Actively Recruiting
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.
Led by Miltenyi Biomedicine GmbH · Updated on 2026-01-08
31
Participants Needed
5
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a treatment for patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who have already received at least two lines of therapy. This phase II, multi-center, single arm trial is evaluating the safety, effectiveness, and how the body processes a new therapy called MB-CART2019.1, which uses specially engineered T cells targeting CD19 and CD20 proteins on lymphoma cells. Participants will have their own immune cells collected through leukapheresis, which are then modified in the lab to target cancer cells. Before receiving the treatment, they undergo chemotherapy with cyclophosphamide and fludarabine to prepare their body. The modified cells are infused intravenously at a dose based on body weight. After treatment, participants are followed for up to two years to monitor treatment response, side effects, and quality of life. Additional long-term follow-up may occur under a separate protocol. During the study, participants will have regular assessments including scans, laboratory tests, and quality of life questionnaires. Researchers will track response to treatment at 1 month and ongoing outcomes such as survival and side effects for up to two years. They will also monitor immune responses, levels of the infused cells, and other biological markers. This comprehensive monitoring aims to provide detailed information about the therapy's impact and safety throughout the study period.
CONDITIONS
Brief Title
DALY II Japan/MB-CART2019.1 for DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diffuse large B cell lymphoma (DLBCL) or associated subtypes per WHO 2016 classification
- Relapsed or refractory disease after 2 or more chemotherapy lines including rituximab and anthracycline
- Failed autologous stem cell transplant (ASCT) or ineligible/not consenting to ASCT
- Age 18 years or older
- ECOG performance status 0 or 1 (2 allowed if due to DLBCL)
- Measurable disease by Lugano 2014 criteria on PET/CT
- Availability of at least 20 unstained tissue slides or willingness for repeat biopsy
- No clinical suspicion of central nervous system lymphoma
- If history of CNS disease, must have no active signs, symptoms, or large cell lymphoma in cerebrospinal fluid
- If history of cerebral vascular accident, event must be >12 months prior and neurological deficits stable
- Estimated creatinine clearance >60 mL/min
- Cardiac ejection fraction ≥45%
- 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)
- Adequate blood counts: ANC > 1000/µL, lymphocytes > 100/µL, platelets > 50,000/µL
- Estimated life expectancy over 3 months apart from lymphoma
- Willingness to use birth control if of childbearing or fathering potential during study and follow-up
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 unless PCR negative with prophylaxis
- Active hepatitis C infection unless undetectable viral load
- Active seizure or seizure history with medications in past 12 months
- Cerebral vascular accident within prior 12 months
- Autoimmune CNS diseases like multiple sclerosis or optic neuritis
- Active CNS disorders impairing neurotoxicity evaluation
- Active systemic fungal, viral, or bacterial infection
- Pregnant or breastfeeding women
- Recent or concurrent malignancies except certain treated cancers in remission
- Non-neurologic autoimmune diseases needing systemic immunosuppression in past 2 years
- Medical conditions requiring prolonged corticosteroids above prednisone 10 mg/day
- Recent serious cardiac events within 6 months
- Concurrent radiotherapy up to leukapheresis
- Baseline dementia interfering with therapy or monitoring
- Severe hypersensitivity to study agents or components
- Refusal of additional long-term follow-up gene therapy protocol
- Previous CAR T cell therapy, allogeneic stem cell transplant, bispecific antibodies, T cell receptor-engineered therapy, or anti-CD19 immunotherapy
- Hypersensitivity to MB-CART2019.1 or related substances used during trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to several weeks including preparation and treatment infusion
Participants undergo leukapheresis to collect cells for manufacturing, receive a lymphodepleting chemotherapy regimen, followed by a single intravenous infusion of MB-CART2019.1 cells.
1 leukapheresis visit, multiple visits for lymphodepleting chemotherapy, and 1 infusion visit
Duration - Up to 2 years
Participants are followed for up to 2 years to monitor safety, efficacy, and quality of life outcomes after treatment.
Multiple visits over 2 years for monitoring and assessments
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
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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