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

Sponsor
University of Illinois at Chicago
Study ID
NCT07647432
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Consolidation
  • Hiv
  • Plasmablastic Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jun 15, 2026
Start date
Dec 1, 2026
Status verified
May 2026
Primary completion
Dec 1, 2029
Completion
Dec 1, 2030

Study Design

Enrollment
17 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single-arm Open label study of Elra of pts with PBL
    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).

Primary Outcome Measure

Evaluation of Elra consolidation therapy [ Time Frame: 12 weeks ( 3 cycles) ]

Central Contacts

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