Actively Recruiting
Phase II Multi-center Study of Genetically Engineered Autologous CAR T Cells Targeting CD19 and CD20 in Relapsed or Refractory Diffuse Large B Cell Lymphoma
Led by Miltenyi Biomedicine GmbH · Updated on 2025-04-24
248
Participants Needed
25
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating zamtocabtagene autoleucel (MB-CART2019.1), a genetically engineered autologous T cell therapy targeting CD19 and CD20 antigens, in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who have received at least two prior treatments. The study also includes groups with primary or secondary central nervous system lymphoma, mantle cell lymphoma, and Richter's transformation after at least one prior therapy. This is a phase II, multi-center, single-arm, open-label trial assessing efficacy, safety, and pharmacokinetics. Participants undergo leukapheresis to collect their T cells, which are then engineered to create the MB-CART2019.1 product. Before receiving the cell infusion, patients have a lymphodepleting chemotherapy regimen with cyclophosphamide and fludarabine or bendamustine. The engineered cells are infused intravenously at a dose based on body weight. The study begins with a safety evaluation in three subjects before enrolling additional participants. During the study, participants are monitored for up to two years to assess treatment response, safety, and quality of life using various clinical and laboratory tests, including imaging and biopsies. Researchers will measure overall response rate as the primary outcome and several secondary outcomes such as progression-free survival, overall survival, adverse events, immune response, and patient-reported outcomes. Longer-term follow-up is conducted separately to monitor ongoing effects.
CONDITIONS
Brief Title
DALY II USA/ MB-CART2019.1 for DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed B-cell non-Hodgkin's lymphoma, including DLBCL or related subtypes as defined by WHO 2016 classification
- For CNS lymphoma cohort: primary or secondary CNS lymphoma
- Mantle Cell Lymphoma cohort confirmed by cyclin D1 overexpression or t(11;14) translocation
- Richter's Transformation cohort with histologically confirmed disease
- Relapsed or refractory disease after at least two prior lines of therapy for DLBCL and associated subtypes, or at least one line for other cohorts
- ECOG performance status 0 or 1, or 2 if due to lymphoma
- Measurable disease by established lymphoma criteria
- Tumor biopsy sample available from most recent relapse
- No clinical suspicion or active CNS lymphoma (except CNS cohort)
- Stable neurological status if history of cerebral vascular accident over 12 months ago
- Adequate kidney, liver, heart, and blood function as specified
- Life expectancy over 3 months other than primary disease
- Age 18 years or older
You will not qualify if you...
- Primary CNS lymphoma (except CNS cohort)
- Richter's transformed DLBCL from chronic lymphocytic leukemia (except RT cohort)
- Unable to give informed consent
- Known HIV infection or active hepatitis B or C infection
- Uncontrolled seizures or autoimmune CNS disease
- CNS conditions impairing neurotoxicity evaluation
- Recent whole brain radiotherapy (within 3 months)
- Active systemic infections
- Pregnant or breastfeeding women
- Recent or concurrent malignancies except certain treated cancers in remission
- Severely immunocompromised status or ongoing high-dose corticosteroids
- Significant recent cardiac events or disease
- Concurrent radiotherapy or recent systemic therapy within specified timeframes
- Baseline dementia affecting therapy or monitoring
- History of severe hypersensitivity to study agents
- Refusal to participate in long-term follow-up
- Prior CAR-T or systemic gene therapy for B-cell lymphoma
- Prior allogeneic stem cell transplant
- Prior bispecific T-cell engager (BITE) antibodies or T cell receptor-engineered therapy for cancer treatment
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)
Duration - Approximately 1 to 2 weeks from leukapheresis to cell infusion
Participants undergo leukapheresis to collect cells for manufacturing. They then receive a lymphodepleting chemotherapy regimen followed by infusion of genetically engineered CAR T cells targeting CD19 and CD20.
Multiple visits including leukapheresis, chemotherapy administration, and cell infusion
Duration - Up to 2 years
Participants are followed for up to 2 years after treatment to monitor efficacy, safety, and quality of life.
Regular visits over 2 years for assessments and monitoring
Trial Site Locations
Total: 25 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
UC San Diego Health
La Jolla, California, United States, 92037
Actively Recruiting
4
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
5
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
6
Baptist Health Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
7
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
9
Robert H Lurie Cancer Center
Chicago, Illinois, United States, 60611
Actively Recruiting
10
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
11
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
12
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
13
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
14
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
15
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Terminated
16
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
17
Duke University Medical Center - Division of Hematologic Malignancies
Durham, North Carolina, United States, 27705
Actively Recruiting
18
The Ohio State University Wexner Medical Center James Cancer
Columbus, Ohio, United States, 43210
Actively Recruiting
19
Oregon Health and Science University Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
20
Allegheny Health Network Cancer Institute
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
21
University of Pittsburgh - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15260
Withdrawn
22
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
23
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
24
University of Alberta Cross Cancer Institute
Edmonton, Alberta, Canada, AB T6G 1Z2
Actively Recruiting
25
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, ON M5G 2C4
Actively Recruiting
Research Team
B
Bryan Dumont
H
Harshita Gahankari
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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