A Study of Epcoritamab and Ibrutinib in 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
NCT07082868
Phase
PHASE1
Status
Recruiting

Conditions

  • Central Nervous System Lymphoma
  • Primary Central Nervous System Lymphoma
  • Primary Central Nervous System Lymphoma (PCNSL)
  • Refractory Primary Central Nervous System Lymphoma
  • Relapsed Primary Central Nervous System Lymphoma
  • Secondary Central Nervous System Lymphoma
  • Secondary Central Nervous System Lymphoma (SCNSL)

Eligibility Criteria

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

Interventions

  • ibrutinib — DRUG
    Ibrutinib should be self-administered daily by the participant and should be taken at approximately the same time each day
  • Epcoritamab — DRUG
    Epcoritamab will be administered at the study site clinic, as a SC injection

Study Details

The purpose of this study is to find out whether the combination of epcoritamab and ibrutinib is a safe treatment approach that causes few or mild side effects in people with relapsed/refractory primary central nervous system lymphoma (PCNSL) or secondary central nervous system lymphoma (SCNSL).

Key Dates

Start date
Aug 13, 2025
Status verified
Jun 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
26 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Relapsed or refractory PCNSL (n=6)
  • Experimental: Cohort B1
    Relapsed or refractory PCNSL (n=10)
  • Experimental: Cohort B2
    Relapsed or refractory PCNSL (n=10)

Primary Outcome Measure

Number of dose limiting toxicities/DLTs [ Time Frame: 8 weeks ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Christian Grommes, MD
212-610-0344
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Christian Grommes, MD
212-610-0344
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Christian Grommes, MD
212-610-0344
Memorial Sloan Kettering Commack (Limited Protocol Activities)CommackNew York11725
Christian Grommes, MD
212-610-0344
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Christian Grommes, MD
212-610-0344
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Christian Grommes, MD
212-610-0344
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Christian Grommes, MD
212-610-0344
University of Utah (Data Collection Only)Salt Lake CityUtah84112
Narendranath Epperia, MD, MS, FACP
801-585-2626

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