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 at Chicago.
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
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2030
- Phase
- Phase 1
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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
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).
- Conditions
- Plasmablastic Lymphoma, HIV, Consolidation
- 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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Elranatamab (Elra) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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)
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
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)
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
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.
- First posted15 Jun 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmablastic LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647432
- Sponsor's protocol ID
- 2025-1210
- Other IDs
- HEME-25
- Acronym
- HEME-25
- Status last verified
- May 2026
- First submitted
- 9 Jun 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No