HEME-25: Open-Label Feasibility Study of Elranatamab Utilized in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV

Starting soon · Phase 2/Phase 3

Conditions studied: Plasmablastic Lymphoma, Hiv, Consolidation

In brief

This is a single-arm feasibility trial in which patients with histologically confirmed plasmablastic lymphoma (PBL) with or without HIV, who have achieved a Complete Response or Partial Response after definitive frontline chemotherapy, will receive Elranatamab (Elra) consolidation.

Key facts

Study ID

NCT07647432

Run by

University of Illinois at Chicago

People needed

17

Starts

2026-12-01

Expected to finish

2030-12-01

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years at time of consent
• ECOG performance status (PS) 0 or 1
• Histologically and immunophenotypically confirmed PBL
• Ann Arbor stage at initial diagnosis: stage I with lactate dehydrogenase (LDH) > upper limit of normal (ULN) and/or bulky disease >7.5 cm or stage II-IV
• Received definitive front-line therapy for PBL with end-of-treatment PR or CR
• Adequate bone marrow function with recovery from prior therapy, defined as:
• ANC ≥ 500 cells/mcL
• Platelet count ≥ 50,000 cells/mcL
• Availability of archival tumor tissue (block or unstained slides) for mandatory central pathology review and correlative BCMA testing. Central pathology review and BCMA testing may be completed after enrollment.
• Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization. If a subject is unable to consent, a LAR may provide consent on their behalf.
• As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study
• If capable of becoming pregnant: Negative serum or urine pregnancy test
• If HIV-positive:
• Receiving effective combined antiretroviral therapy
• CD4+ T-cell count ≥ 50 cells/mcL within 4 weeks before enrollment

You may not qualify if…

• Key inclusion criteria:
• Age ≥ 18 years at time of consent
• ECOG performance status (PS) 0 or 1
• Histologically and immunophenotypically confirmed PBL
• Ann Arbor stage at initial diagnosis: stage I with lactate dehydrogenase (LDH) > upper limit of normal (ULN) and/or bulky disease >7.5 cm or stage II-IV
• Received definitive front-line therapy for PBL with end-of-treatment PR or CR
• Adequate bone marrow function with recovery from prior therapy, defined as:
• ANC ≥ 500 cells/mcL
• Platelet count ≥ 50,000 cells/mcL
• Availability of archival tumor tissue (block or unstained slides) for mandatory central pathology review and correlative BCMA testing. Central pathology review and BCMA testing may be completed after enrollment.
• Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization. If a subject is unable to consent, a LAR may provide consent on their behalf.
• As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study
• If capable of becoming pregnant: Negative serum or urine pregnancy test
• If HIV-positive:
• Receiving effective combined antiretroviral therapy
• CD4+ T-cell count ≥ 50 cells/mcL within 4 weeks before enrollment
• Key exclusion criteria:
• Prior BCMA bispecific therapy
• Stable or progressive disease following front-line therapy as determined by the investigator
• Receiving any other investigational agents
• Expected survival < 2 months
• Known or suspected PBL involvement of the parenchymal brain or spinal cord at diagnosis. Asymptomatic leptomeningeal disease only will be allowed.
• Uncontrolled intercurrent illness, including but not limited to uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Concurrent malignancy requiring active therapy within the last 3 years, except for the following:
• Basal cell carcinoma limited to the skin

Full record on ClinicalTrials.gov

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