A Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma (CNSL)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
MB-CART19.1 Cellular Therapy
Biological/VaccineMB-CART19.1 will be infused as a single infusion during an inpatient admission.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: MB-CART19.1 Cellular TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Miltenyi Biomedicine GmbH
Collaborator
Source ClinicalTrials.gov