Actively Recruiting
ST-067 in Combination With CD19-Directed CAR T-Cell Therapy (Liso-cel) in Relapsed/Refractory Large B-Cell Lymphoma
Led by Fred Hutchinson Cancer Center · Updated on 2026-01-14
33
Participants Needed
1
Research Sites
927 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
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
Official 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 18 years of age or older at the time of consent
- Diagnosed with large B-cell lymphoma (including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B) with at least 2 prior systemic therapies and FDA-approved indication for liso-cel
- Presence of FDG-avid disease on PET scan before lymphodepletion or pathology evidence of active disease
- Evidence of CD19 expression on any prior or current tumor sample or high likelihood based on disease type
- Karnofsky performance status of 60% or higher
- Adequate bone marrow function for lymphodepletion chemotherapy (ANC ≥ 1000 cells/mm³, platelets ≥ 50,000 cells/mm³, hemoglobin ≥ 8 g/dL) unless low counts due to bone marrow lymphoma involvement
- Calculated creatinine clearance above 30 mL/min/1.73 m²
- Liver enzymes (ALT and AST) not exceeding 3 times the upper limit of normal (or 5 times if liver infiltrated by lymphoma) and bilirubin within allowed limits
- Adequate lung function by pulmonary tests (FEV1 and FEV1/FVC ratio ≥ 60%, DLCO ≥ 40%)
- Adequate heart function with left ventricular ejection fraction ≥ 40%
- Women able to become pregnant must agree to use contraception for at least 30 days after last dose of ST-067
- Men with partners able to become pregnant must agree to use barrier contraception for at least 90 days after last dose of ST-067
- Ability to understand and give informed consent
- Willing and able to comply with study visits and procedures, including tumor biopsy if feasible
You will not qualify if you...
- Planned use of out-of-specification liso-cel product
- History of another cancer except adequately treated basal or squamous cell skin cancer, in situ prostate, breast or cervical carcinoma, noninvasive bladder cancer, other treated stage 1 or 2 cancers in remission, or any cancer in remission for at least 2 years
- Planned use of high-dose corticosteroids or systemic immunosuppressants shortly before leukapheresis or liso-cel infusion (topical or inhaled steroids allowed)
- Previous treatment with any CD19 CAR T-cell therapy
- Active graft versus host disease or treatment within 30 days before planned leukapheresis in allogeneic hematopoietic cell transplant recipients
- Known active hepatitis B or C infection
- Known HIV infection
- Pregnant or breastfeeding women
- Prior treatment with IL-1 or IL-18 agonists, biosimilars, or investigational agents within 4 weeks or 5 half-lives before lymphodepletion
- Active autoimmune or inflammatory disorders requiring immunosuppressive therapy, except certain stable or low-risk conditions
- Significant recent cardiovascular events or clinically significant heart disease contraindicating study treatment
- Serious ECG abnormalities including unstable arrhythmias, advanced heart block, severe bradycardia, or prolonged QTc interval
- History or presence of serious central nervous system diseases that contraindicate treatment
- Active brain involvement by cancer excluding certain CNS disease types
- History of solid organ transplant
- Active, serious, uncontrolled infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here