Primary Central Nervous System (CNS) LymphomaPhase 1NCT07137494
A Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma (CNSL)
A Phase 1 study testing MB-CART19.1 Cellular Therapy in people with Primary Central Nervous System (CNS) Lymphoma and Secondary Central Nervous System Lymphoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Central Nervous System (CNS) Lymphoma, Secondary Central Nervous System Lymphoma
- What is being tested?
- MB-CART19.1 Cellular Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 7 sitesUnited States
- Study dates
- 14 Aug 2025to Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- ECOG performance status >2
- o Patients with ECOG status of 2 will be enrolled at the discretion of the PI
- 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
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Palomba, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Ivan Kotchetkov, MD, 212-610-0751
- Recruiting
Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Ivan Kotchetkov, MD, 212-610-0751
- Recruiting
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Ivan Kotchetkov, MD, 212-610-0751
- Recruiting
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Ivan Kotchetkov, MD, 212-610-0751
- Recruiting
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Ivan Kotchetkov, MD, 212-610-0751
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Ivan Kotchetkov, MD, 212-610-0751, kotcheti@mskcc.org
Maria Palomba, MD, 646-608-3711
- Recruiting
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Ivan Kotchetkov, MD, 212-610-0751
About this study
Official title: A Phase I Study of MB-CART19.1 Cellular Therapy for Relapsed/Refractory Primary and Secondary Central Nervous System Lymphoma (CNSL) Using On- Site Manufacturing With the CliniMACS Prodigy Device
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.
- Being tested
- MB-CART19.1 Cellular Therapy
- Keywords
- MB-CART19.1 Cellular Therapy, Relapsed/Refractory, CliniMACS Prodigy Device
- Medical subject headings
- Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB-CART19.1 Cellular TherapyBiological
MB-CART19.1 will be infused as a single infusion during an inpatient admission.
| Study group | Role | What they receive |
|---|---|---|
| MB-CART19.1 Cellular Therapy | Experimental | Following enrollment, patients will undergo leukapheresis of peripheral blood for mononuclear cell collection, followed by further T cell enrichment, activation and genetic modification using a lentiviral vector encoding a CD19 targeted CAR. These T cells will be expanded and after the appropriate number of cells is generated, the modified T cells may be infused fresh or frozen for later use according to standard operating procedures. Modified T cell infusions will be administered 2-7 days following completion of the conditioning chemotherapy. Serial sampling of blood and cerebrospinal fluid (CSF) will be performed following treatment to assess toxicity, therapeutic effects, and survival of the genetically modified T cells. Receives: Biological: MB-CART19.1 Cellular Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the maximum tolerated dose (MTD)
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start14 Aug 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Central Nervous System (CNS) LymphomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- It is modeled on a 3+3 design.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Miltenyi Biomedicine GmbH
- Responsible party
- Sponsor
- Investigators
- Ivan Kotchetkov, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137494
- Sponsor's protocol ID
- 25-066
- Status last verified
- Jun 2026
- First submitted
- 15 Aug 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of MB-CART19.1 Cellular Therapy for Relapsed/Refractory Primary and Secondary Central Nervous System Lymphoma (CNSL) Using On- Site Manufacturing With the CliniMACS Prodigy Device
- ClinicalTrials.gov ID
- NCT07137494
- Acronym / sponsor ID
- 25-066
- Keywords
- MB-CART19.1 Cellular Therapy, Relapsed/Refractory, CliniMACS Prodigy Device
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Miltenyi Biomedicine GmbH
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It is modeled on a 3+3 design.
| Arm | Type | Receives |
|---|---|---|
| MB-CART19.1 Cellular Therapy | Experimental | Biological: MB-CART19.1 Cellular TherapyFollowing enrollment, patients will undergo leukapheresis of peripheral blood for mononuclear cell collection, followed by further T cell enrichment, activation and genetic modification using a lentiviral vector encoding a CD19 targeted CAR. These T cells will be expanded and after the appropriate number of cells is generated, the modified T cells may be infused fresh or frozen for later use according to standard operating procedures. Modified T cell infusions will be administered 2-7 days following completion of the conditioning chemotherapy. Serial sampling of blood and cerebrospinal fluid (CSF) will be performed following treatment to assess toxicity, therapeutic effects, and survival of the genetically modified T cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (22 listed)
- ECOG performance status >2
- o Patients with ECOG status of 2 will be enrolled at the discretion of the PI
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MB-CART19.1 Cellular TherapyMB-CART19.1 will be infused as a single infusion during an inpatient admission. | Biological | MB-CART19.1 Cellular Therapy |
Primary outcome
To identify the maximum tolerated dose (MTD)
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Palomba, MD contact
Ivan Kotchetkov, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MB-CART19.1 Cellular Therapy in people with Primary Central Nervous System (CNS) Lymphoma and Secondary Central Nervous System Lymphoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan Kotchetkov, MD (212-610-0751, kotcheti@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the maximum tolerated dose (MTD) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.