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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07137494
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MB-CART19.1 Cellular Therapy — BIOLOGICAL
    MB-CART19.1 will be infused as a single infusion during an inpatient admission.

Study Details

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.

Key Dates

Start date
Aug 14, 2025
Status verified
Jun 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MB-CART19.1 Cellular Therapy
    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.

Primary Outcome Measure

To identify the maximum tolerated dose (MTD) [ Time Frame: 1 year ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey07920
Ivan Kotchetkov, MD
212-610-0751
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Ivan Kotchetkov, MD
212-610-0751
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Ivan Kotchetkov, MD
212-610-0751
Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)CommackNew York11725
Ivan Kotchetkov, MD
212-610-0751
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)HarrisonNew York10604
Ivan Kotchetkov, MD
212-610-0751
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Ivan Kotchetkov, MD
[email protected]
212-610-0751
Maria Palomba, MD
646-608-3711
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)UniondaleNew York11553
Ivan Kotchetkov, MD
212-610-0751

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering at Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering at Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering at Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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