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

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

Exclusion Criteria:

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
  • Squamous cell carcinoma limited to the skin
  • Carcinoma in situ of the cervix or breast
  • Adequately treated lentigo malignant melanoma
  • Localized prostate cancer
  • Active therapy consists of adjuvant or maintenance therapy to reduce the risk of recurrence of a malignancy that was previously treated with curative intent and with no evidence of active disease within 2 years prior to screening
• Pregnant or nursing
• PWH with a history of AIDS-defining opportunistic infection within the past year
• Receipt of a live vaccine within 28 days prior to the first dose of study treatment