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Plasmablastic LymphomaPhase 1HEME-25NCT07647432

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

A Phase 1 study testing Elranatamab (Elra) in people with Plasmablastic Lymphoma and HIV, run by University of Illinois Chicago at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plasmablastic Lymphoma, HIV, Consolidation
What is being tested?
Elranatamab (Elra)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
21 Oct 2026to 1 Dec 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Paul Rubinstein, MD contact

312 413 1300

paulgr@uic.edu

United States1 site, 1 recruiting

  • University of Illinois at Chicago

    Chicago, Illinois, 60608

    Meredith Russell, BS, 312-355-5112, mrussel3@uic.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

Patients after definitive therapy 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).

Participants will undergo disease assessment with PET/CT at the end of Cycle 3, post-end of treatment (EOT) visit, and every 6 months thereafter (±2 weeks) for up to 2 years to assess recurrence and survival. Routine clinical follow-up will continue every 3 months, as per the standard of care (SOC).

Being tested
Elranatamab (Elra)
Medical subject headings
Plasmablastic Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07647432
Study groupRoleWhat they receive
Single-arm Open label study of Elra of pts with PBLExperimentalPatients 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).
Receives: Drug: Elranatamab (Elra)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of giving Elra in consolidation after therapy of PBL

    Evaluation of feasibility of (Elra) consolidation following definitive therapy in patients with PBL, defined as the proportion of patients completing at least 3 cycles (12 weeks) of consolidation therapy.

    Measured: 12 weeks ( 3 cycles)

  2. Estimate the complete response in HIV+/ HIV- patients

    Estimate the complete response (CR) rate (per 2014 Lugano criteria)(1) for patients after 6 cycles of consolidation, stratified by HIV status.

    Measured: 6 months

  3. 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.

    Measured: 6 months

Secondary outcomes (4)

  1. Assess event-free survival, progression-free and overall survival of Elra

    Assess event-free survival (EFS), progression-free survival (PFS), and overall survival (OS) at 1- and 2-year post-completion of Elra consolidation

    Measured: 1 year and 2 year

  2. Estimate the conversion rate of PR to CR after consolidation

    Estimate the conversion rate from pre-consolidation partial response (PR) to CR at the end of Cycle 3 and Cycle 6.

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

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

    Evaluate quality of life (QoL) outcomes as measured by changes from baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - High-Grade Non-Hodgkin Lymphoma 29 items (EORTC QLQ-NHL-HG29) scores.

    Measured: 6 months

  4. Assess the effects of Elra on CD4 T-cell counts and HIV-1 viral load

    Assess the effects of Elra on CD4 T-cell counts and HIV-1 viral load in people with HIV (PWH).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2026
  2. Study start21 Oct 2026
  3. Primary completion1 Dec 2029 (estimated)
  4. Study completion1 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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).
Masking
None (open label)
Enrolment
17 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07647432
Sponsor's protocol ID
2025-1210
Other IDs
HEME-25
Acronym
HEME-25
Status last verified
Oct 2026
First submitted
9 Jun 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Elranatamab (Elra) in people with Plasmablastic Lymphoma and HIV, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paul Rubinstein, MD (312 413 1300, paulgr@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of giving Elra in consolidation after therapy of PBL (time frame: 12 weeks ( 3 cycles)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07647432.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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