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DLBCL - Diffuse Large B Cell LymphomaPhase 2DALY II JapanNCT07288879

DALY II Japan/MB-CART2019.1 for DLBCL

A Phase 2 study testing MB-CART2019.1 in people with DLBCL - Diffuse Large B Cell Lymphoma and CAR T Cell Therapy, run by Miltenyi Biomedicine GmbH at 5 sites in Japan.

Recruiting

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

Sites and contacts
Official record
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Trial summary

DALY II Japan is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and/or refractory diffuse large B cell lymphoma (DLBCL) after receiving at least two lines of therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MB-CART2019.1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
5 sitesJapan
Study dates
11 Dec 2025to 31 Dec 2028
Phase
Phase 2
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

  • Histologically confirmed DLBCL or associated subtype, defined by WHO 2016 classification:
  • DLBCL not otherwise specified (NOS)
  • High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
  • High-grade B-cell lymphoma, NOS
  • Primary mediastinal (thymic) large B-cell lymphoma
  • Transformed lymphoma (e.g. transformed follicular or marginal zone lymphoma, follicular lymphoma Grade 3B)
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  • Relapsed or refractory disease after 2 or more lines of chemotherapy including rituximab and anthracycline and either having failed autologous stem cell transplant (ASCT), or being ineligible for or not consenting to ASCT 2.1 Chemotherapy-refractory disease is defined as one of the following:
  • No response to last line of therapy:
  • Progressive disease (PD) as best response to most recent therapy regimen
  • Stable disease (SD) as best response to most recent therapy with duration no longer than 6 months from last dose of therapy OR
  • Relapsed or persistent disease after prior ASCT for lymphoma
  • Disease progression or relapse less than or equal to 24 months of ASCT
  • If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy 2.2 Disease relapse in subjects without prior ASCT is defined as relapse of disease in ≤ 12 months after the last dose of most recent therapy regimen 2.3 Ineligible for ASCT is defined as meeting one of the following criteria:
  • Chemotherapy-refractory disease after salvage therapy
  • Disease progression or relapse ≤ 12 months after salvage therapy
  • Intolerance to salvage therapy
  • In addition, all subjects must have:
  • Age ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening. ECOG performance status of 2 at screen is allowed if the decrease in performance status is due to DLBCL
  • Measurable disease according to Lugano 2014 criteria for assessing fluorodeoxyglucose-positron emission tomography (FDG-PET)/computer tomography (CT) in lymphoma (Cheson et al, 2014)
  • CD19 or CD20 antigen expression on tumor is not required after the most recent chemoimmunotherapy; however, 6.1 Subject must have at least 20 unstained slides of tissue available prior to MB-CART2019.1 infusion 6.2 If archival tissue is not available, subject must be willing to undergo attempted repeat biopsy
  • No clinical suspicion of central nervous system (CNS) lymphoma
  • If the subject has history of CNS disease, then he/she must 8.1. Have no signs or symptoms of CNS disease 8.2. Have no active disease on magnetic resonance imaging (MRI) 8.3. Have no large cell lymphoma present in cerebral spinal fluid (CSF) on cytospin preparation and flow cytometry, regardless of the number of white blood cells (WBCs)
  • If the subject has history of cerebral vascular accident (CVA) 9.1. The CVA event must be greater than 12 months prior to leukapheresis 9.2. Any neurological deficits must be stable
  • An estimated creatinine clearance by Cockcroft-Gault Equation (eGFR) > 60mL/min
  • Cardiac ejection fraction (EF) ≥ 45% as determined by an echocardiogram (ECHO)
  • Resting O2 saturation >90% on room air
  • Serum alanine aminotransferase (ALT) / aspartate aminotransferase (AST) <5 times the Upper Limit of Normal (ULN) for age
  • Total bilirubin <1.5 mg/dl, except in individuals with Gilbert's syndrome
  • Absolute neutrophil count (ANC) > 1000/μL
  • Absolute lymphocyte count > 100/μL
  • Platelet count > 50,000/μL
  • Estimated life expectancy of more than 3 months other than primary disease
  • Subjects of childbearing or child fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up period of the study

Who cannot join

  • Primary CNS lymphoma
  • Richter's transformed DLBCL arising from chronic lymphocytic leukemia (CLL)
  • Unable to give informed consent
  • Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B (HBsAg positive), unless confirmed to be polymerase chain reaction (PCR) negative; antiviral prophylaxis is required as recommended in the Japanese guidelines for Hepatitis B treatment if HBsAg negative and anti-HBc positive
  • Known history of infection with hepatitis C virus (anti-HCV positive) unless viral load is undetectable per quantitative PCR and/or nucleic acid testing
  • Known history of active seizure or presence of seizure activities or on active anti-seizure medications within the prior 12 months
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  • Known history of CVA within prior 12 months
  • Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease
  • Presence of active CNS disorder that, in the judgment of the investigator, may impair the ability to evaluate neurotoxicity
  • Active systemic fungal, viral or bacterial infection
  • Pregnant or breast-feeding woman
  • 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 2 years prior to the study
  • Adequately treated breast or prostate carcinoma on hormonal therapies such as Lupron or tamoxifen and in clinical remission of ≥ 2 years
  • A primary malignancy which has been completely resected / treated with curative intent and in complete remission of ≥ 2 years
  • History of non-neurologic autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) requiring systemic immunosuppressive or systemic disease modifying agents within the last 2 years
  • Medical condition requiring prolonged use of systemic corticosteroids equivalent to Prednisone >10 mg/day
  • History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment
  • Concurrent radiotherapy (allow up to time of leukapheresis)
  • Baseline dementia that would interfere with therapy or monitoring, determined using Immune Effector Cell-Associated Encephalopathy (ICE) Assessment at baseline. (Appendix 6, Section 13.6)
  • History of severe immediate hypersensitivity reaction to any of the agents used in this study
  • Refusal to participate in additional lentiviral gene therapy LTFU protocol
  • Prior CAR T cell therapy for any indication
  • Prior allogeneic stem cell transplant for any indication.
  • Prior bispecific antibodies for cancer therapy
  • Prior T cell receptor-engineered T cell therapy
  • Prior anti CD 19 immunotherapy
  • Hypersensitivity against any drug including MB-CART2019.1 (and the constituents used in the production, ingredients/impurities, including bovine and rodent-derived components), that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory preparative chemotherapy or rescue medication/salvage therapies for treatment related toxicities.

Trial locations and contacts

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

Clinical Trial Manager contact

+4922048306820

clinicaltrials.gov@miltenyi.com

5 sites in 1 country

Japan5 sites, 5 recruiting

  • National Cancer Center Hospital

    Tokyo, 104-0045

    Recruiting

  • Toranomon Hospital

    Tokyo, 105-8470

    Not yet recruiting

  • Juntendo University Hospital

    Tokyo, 113-8431

    Not yet recruiting

  • Tokyo Metropolitan Komagome Hospital

    Tokyo, 113-8677

    Recruiting

  • Keio University Hospital

    Tokyo, 160-8582

    Not yet recruiting

Other trials in Japan

About this study

Official title: A Multi-center Single Arm Phase II Study to Evaluate the Safety and Efficacy of Genetically Engineered Autologous Cells Expressing Anti-CD20 and Anti-CD19 Specific Chimeric Antigen Receptor in Subjects With Relapsed and/or Refractory Diffuse Large B Cell Lymphoma.

DALY II Japan is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and/or refractory diffuse large B cell lymphoma (DLBCL) after receiving at least two lines of therapy.

Read the detailed description

A prospective, single arm, open label, multi-center, phase II study of autologous T cells engineered against both CD19 and CD20 antigens for subjects with relapsed or refractory DLBCL after receiving at least two lines of therapy. The investigational agent is the MB-CART2019.1 cells. After successful screening, subjects will undergo leukapheresis to collect product for manufacturing. In preparation for the fresh product infusion, subjects will undergo a lymphodepleting regimen with cyclophosphamide and fludarabine. Cell infusion will be administered intravenously at a dose of 2.5 x 10^6 CAR+ cells/kg body weight. Subjects will be followed for up to 2 years, for efficacy and safety outcomes as well as health-related quality of life (HRQoL). Additional long-term follow-up will be conducted for participants under a separate long-term follow-up protocol.

Being tested
MB-CART2019.1
Keywords
CAR T Cell therapy, DLBCL
Medical subject headings
Dendritic Cell Sarcoma, Interdigitating

What participants receive

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

  • MB-CART2019.1Biological

    CAR T cell therapy

Study groups in NCT07288879
Study groupRoleWhat they receive
MB-CART2019.1 in DLBCLExperimentalMB-CART2019.1 Treatment
Receives: Biological: MB-CART2019.1

What is being measured

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

  1. Objective Response Rate

    Objective Response Rate (ORR) (complete response rate [CRR] + partial response rate [PRR]) using Lugano 2014 Criteria (Cheson et al, 2014) at one month with independent central review

    Measured: 1 month

Secondary outcomes (13)

  1. Complete Response Rate

    Complete response rate using Lugano 2014 Criteria (Cheson et al, 2014) at 6 months.

    Measured: 6 months

  2. Duration of response

    Duration of response (DOR)

    Measured: up to 2 years

  3. Objective Response Rate

    ORR using Lugano 2014 criteria (Cheson et al, 2014) at 6 months.

    Measured: 6 months

  4. Best Overall Response

    Best overall response (BOR)

    Measured: 2 years

  5. Progression Free Survival

    Progression Free Survival

    Measured: up to 2 years

  6. Overall Survival

    Overall Survival

    Measured: up to 2 years

  7. Type, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI)

    Type, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI)

    Measured: up to 2 years

  8. Incidence of anti-MB-CART2019.1 antibodies

    Incidence of anti-MB-CART2019.1 antibodies

    Measured: up to 2 years

  9. Persistence of MB-CART2019.1

    Persistence of MB-CART2019.1

    Measured: up to 2 years

  10. Cytokine levels

    Measure and correlate the types and level of cytokines in subjects following MB-CART2019.1 infusion with severity of CRS, ICANS and efficacy.

    Measured: up to 2 years

  11. CD19 and CD20 antigen expression

    Correlate the changes in tumor CD19 and CD20 antigen expression with disease progression and relapse

    Measured: up to 2 years

  12. Quality of Life /Patient-Reported Outcome assessments: EQ-5D-5L Health-Related Quality of Life Index Score

    Measured using the EQ-5D-5L instrument. The index score reflects health utility (range -0.281 to 1.000), where higher scores indicate better self-reported health status.

    Measured: Baseline, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24

  13. Quality of Life /Patient-Reported Outcome assessments: Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score

    The FACT-Lym is a patient-reported outcome instrument designed to assess health-related quality of life in patients with lymphoma. The total score is derived from the FACT-General core questionnaire (physical, social/family, emotional, and functional well-being) and a lymphoma-specific subscale. Higher scores indicate better health-related quality of life.

    Measured: Baseline, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24

Timeline

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

  1. First posted17 Dec 2025
  2. Study start11 Dec 2025
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Dec 2028 (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
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07288879
Sponsor's protocol ID
M-2023-413
Other IDs
jRCT2033250384
Acronym
DALY II Japan
Status last verified
Jan 2026
First submitted
20 Nov 2025
Last updated
8 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MB-CART2019.1 in people with DLBCL - Diffuse Large B Cell Lymphoma and CAR T Cell Therapy, run by Miltenyi Biomedicine GmbH at 5 sites in Japan.

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 34 inclusion and 29 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 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. 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?

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 Clinical Trial Manager (+4922048306820, clinicaltrials.gov@miltenyi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: 1 month). 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 NCT07288879.

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 8 Jan 2026.

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