Actively Recruiting
ST-067 With CD19-Directed CAR T-Cell Therapy (Liso-cel) for Relapsed/Refractory Large B-Cell Lymphoma
Led by Fred Hutchinson Cancer Center · Updated on 2026-01-14
33
Participants Needed
1
Research Sites
678 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
S
Simcha Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how safe and effective the combination of ST-067, an engineered variant of interleukin-18, with CD19-directed CAR T-cell therapy (liso-cel) is for treating patients with relapsed or refractory large B-cell lymphoma (LBCL). This phase I/II trial aims to find the best dose and regimen while studying side effects and treatment response. The study focuses on LBCL patients whose disease has returned after improvement or who did not respond to prior treatments. Participants first undergo leukapheresis to collect immune cells and receive lymphodepleting chemotherapy before being given liso-cel intravenously on day 0. ST-067 is then given by subcutaneous injection weekly on specific days after liso-cel infusion, with possible maintenance doses continuing weekly up to eight doses if tolerated and disease progression does not occur. The study includes detailed imaging scans such as x-rays, CT, PET, echocardiography or MUGA scans during screening and follow-up, as well as lumbar puncture and bone marrow procedures as needed. Throughout the trial, patients have blood samples collected regularly and are followed for safety and treatment response for up to four years. Follow-up visits occur at 3, 6, 9, and 12 months after CAR T-cell infusion, followed by long-term monitoring according to standard care. Researchers assess adverse events, dose-limiting toxicities, response rates, progression-free survival, and overall survival to understand the treatment's impact on LBCL.
CONDITIONS
Brief Title
ST-067 in Combination With CD19-Directed CAR T-Cell Therapy (Liso-cel) in Relapsed/Refractory Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age 18 years or older at consent
- Diagnosis of large B-cell lymphoma, including diffuse large B-cell lymphoma and related subtypes
- At least two prior systemic therapy treatments
- FDA-approved indication for treatment with liso-cel
- Active lymphoma confirmed by PET imaging or pathology
- Evidence or high likelihood of CD19 expression on tumor cells
- Karnofsky performance status of 60% or higher
- Adequate bone marrow function for lymphodepletion chemotherapy
- Creatinine clearance over 30 mL/min/1.73 m2
- Liver enzymes and bilirubin within specified limits
- Adequate lung function by pulmonary testing
- Left ventricular ejection fraction of 40% or higher
- Women of reproductive potential must agree to contraception for 30 days after last study dose
- Men with partners of reproductive potential must use barrier contraception for 90 days after last study dose
- Ability to understand and provide informed consent
- Willingness to comply with study visits and procedures
You will not qualify if you...
- Planned use of out-of-specification liso-cel product
- History of other cancers except certain treated skin, prostate, breast, cervical, or early-stage cancers in remission
- Use of high-dose corticosteroids or systemic immunosuppression shortly before treatment
- Prior treatment with any CD19 CAR T-cell therapy
- Active graft versus host disease or recent systemic GVHD therapy in transplant recipients
- Active hepatitis B or C infection
- Known HIV infection
- Pregnant or breastfeeding women
- Prior treatment with IL-1 or IL-18 agonists or recent investigational agents
- Active autoimmune or inflammatory disorders requiring immunosuppression except certain stable conditions
- Recent significant cardiovascular events or unstable heart conditions
- Serious ECG abnormalities
- Clinically relevant central nervous system diseases or active brain involvement by cancer
- History of solid organ transplantation
- Active, serious, uncontrolled infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including x-ray imaging, echocardiography or MUGA, CT and/or PET scans, lumbar puncture, bone marrow aspiration and biopsy as clinically indicated
Duration - Up to 8 weekly doses starting from day 0
Participants undergo leukapheresis and lymphodepleting chemotherapy prior to receiving lisocabtagene maraleucel (liso-cel) intravenously on day 0. They then receive ST-067 subcutaneously weekly on specified days with the option to continue maintenance doses in the absence of disease progression or unacceptable toxicity.
Weekly visits for up to 8 weeks for treatment administration
Duration - Up to 12 months with long-term follow-up thereafter
Participants are followed up at 3, 6, 9, and 12 months after CAR T-cell infusion with additional assessments including CT and/or PET scans, lumbar puncture, bone marrow aspiration and biopsy as clinically indicated. Blood samples are collected throughout the study.
Visits at 3, 6, 9, and 12 months post-infusion with additional visits as needed
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
I
Immunotherapy Intake Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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