Elranatamab After First Treatment in Plasmablastic Lymphoma, With or Without HIV

Trial details

Who runs it

University of Illinois Chicago

Trial code

NCT07647432

Record updated

26 October 2026

Original description

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.Read full original descriptionShow less

HEME-25 Open-Label Feasibility Study of Elranatamab Utilized in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV in Consolidation After Definitive Therapy (The EPIC Study)

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.

Inclusion: Age ≥ 18 years at time of consent; ECOG PS 0 or 1; Histologically and immunophenotypically confirmed PBL; Ann Arbor stage at initial diagnosis: stage I with LDH > 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. Date of end-of-treatment response evaluation must be within 8 weeks prior to enrollment; Adequate bone marrow function with recovery from prior therapy (without growth factor or transfusion support), defined as:; ANC ≥ 500 cells/mcL; Platelet count ≥ 50,000 cells/mcL; Hemoglobin ≥8 g/dL; Adequate renal function defined by an estimated creatinine clearance ≥30 mL/min (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or according to local institutional standard method); Adequate hepatic function characterized by the following:; Total bilirubin ≤2 x ULN (≤3 x ULN if documented Gilbert's syndrome); AST ≤2.5 x ULN; ALT ≤2.5 x ULN; 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 IRB ICF and HIPAA authorization. If a subject is unable to consent, an 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: Prior BCMA bispecific therapy; Receiving any other investigational agents; 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; Receipt of a live vaccine within 28 days prior to the first dose of study treatment; Stable or progressive disease following front-line therapy as determined by the investigator; 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; PWH with a history of AIDS-defining opportunistic infection within the past year; Expected survival < 2 months; Pregnant or nursing.

ClinicalTrials.gov NCT07647432