Actively Recruiting
A Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma (CNSL)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-21
12
Participants Needed
7
Research Sites
154 weeks
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
This study will test whether MB-CART19.1 is a safe and effective treatment for central nervous system lymphoma (CNSL). This study will test different doses of MB-CART19.1 to find the highest dose that causes few or mild side effects in participants.
CONDITIONS
Official 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 who are at least 18 years of age on the day of consenting to the study.
- Histologically documented primary or secondary central nervous system lymphoma of DLBCL subtype.
- Relapsed or refractory primary or secondary CNSL patients who have received at least one prior CNS-directed methotrexate-based therapy.
- For relapsed patients, parenchymal lesions must show disease progression on imaging within 21 days of study consent.
- For refractory patients, residual disease must be present after their last therapy.
- For leptomeningeal disease only, cerebrospinal fluid findings or imaging must confirm lymphoma involvement within 21 days of registration.
- Creatinine clearance ≥ 40 ml/min/m2, direct bilirubin ≤ 2.0 mg/100 ml, AST and ALT ≤ 3.0x upper limit of normal.
- Adequate pulmonary function with oxygen saturation ≥ 90% on room air.
- Ability to tolerate MRI and CT scans.
- Ability to tolerate lumbar puncture and/or Ommaya taps.
- Must be off corticosteroids or on a stable or decreasing dose of dexamethasone ≤ 2 mg daily for 7 days before apheresis and 72 hours before CAR T cell infusion.
You will not qualify if you...
- ECOG performance status greater than 2 (status of 2 may be enrolled at investigator discretion).
- Active systemic lymphoma outside the CNS.
- Absence of CD19 expression in recent cerebrospinal fluid or brain tissue sample.
- Any single CNS lymphoma lesion larger than 3 cm in eloquent brain areas.
- Prior treatment of systemic lymphoma with CD19-targeted CAR T cells.
- Pregnancy or lactation; patients of childbearing potential must use effective contraception during and for 1 year after treatment.
- Impaired cardiac function with left ventricular ejection fraction below 40% within the last year.
- Autoimmune disease requiring systemic T cell-suppressive therapy.
- Severe cardiac conditions including NYHA stage III or IV heart failure, recent myocardial infarction within 6 months, or significant ventricular arrhythmia or unexplained syncope within 6 months.
- Ocular lymphoma without other CNS involvement.
- Recent chemotherapy, monoclonal antibodies, targeted therapy, or hematopoietic stem cell transplant within specified timeframes, or unresolved side effects.
- HIV infection.
- Active hepatitis B or C infection.
- Uncontrolled systemic infections at leukapheresis or CAR T cell infusion.
- Concurrent active malignancies requiring treatment other than observation or hormonal therapy, except for certain skin cancers.
- Exposure to immune checkpoint inhibitors within 8 weeks.
- Use of herbal supplements during the study.
- Any other condition deemed by the physician to make the patient ineligible.
AI-Screening
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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
CONTACT
M
Maria Palomba, MD
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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