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New treatment option for Primary Central Nervous System (CNS) Lymphoma
Official title A Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma (CNSL)
ClinicalTrials.gov ID: NCT07137494
What this study is testing
What is MB-CART19.1 Cellular Therapy?
MB-CART19.1 Cellular Therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary central nervous system (cns) lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- For relapsed patients, parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI of the brain or head CT) within 21...
- For refractory patients, there must be residual disease after their last line of therapy.
You likely can't join if
- 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
- Pregnant or lactating patients. Patients of childbearing age should use effective contraception while on this study and continue for 1 year after all...
See the full eligibility 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 relapsed//refractory patients need to have received at least one prior CNS-directed methotrexate-based therapy. There is no restriction on the number of...
- 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...
- 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.