RecruitingPhase 1Phase 2NCT07098364

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)


Sponsor

Fred Hutchinson Cancer Center

Enrollment

33 participants

Start Date

Dec 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ST-067 given alongside an approved immune cell therapy (liso-cel, a type of CAR-T therapy) for people with large B-cell lymphoma — an aggressive blood cancer — that has come back or is not responding to previous treatments. ST-067 aims to make the CAR-T therapy work better and last longer. **You may be eligible if...** - You are 18 or older - You have large B-cell lymphoma that has not responded to at least 2 prior treatments and qualifies for liso-cel therapy - Your tumor expresses a protein called CD19 - Your heart, lungs, kidneys, and liver are functioning adequately - Your blood counts are sufficient for the pre-treatment chemotherapy - You have a Karnofsky performance score of 60% or higher **You may NOT be eligible if...** - You have previously received any CD19 CAR-T therapy - You have active hepatitis B, hepatitis C, or HIV - You have active autoimmune disease requiring systemic treatment (some exceptions apply) - You have had a serious heart event (heart attack, severe heart failure) in the past 6 months - You are pregnant or breastfeeding - You have active brain involvement from lymphoma (some exceptions for leptomeningeal disease) - You have had a solid organ transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALVevoctadekin

Given SC

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREEchocardiography Test

Undergo ECHO

PROCEDURELeukapheresis

Undergo leukapheresis

BIOLOGICALLisocabtagene Maraleucel

Given IV

PROCEDURELumbar Puncture

Undergo lumbar puncture

PROCEDURELymphodepletion Therapy

Undergo lymphodepletion chemotherapy

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

PROCEDUREPositron Emission Tomography

Undergo PET scan

PROCEDUREX-Ray Imaging

Undergo x-ray

PROCEDUREBiospecimen Collection

Undergo blood and CSF sample collection


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07098364


Related Trials