Actively Recruiting
DALY II Japan/MB-CART2019.1 for DLBCL
Led by Miltenyi Biomedicine GmbH · Updated on 2026-01-08
31
Participants Needed
5
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
DALY II Japan/MB-CART2019.1 for DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed DLBCL or associated subtype as defined by WHO 2016 classification
- Relapsed or refractory disease after 2 or more lines of chemotherapy including rituximab and anthracycline
- Failed autologous stem cell transplant (ASCT), or ineligible for or declined ASCT
- Chemotherapy-refractory disease or disease relapse within specified timeframes after prior therapies
- Age 18 years or older
- ECOG performance status of 0 or 1 at screening; status 2 allowed if due to DLBCL
- Measurable disease by Lugano 2014 criteria using FDG-PET/CT
- Availability of at least 20 unstained tissue slides or willingness to have repeat biopsy
- No clinical suspicion of CNS lymphoma
- No active CNS disease if history of CNS involvement, confirmed by MRI and CSF tests
- If history of cerebral vascular accident, event must be >12 months before leukapheresis and neurological deficits stable
- Estimated creatinine clearance >60 mL/min
- Cardiac ejection fraction ≥45% by echocardiogram
- Resting oxygen saturation >90% on room air
- Liver enzymes (ALT/AST) less than 5 times upper limit of normal
- Total bilirubin less than 1.5 mg/dL (except Gilbert's syndrome)
- Absolute neutrophil count >1000/µL
- Absolute lymphocyte count >100/µL
- Platelet count >50,000/µL
- Estimated life expectancy over 3 months not related to lymphoma
- Willingness to use birth control during study and follow-up if of childbearing potential
You will not qualify if you...
- Primary central nervous system lymphoma
- Richter's transformed DLBCL from chronic lymphocytic leukemia
- Unable to provide informed consent
- Known HIV infection or active hepatitis B or C unless viral load undetectable and appropriate prophylaxis
- History of seizures or active seizure activity within past 12 months
- History of cerebral vascular accident within past 12 months
- Autoimmune CNS diseases or active CNS disorders affecting neurotoxicity evaluation
- Active systemic infections (fungal, viral, bacterial)
- Pregnant or breastfeeding women
- Recent or concurrent malignancies except certain treated cancers in remission
- Autoimmune diseases requiring recent immunosuppressive therapy
- Medical conditions requiring prolonged high-dose corticosteroids
- Significant cardiac disease or events within past 6 months
- Concurrent radiotherapy up to leukapheresis
- Baseline dementia interfering with monitoring
- Severe hypersensitivity to study agents or related substances
- Refusal to participate in long-term gene therapy follow-up
- Prior CAR T cell therapy, allogeneic stem cell transplant, bispecific antibodies, T cell receptor therapies, or anti-CD19 immunotherapy
- Hypersensitivity to MB-CART2019.1 or related substances used in treatment or supportive care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Actively Recruiting
2
Toranomon Hospital
Tokyo, Japan, 105-8470
Not Yet Recruiting
3
Juntendo University Hospital
Tokyo, Japan, 113-8431
Not Yet Recruiting
4
Tokyo Metropolitan Komagome Hospital
Tokyo, Japan, 113-8677
Actively Recruiting
5
Keio University Hospital
Tokyo, Japan, 160-8582
Not Yet Recruiting
Research Team
C
Clinical Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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