Plasmablastic Lymphoma study: Elranatamab
Official title HEME-25 Open-Label Feasibility Study of Elranatamab Utilized as Consolidation in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV
ClinicalTrials.gov ID: NCT07647432
What this study is testing
What is Elranatamab (Elra)?
an investigational subcutaneous injectable medicine being studied as a potential consolidation treatment for plasmablastic lymphoma is designed to bind BCMA on cancer cells and CD3 on T‑cells, directing the immune system to attack the lymphoma cells
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether giving Elranatamab as consolidation is feasible for people with plasmablastic lymphoma.
- Who it's for
- You may be able to join if you have plasmablastic lymphoma, have finished first‑line chemotherapy, and your disease responded.
- What's involved
- You will receive Elranatamab (a lab‑made antibody) as an additional treatment. You will have clinic visits and simple tests to check your health.
- Time commitment
- The study lasts several months after chemo and includes regular visits to the clinic.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility criteria
- 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.
- 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...
- 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.
- 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
- Receiving effective combined antiretroviral therapy
- CD4+ T-cell count ≥ 50 cells/mcL within 4 weeks before enrollment
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.