RECRUITING

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

Conditions

Primary Central Nervous System (CNS) Lymphoma Secondary Central Nervous System Lymphoma MB-CART19.1 Cellular Therapy Relapsed/Refractory CliniMACS Prodigy Device

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-08-14

Study Completion:2028-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07137494

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 recurrent/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 recurrent/refractory 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 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 prednisone equivalent ≤ 10 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	* 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 * 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.

Inclusion Criteria

Exclusion Criteria

* 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 recurrent/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 recurrent/refractory 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 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 prednisone equivalent ≤ 10 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

* 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
* 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.

Contacts and Locations

Study Contact

Ivan Kotchetkov, MD

CONTACT

212-610-0751

kotcheti@mskcc.org

Maria Palomba, MD

CONTACT

646-608-3711

Principal Investigator

Ivan Kotchetkov, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-14

Study Completion Date2028-08

Study Record Updates

Study Start Date2025-08-14

Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

MB-CART19.1 Cellular Therapy
Relapsed/Refractory
CliniMACS Prodigy Device

Additional Relevant MeSH Terms

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