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

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.

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

Interventions

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

Sponsors & Collaborators

• Simcha Therapeutics

  collaborator UNKNOWN

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Alexandre V. Hirayama, MD · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-27

Primary Completion

2030-10-04

Completion

2043-10-04

FDA Drug

Yes

Countries

• United States

Study Locations