ST-067 in Combination With CD19-Directed CAR T-Cell Therapy (Liso-cel) in Relapsed/Refractory Large B-Cell Lymphoma

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT07098364
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Recurrent Grade 3b Follicular Lymphoma
  • Recurrent High-Grade B-Cell Lymphoma
  • Recurrent Indolent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Primary Mediastinal Large B-Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Refractory Grade 3b Follicular Lymphoma
  • Refractory High-Grade B-Cell Lymphoma
  • Refractory Indolent B-Cell Non-Hodgkin Lymphoma
  • Refractory Primary Mediastinal Large B-Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Vevoctadekin — BIOLOGICAL
    Given SC
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Leukapheresis — PROCEDURE
    Undergo leukapheresis
  • Lisocabtagene Maraleucel — BIOLOGICAL
    Given IV
  • Lumbar Puncture — PROCEDURE
    Undergo lumbar puncture
  • Lymphodepletion Therapy — PROCEDURE
    Undergo lymphodepletion chemotherapy
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan
  • X-Ray Imaging — PROCEDURE
    Undergo x-ray
  • Biospecimen Collection — PROCEDURE
    Undergo blood and CSF sample collection

Study Details

This phase I/II trial tests the safety, side effects, and best dose/regimen of ST-067 in combination with CD19-directed chimeric antigen receptor (CAR) T-cell therapy (liso-cel) and how well it works in treating patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (recurrent) or LBCL that has not responded to previous treatment (refractory). ST-067 is an engineered variant of the human cytokine interleukin-18 that may help the immune system kill cancer cells. Lisocabtagene maraleucel (liso-cel) is an autologous CAR T-cell therapy prepared using the person's own immune system (a group of cells, tissues, and organs that protect the body from attack by bacteria, viruses, and cancer cells) to fight the cancer. Giving ST-067 in combination with liso-cel may better treat patients with relapsed/refractory LBCL.

Key Dates

Start date
Dec 27, 2025
Status verified
Jan 2026
Primary completion
Oct 4, 2030
Completion
Oct 4, 2043

Study Design

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

Arms

  • Experimental: Treatment (liso-cel, ST-067)
    Patients undergo leukapheresis and lymphodepleting chemotherapy between days -5 to -3 prior to treatment and receive liso-cel IV on day 0. Patients then receive ST-067 SC weekly on days 14, 21, and 28 or days 10, 17, and 24. Patients may continue to receive maintenance ST-067 SC at day 35 once weekly. Treatment continues for up to 8 doses in the absence of disease progression or unacceptable toxicity. Patients undergo x-ray imaging, and ECHO or MUGA during screening. Patients also undergo CT and/or PET as well as lumbar puncture for CSF collection and bone marrow aspiration and biopsy as clinically indicated during screening and follow-up. Patients undergo blood sample collection throughout the study.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Up to 4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Immunotherapy Intake Coordinator
[email protected]
206-606-4668
Alexandre V. Hirayama, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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