Actively Recruiting
DALY II USA/ MB-CART2019.1 for DLBCL
Led by Miltenyi Biomedicine GmbH · Updated on 2025-04-24
248
Participants Needed
25
Research Sites
396 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
DALY II USA 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. Additional cohorts include subjects with B-cell primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL), mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy.
CONDITIONS
Official Title
DALY II USA/ MB-CART2019.1 for DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed B-cell non-Hodgkin's lymphoma including DLBCL or associated subtypes defined by WHO 2016
- Relapsed or refractory disease after at least two lines of chemotherapy including rituximab and anthracycline
- For CNS cohort: relapsed/refractory primary or secondary CNS lymphoma after prior therapy
- For mantle cell lymphoma cohort: relapsed/refractory disease after at least one prior systemic treatment including rituximab-based chemotherapy and BTK inhibitor
- For Richter's transformation cohort: relapsed/refractory disease after at least one prior systemic treatment
- ECOG performance status 0 or 1 (2 allowed if due to lymphoma)
- Measurable disease by Lugano 2014 or IPCG criteria
- Availability of tumor biopsy sample from most recent relapse
- No contraindications to MRI evaluation
- Adequate kidney, liver, cardiac, and blood function
- Estimated life expectancy over 3 months excluding lymphoma
You will not qualify if you...
- Primary CNS lymphoma (except for CNS cohort)
- Richter's transformed DLBCL from CLL (except for RT cohort)
- Unable to provide informed consent
- Known HIV infection or active hepatitis B or C infection without undetectable viral load
- Uncontrolled seizures or autoimmune CNS diseases
- CNS disorders impairing neurotoxicity evaluation
- Recent whole brain radiotherapy within 3 months
- Active systemic infections
- Pregnant or breastfeeding women
- Other active or recent malignancies except certain treated skin, cervical, breast, or prostate cancers in remission
- Severe immunocompromise or need for high dose corticosteroids
- Recent significant cardiac events within 6 months
- Concurrent radiotherapy or systemic therapy within specified washout periods
- Dementia interfering with therapy or monitoring
- History of severe allergic reactions 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 therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
H
Harshita Gahankari
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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