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

NCT07647432 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-1210
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Plasmablastic Lymphoma; Hiv; Consolidation

Outcome Measures

Primary Outcomes (3)

• Evaluation of Elra consolidation therapy

  Evaluation of completion of (Elra) consolidation following definitive therapy in patients with PBL, defined as the proportion of patients completing at least 3 cycles

  12 weeks ( 3 cycles)

• Estimate the complete response in HIV+/ HIV- patients

  Estimate the complete response (CR) rate (per 2014 LUGANO criteria)Ref . in HIV-positive and HIV-negative patients after 6 months of consolidation.

  6 months

• Evaluate the safety and tolerability of Elra consolidation

  To evaluate the safety and tolerability of Elra consolidation, including the incidence, severity, and management of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), assessed by ASTCT consensus criteria.

  6 months

Secondary Outcomes (4)

• Assess event-free survival, progression-free and overall survival of Elra

  1 year and 2 year

• Estimate the conversion rate

  Cycle 3 and cycle 6 (12 weeks and 24 weeks)

• Evaluate quality of life (QoL) outcomes as measured by changes from baseline

  6 months

• Assess the effects of Elra on CD4 T-cell counts

  6 months

Study Arms (1)

Single-arm Open label study of Elra of pts with PBL

EXPERIMENTAL

Patients will receive Elra subcutaneously for up to six 28-day cycles, beginning with a step-up dosing schedule (12 mg on day 1, 32 mg on day 4, followed by 76 mg weekly on days 8, 15, and 22 of Cycle 1). Patients will transition to 76 mg every 2 weeks (days 1 and 15) during Cycles 2 and 3, followed by an interim PET/CT assessment at the end of Cycle 3. During Cycles 4 through 6, all patients will receive 76 mg every 4 weeks (on day 1 of each cycle).

Drug: Elranatamab (Elra)

Interventions

Elranatamab (Elra) DRUG

Elra will be administered subcutaneously on day 1, day 4, then weekly on day 8, 15 and day 22 completing 1 cycle. Up to 6 cycles may be given.

Single-arm Open label study of Elra of pts with PBL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Pfizer: collaborator

MeSH Terms

Conditions

Plasmablastic Lymphoma; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes

Central Study Contacts

Paul Rubinstein, MD

CONTACT

312 413 1300; paulgr@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Elra subcutaneously for up to six 28-day cycles, beginning with a step-up dosing schedule (12 mg on day 1, 32 mg on day 4, followed by 76 mg weekly on days 8, 15, and 22 of Cycle 1).

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share