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NCT07137494 · ClinicalTrials.gov registry record · Phase 1
A Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma (CNSL)
A Phase 1 study of Secondary Central Nervous System Lymphoma and Primary Central Nervous System (CNS) Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 7
- Study locations
NCT07137494: Recruiting Phase 1 study of Secondary Central Nervous System Lymphoma and Primary Central Nervous System (CNS) Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT07137494 is a Phase 1 study of Secondary Central Nervous System Lymphoma and Primary Central Nervous System (CNS) Lymphoma that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 12 participants, below the 38-participant average among 7 other Secondary Central Nervous System Lymphoma trials with a reported enrollment target (68% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07137494, a Phase 1 study of Secondary Central Nervous System Lymphoma and Primary Central Nervous System (CNS) Lymphoma, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- BIOLOGICAL MB-CART19.1 Cellular Therapy
Study Locations (7)
New York
- Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering at Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
- Memorial Sloan Kettering at Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering at Basking Ridge (All Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering at Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-08-14 |
| Est. Completion | 2028-08 |
| Phase | Phase 1 |
What NCT07137494 shows while recruiting
NCT07137494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 38-participant average among 7 other Secondary Central Nervous System Lymphoma trials with a reported enrollment target (68% lower).
The record links to 2 conditions, with Secondary Central Nervous System Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which MB-CART19.1 Cellular Therapy is the first listed.
NCT07137494 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT07137494 about?
NCT07137494 is a clinical study titled "A Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma (CNSL)". 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.
What is the current status of trial NCT07137494?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-08-14. Estimated completion is 2028-08.
What conditions does trial NCT07137494 study?
This clinical trial studies the following conditions: Secondary Central Nervous System Lymphoma, Primary Central Nervous System (CNS) Lymphoma.
What interventions are being tested in trial NCT07137494?
The interventions under investigation include: MB-CART19.1 Cellular Therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT07137494?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07137494 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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