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

StatusSuspended
PhasePhase 1/2
Started2025-12-27
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
critical
Recruiting→Suspended Study Status, Contacts/Locations v7
Recruitment suspended: Insufficient funding
Trial statusRecruiting→Suspended
Study sitesdetails revised at 1 of 1 site
2026-07-17
minor
2 amendments v5-v6
2 re-verifications since 2026-01-13, no change to tracked fields
2026-01-05
minor
Study Status v4
Start dateestimated 2026-01-08→confirmed 2025-12-27
2025-12-08
minor
Study Status v3
Start date2025-12-01→2026-01-08
2025-11-10
minor
Study Status v2
Start date2025-11-01→2025-12-01
2025-10-08
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2026-01-01→2025-11-01
Study sitesdetails revised at 1 of 1 site
2025-07-31
minor
Original filing
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.
Trial Details
NCT Number NCT07098364
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: Simcha Therapeutics
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 +4 more
Enrollment 33 participants
Start Date 2025-12-27
Primary Completion 2030-10-04 (estimated)
Study Completion 2043-10-04 (estimated)
Updated on ClinicalTrials.gov 2026-09-11