Actively Recruiting
A Phase I Study of MB-CART19.1 Cellular Therapy for Relapsed or Refractory Primary and Secondary Central Nervous System Lymphoma Using On-Site Manufacturing with the CliniMACS Prodigy Device
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-06-05
12
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
M
Miltenyi Biomedicine GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating MB-CART19.1 cellular therapy as a treatment for central nervous system lymphoma (CNSL), including both primary and secondary types. This phase I study aims to determine the highest dose of MB-CART19.1 that causes only mild or few side effects, focusing on safety and effectiveness in patients with relapsed or refractory CNSL. Participants will undergo a process called leukapheresis to collect specific immune cells from their blood. These cells are then modified in the laboratory using a lentiviral vector to target CD19, a marker on lymphoma cells. The modified T cells are expanded and infused back into the patient 2 to 7 days after chemotherapy that prepares the body. The infusion may be fresh or frozen based on standard procedures. After treatment, blood and cerebrospinal fluid samples will be collected to monitor treatment effects, toxicity, and the survival of the modified cells. During the study, participants will have regular assessments including imaging scans such as MRI or CT to check disease status, blood tests to evaluate organ function, and cerebrospinal fluid analysis. Researchers will monitor safety by tracking side effects and will measure the maximum tolerated dose over one year. The entire study period covers treatment administration and follow-up to understand how well the therapy works and its safety profile.
CONDITIONS
Brief Title
A Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma (CNSL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older at the time of consenting
- Histologically confirmed primary or secondary central nervous system lymphoma of DLBCL subtype
- Relapsed or refractory CNSL after at least one prior CNS-directed methotrexate-based therapy
- Evidence of disease progression on brain MRI or head CT within 21 days for relapsed patients
- Residual disease after last therapy for refractory patients
- CSF involvement confirmed by cytology, flow cytometry, or imaging for leptomeningeal disease within 21 days
- Adequate kidney function (creatinine clearance 6 ml/min/m2), liver function (bilirubin 4 mg/100 ml, AST and ALT 4.5 x ULN)
- Adequate lung function with oxygen saturation 9% on room air
- Ability to tolerate MRI, CT scans, lumbar puncture, and/or Ommaya taps
- Stable or decreasing corticosteroid dose 2 mg dexamethasone equivalent daily for 7 days before apheresis and 72 hours before infusion
You will not qualify if you...
- ECOG performance status greater than 2 (status 2 may be enrolled at investigator discretion)
- Active systemic lymphoma outside the CNS
- Absence of CD19 expression in recent CSF or brain tissue samples
- Any single CNS lymphoma lesion larger than 3 cm in eloquent brain areas
- Prior systemic lymphoma treatment with CD19-targeted CAR T cells
- Pregnancy or lactation; effective contraception required for childbearing patients during and 1 year after treatment
- Impaired cardiac function (LVEF less than 40%) in last year
- Autoimmune diseases needing systemic T cell-suppressive therapy
- Severe cardiac conditions such as NYHA stage III/IV heart failure, recent myocardial infarction within 6 months, or serious ventricular arrhythmias
- Ocular lymphoma without other CNS involvement
- Recent chemotherapy, antibodies, targeted therapy, or stem cell transplantation within defined time frames
- HIV infection
- Active hepatitis B or C infection
- Uncontrolled infections at time of leukapheresis or infusion
- Other active malignancies requiring therapy except certain skin cancers
- Exposure to immune checkpoint inhibitors within 8 weeks
- Use of herbal supplements during the study
- Any other condition making the patient unsuitable as judged by physician or principal investigator
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.
Duration - Variable time including cell processing and conditioning chemotherapy, with infusion 2-7 days after chemotherapy
Participants undergo leukapheresis to collect mononuclear cells, followed by processing and genetic modification of T cells. After conditioning chemotherapy, a single infusion of MB-CART19.1 cellular therapy is administered during an inpatient admission.
1 inpatient infusion visit and multiple blood and cerebrospinal fluid sampling visits following treatment
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
I
Ivan Kotchetkov, MD
M
Maria Palomba, MD
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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