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A Study of MB-CART19.1 for Central Nervous System Lymphoma

This study is testing a cellular therapy called MB-CART19.1 for people with central nervous system lymphoma (CNSL). CNSL is a type of cancer that affects the brain or spinal cord. The study aims to find the highest dose of MB-CART19.1 that is safe and causes few or mild side effects. You may be able to join if you are at least 18 years old, have a specific type of CNSL (DLBCL subtype), and your lymphoma has returned or not responded to at least one prior treatment that included methotrexate. The study plans to enroll 12 participants, but its current recruitment status is unclear.

Study design
This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 12 participants to test different doses of MB-CART19.1.
What's involved
You would receive MB-CART19.1 as a single infusion during a hospital stay. Specific details about other visits or procedures are not provided.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the maximum tolerated dose at 1 year, suggesting follow-up for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07137494

A Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma (CNSL)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~12 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:MB-CART19.1 Cellular Therapy

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To identify the maximum tolerated dose (MTD)
Measured over 1 year

Conditions

Primary Central Nervous System (CNS) Lymphoma
Secondary Central Nervous System Lymphoma

Explore related trials

Primary Central Nervous System LymphomaSecondary Central Nervous System Lymphoma

NCT07137494

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering at Bergen (Limited Protocol Activities)

    Montvale, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)

    Middletown, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering at Nassau (Limited Protocol Activities)

    Uniondale, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)

    Commack, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering at Westchester (Limited Protocol Activities)

    Harrison, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ivan Kotchetkov, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Ivan Kotchetkov, MD
[email protected]
212-610-0751
Email the study team

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Eligibility criteria

Inclusion

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/refractory primary or secondary CNSL patients. All relapsed//refractory patients need to have received at least one prior CNS-directed methotrexate-based therapy. There is no restriction on the number of recurrences.
For relapsed patients, parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI of the brain or head CT) within 21 days of study consent.
For refractory patients, there must be residual disease after their last line of therapy.
For patients with leptomeningeal disease only, CSF cytology and/or flow cytometry must document CSF findings consistent with CSF involvement by lymphoma and/or imaging findings consistent with CSF disease within 21 days of study registration (at the discretion of the investigator).
Creatinine Clearance ≥ 40 ml/min/m2, direct bilirubin ≤2.0 mg/100 ml, AST and ALT ≤3.0x upper limit of normal (ULN)
Adequate pulmonary function as assessed by ≥90% oxygen saturation on room air by pulse oximetry.
Must be able to tolerate both MRI and CT scans
Must be able to tolerate lumbar puncture and/or Ommaya taps
Must have been either off corticosteroids, or on a stable or decreasing dose of dexamethasone equivalent ≤ 2 mg daily for 7 days before apheresis and 72 hours prior to CAR T cell infusion o Use of corticosteroids to treat CAR T cell toxicities per MSKCC guidelines is permitted

Exclusion

ECOG performance status \>2
Active systemic lymphoma (i.e. involvement outside of the CNS)
If the most recent CSF or brain tissue sample demonstrates absence of CD19 expression
Size of any single CNS lymphoma lesion exceeds 3 cm in maximal diameter in eloquent brain structures.
Prior treatment of systemic lymphoma with CD19-targeted CAR T cells
Pregnant or lactating patients. Patients of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.
Impaired cardiac function (LVEF \<40%) as assessed by most recent ECHO in the last 1 year.
Patients with autoimmune disease requiring systemic T cell-suppressive therapy.
Patients with following cardiac conditions will be excluded:
New York Heart Association (NYHA) stage III or IV congestive heart failure
Myocardial infarction ≤6 months prior to enrollment
History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration ≤6 months prior to enrollment
Patients with ocular lymphoma in the absence of other CNS involvement
Patient has received chemotherapy, monoclonal antibodies or targeted anticancer therapy ≤ 4 weeks or 5 half-lives, whichever is shorter, or 6 weeks for nitrosourea or mitomycin-C, or 3 months since allogeneic hematopoietic stem cell transplantation, prior to starting the study drug, or the patient has not recovered from the side effects of such therapy.
Patients with HIV
Patients with active hepatitis B or hepatitis C infection (as manifested by either detectable hepatitis B virus DNA by PCR, hepatitis virus C RNA by PCR, or positivity for hepatitis B surface or core antigen)
Patients with uncontrolled systemic fungal, bacterial, viral or other infection at time of leukapheresis or at time of CAR T cell infusion
Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin
Patients exposed to immune checkpoint inhibitor within 8 weeks
Use of herbal supplements are not allowed on study
Any other issue which, in the opinion of the treating physician or PI, would make the patient ineligible for the study.

What this trial measures

  • To identify the maximum tolerated dose (MTD)1 year

    The maximum tolerated dose (MTD) is defined as the highest dose level where a Dose limiting toxicity (DLT) occurs within at most one out of six patients treated. DLT is defined as any of the following adverse events (AEs) that occur within 28 days of the MB-CART19.1 infusion, based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0, TIAN grading65, or the ASTCT Consensus Grading guidelines for Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity (ICANS).