Trials / Recruiting

RecruitingNCT07098364

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

A Phase 1/2 Open-Label Study Evaluating the Safety and Efficacy of ST-067 in Combination With CD19-Directed CAR T-Cell Therapy in Patients With Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL)

Status: Recruiting
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 33 (estimated)

Sponsor: Fred Hutchinson Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

OUTLINE: This is a phase I, dose-escalation study of ST-067 followed by a phase II study. Patients undergo leukapheresis and lymphodepleting chemotherapy between days -5 to -3 prior to treatment and receive liso-cel intravenously (IV) on day 0. Patients then receive ST-067 subcutaneously (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 echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients also undergo computed tomography (CT) and/or positron emission tomography (PET) as well as lumbar puncture for cerebral spinal fluid (CSF) collection and bone marrow aspiration and biopsy as clinically indicated during screening and follow-up. Patients undergo blood sample collection throughout the study. After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months after CAR T-cell infusion, then will be followed per standard of care long-term follow-up until the patient dies, is lost to follow-up, or withdraws consent.

Conditions

Interventions

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

Timeline

Start date: 2025-12-27
Primary completion: 2030-10-04
Completion: 2043-10-04
First posted: 2025-08-01
Last updated: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT07098364. Inclusion in this directory is not an endorsement.