BCMA CAR T cellsBiological

    Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CD19/CD20/BCMA CAR T cells.

    Cyclophosphamide and fludarabine will be given from day-5 to day-3 before the infusion for lymphodepletion. On day0 subjects will receive one dose treatment with CD19/CD20/BCMA CAR T cells by intravenous (IV) injection

Study groups in NCT06446128
Study groupRoleWhat they receive
CD19/CD20/BCMA CAR T therapyExperimentalThe safety and tolerability of BZE2204 will be assessed in a "1+1+1+3" and "3+3" dose escalation approach in different B-cell non-hodgkin lymphoma
Receives: Biological: CD19/CD20/BCMA CAR T cells

What is being measured

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

  1. Dose-limiting toxicity(DLT)

    Safety

    Measured: Day0-Day28

  2. Maximum tolerated dose (MTD)

    Tolerability

    Measured: Day0-Day28

Secondary outcomes (7)

  1. Maximum Plasma Concentration(Cmax)

    Pharmacokinetics (PK)

    Measured: Day0-Day28，Day0-undetectable for CAR positive T cells

  2. Maximum Plasma Concentration Time (Tmax)

    Pharmacokinetics (PK)

    Measured: Day0-Day28，Day0-undetectable for CAR positive T cells

  3. Area Under Curve (AUC)

    Pharmacokinetics(PK)

    Measured: Day0-Day28，Day0-undetectable for CAR positive T cells

  4. CAR positive T cells

    Pharmacokinetics(PK)

    Measured: Day0-Day28，Day0-undetectable for CAR positive T cells

  5. Cytokines ( IL(interleukin)-2, IL-4, IL-6, IL-8, IL-10, IL-15, IFN(interferon)-γ, TNF(tumor necrosis factor)-α and MCP( monocyte chemoattractant protein)-1)

    Pharmacodynamics (PD)

    Measured: Day0-Day28

  6. Overall survival (OS)

    Clinical response assessed by Lugano Response Criteria for non-Hodgkin Lymphoma

    Measured: Day28,Month2,Month3,Month6,Month9,Month12,Month18,Month24

  7. Progression-free survival (PFS)

    Clinical response assessed by Lugano Response Criteria for non-Hodgkin Lymphoma

    Measured: Day28,Month2,Month3,Month6,Month9,Month12,Month18,Month24

Timeline

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

  1. First posted6 Jun 2024
  2. Study start7 May 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06446128
Sponsor's protocol ID
BZE2204-A-01
Status last verified
Aug 2025
First submitted
16 May 2024
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CD19/CD20/BCMA CAR T cells in people with Non-Hodgkin Lymphoma, B-cell, run by Shanghai Cell Therapy Group Co.,Ltd 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 26 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 21 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 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Jinxing Lou (021-67091399, loujx@shcell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity(DLT) (time frame: Day0-Day28). The study lists 2 primary outcomes in all. 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 NCT06446128.

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 21 Aug 2025.

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