DALY II Japan/MB-CART2019.1 for DLBCL

NCT07288879 | Recruiting Phase 2

• 2 other identifiers: M-2023-413jRCT2033250384
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

CAR T Cell Therapy; DLBCL - Diffuse Large B Cell Lymphoma

Keywords

CAR T Cell therapy; DLBCL

Outcome Measures

Primary Outcomes (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

  1 month

Secondary Outcomes (13)

• Complete Response Rate

  6 months

• Duration of response

  up to 2 years

• Objective Response Rate

  6 months

• Best Overall Response

  2 years

• Progression Free Survival

  up to 2 years

Study Arms (1)

MB-CART2019.1 in DLBCL

EXPERIMENTAL

MB-CART2019.1 Treatment

Biological: MB-CART2019.1

Interventions

MB-CART2019.1 BIOLOGICAL

CAR T cell therapy

MB-CART2019.1 in DLBCL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Miltenyi Biomedicine GmbH: lead

Study Sites (5)

National Cancer Center Hospital

Tokyo, 104-0045, Japan

RECRUITING

Toranomon Hospital

Tokyo, 105-8470, Japan

NOT YET RECRUITING

Juntendo University Hospital

Tokyo, 113-8431, Japan

NOT YET RECRUITING

Tokyo Metropolitan Komagome Hospital

Tokyo, 113-8677, Japan

RECRUITING

Keio University Hospital

Tokyo, 160-8582, Japan

NOT YET RECRUITING

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Clinical Trial Manager

CONTACT

+4922048306820; clinicaltrials.gov@miltenyi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 17, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5)